A Prospective, Multicenter, Single-arm, Clinical Investigation Evaluating the Safety and Performance of GATT-Patch for Hemostasis During Open Liver Surgery
Phase: NA
Conditions: Hemorrhage, Surgical
Sponsor: GATT Technologies BV

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GATT Technologies BV 
 
 
A Prospective, Multicenter, Single-arm, Clinical Investigation 
Evaluating the Safety and Performance of GATT-Patch for 
Hemostasis during Open Liver Surgery 
 
Short title: Clinical Safety and Performance of GATT-Patch in Open Liver 
Surgery  
Reference: DHF-01-QR-021    
Version: Version 04 
Date: 28 April 2021 
 
 
GATT Technologies BV 
Novio Tech Campus 
Transistorweg 5 
6534 AT Nijmegen  
The Netherlands 
 
 
Statement of Compliance 
This clinical investigation will be conducted in compliance with ISO 14155:2020 guidelines and 
applicable regulatory requirements, including the Medical Device Regulation (MDR) 2017/745.  
 
Confidentiality Statement 
The information provided in this document is strictly confidential and may not be disclosed to parties 
other than clinical investigation staff, appropriate governmental and regulatory agencies and the 
Ethics Committee directly involved in this clinical investigation. All parties must understand that 
confidential information may not be disseminated further without prior written permission from GATT 
Technologies BV. 
 
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SPONSOR SIGNATURE PAGE 
 
Clinical investigation: 
A Prospective, Multicenter, Single-arm, Clinical Investigation 
Evaluating the Safety and Performance of GATT-Patch for 
Hemostasis during Open Liver Surgery  
Reference: 
 
 
DHF-01-QR-021 
 
Sponsor’s statement 
I, the Sponsor, have reviewed this clinical investigation plan describing the design and specific 
provisions of the clinical investigation. I agree with the content of this document.  
 
 
Sponsor representative name (print) 
 
 
Title 
 
 
Signature 
 
 
 
 
 
Date 
 
Dr Stuart Head, MD PhD
Chief Medical Officer
03/05/2021
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INVESTIGATOR SIGNATURE PAGE 
 
Clinical investigation: 
A Prospective, Multicenter, Single-arm, Clinical Investigation 
Evaluating the Safety and Performance of GATT-Patch for 
Hemostasis during Open Liver Surgery 
Reference: 
DHF-01-QR-021 
 
Investigator’s statement 
I agree to conduct this clinical investigation in accordance with the design and specific provisions of 
this clinical investigation plan; modifications to the clinical investigation are only acceptable with a 
mutually agreed upon clinical investigation plan amendment as approved by the Sponsor and involved 
Ethics Committee(s).  
I agree to await Ethics Committee approval of the clinical investigation plan and informed consent 
form before initiating the clinical investigation, to obtain consent from subjects prior to their 
enrollment, to collect and record data as required by the clinical investigation plan and associated 
case report forms, and to maintain documents related to the clinical investigation for the period of 
time required. 
Confidential 
This document contains confidential information belonging to GATT Technologies BV. Except as may 
be otherwise agreed to in writing, by accepting or reviewing these materials, I agree to hold such 
information in confidence and not to disclose it to others (except where required by applicable law), 
nor use it for unauthorized purposes.  
 
Investigator name (print) 
 
 
Signature 
 
 
 
 
 
Date 
 
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CONTACT INFORMATION SHEET 
Sponsor 
GATT Technologies BV 
Novio Tech Campus 
Transistorweg 5 
6534 AT Nijmegen  
The Netherlands 
Email: info@gatt-tech.com 
Contract Research Organization (CRO) 
Avania BV 
Prof. Bronkhorstlaan 10, building 54  
3723 MB Bilthoven  
The Netherlands  
Phone: +31 (0)30 229 2727  
Medical Monitor  
Email: eu_medicalmonitor@avaniaclinical.com  
Phone: +31 30 229 2727  
Fax: +31 30 228 7755  
 
 
 
 
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SYNOPSIS 
Clinical investigation plan  
Title  
A Prospective, Multicenter, Single-arm, Clinical Investigation Evaluating 
the Safety and Performance of GATT-Patch for Hemostasis during Open 
Liver Surgery  
Short title   
Clinical Safety and Performance of GATT-Patch in Open Liver Surgery  
Reference  
DHF-01-QR-021  
Investigational device   
Name  
GATT-Patch  
Description  
GATT-Patch is a hemostatic patch with dimensions of 100x50 mm, which 
consists of a gelatin patch that is impregnated with a granulate of N-
Hydroxysuccinimide (NHS) ester-functional poly(2-ethyl-2-oxazoline) 
polymer (NHS-POx) and a nucleophilic amine-functional poly(2-ethyl-2-
oxazoline) polymer (NU-POx) particles also referred to as P(EtOx-NH2) 
polymer.  
GATT-Patch will be applied onto the wound site where the flexible and 
resorbable gelatin patch is activated by tissue contact and initiates the 
coagulation cascade, further enhanced by dehydrating the blood to 
concentrate the blood’s solid elements leading to a matrix for platelet 
aggregation and release of coagulation factors enabling fibrin formation 
'trapped' in the gelatin fibers. Once the patch is activated, via the 
combination of P(EtOx-OH-NHS), P(EtOx-NH2) and gelatin, a POx-hydrogel 
is formed. This POx-hydrogel has two effects: firstly, to adhere the patch 
to the tissue and secondly to form a seal across the damaged tissue. Both 
parts together help to ensure that high efficacy hemostasis can be 
achieved.   
Indication for use 
GATT-Patch is indicated for use as an adjunct to hemostasis and as a 
surgical sealant in surgery for minimal, mild or moderate bleeding 
sites when control of bleeding by standard surgical techniques (such as 
suture, ligature or cautery) is ineffective or impractical. GATT-Patch is 
intended to be used for management of hemorrhage during surgeries on 
internal organs, primarily parenchymatous organs such as liver, spleen or 
kidney; or in other abdominal surgeries. GATT-Patch is intended to be 
used by physicians trained in performing specific surgical and minimal 
invasive procedures.  
Indication for use in the clinical 
investigation 
GATT-Patch is intended to be used for management of hemorrhage during 
elective open liver surgery.  
Sponsor  
Name  
GATT Technologies BV  
Contact details  
Transistorweg 5 
6534 AT Nijmegen  
The Netherlands 
info@gatt-tech.com  
Investigation centers   
Number of centers  
Up to 7 sites, with a maximum of 3 sites in Stage I 
Location of centers   
The Netherlands  
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Clinical investigation design  
Design  
This is a pre-market, prospective, single arm, multicenter, first-in-human 
clinical investigation.   
The clinical investigation will be split into 2 stages:  
• 
Stage I of the clinical investigation will enroll a small cohort of 
subjects within which the initial safety of GATT-Patch will be 
evaluated. A maximum of 12 subjects (~25% of the overall 
population) will be treated1 at a maximum of 3 sites, after which 
the enrollment into the clinical investigation will be paused. At 
minimum, 2 subjects shall be treated per site.  
• 
Stage II of the clinical investigation will enroll subjects until 39* 
Stage II subjects have been treated with the investigational 
device. (*Note: The number of Stage II subjects may increase to 
a maximum of 61 treated subjects [56 evaluable Stage II 
subjects, assuming 7.5% drop-out rate] if a sample size increase 
is deemed necessary based on the interim sample size re-
estimation). Stage II will be used to evaluate safety and 
performance of GATT-Patch.  
In both Stage I and Stage II, subjects will follow the same clinical 
investigation pathway. Stage I subjects will be analyzed for safety only, 
whereas Stage II subjects will be analyzed for both safety and 
performance.  
Objective  
To evaluate the clinical safety and performance of GATT-Patch in open liver 
surgery.  
Hypothesis  
The percentage of cases achieving hemostasis at 3 minutes using GATT-
Patch is significantly greater than the literature-based performance goal 
(PG) of 65.4% (i.e., whether GATT-Patch is non-inferior compared to the 
standard of care). Thus, the statistical null (H0) and alternative (H1) 
hypotheses are the following: 
H0: pGATT ≤ 65.4%   
H1: pGATT > 65.4%  
Primary performance endpoint  
The primary performance endpoint is defined as the percentage of cases 
achieving hemostasis at 3 minutes. Hemostasis will be defined by a grade 
of 0 (None/Dry) on the Surface Bleeding Severity Score (SBSS) 2 . 
Achievement of hemostasis will be verified every 30 seconds. 
 
1 Treated subjects include subjects that are actually implanted with the device, or had a treatment attempt with 
the device.  
2 The SBSS provides a validated score for assessment of bleeding at the target site, and consists of 6 subscales 
(0=none, 1=minimal, 2=mild, 3=moderate, 4=severe; not immediately life-threatening, 5=extreme; immediately 
life threatening) 1. 
Spotnitz, W.D., et al., The SPOT GRADE: a new method for reproducibly quantifying 
surgical wound bleeding. Spine, 2018. 43(11): p. E664-E671.). Investigators will be trained on the assessment 
scale prior to the investigation to have consistent assessment of bleeding at the target site. 
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If hemostasis has not been achieved after 5 minutes of application (SBSS 
1-5), then treatment is considered a failure and additional hemostatic 
agents or techniques may be used.  
Secondary performance endpoints  The following secondary endpoints are defined: 
• 
Mean time to hemostasis (seconds)3 
• 
Percentage of hemostasis at 30, 60, 90, 120 and 150 seconds. 
There will be no formal hypothesis testing on the secondary performance 
endpoints. 
Safety endpoints  
The safety of GATT-Patch will be assessed by the nature, severity and 
incidence of device related adverse events. The adverse events found for 
GATT-Patch will be compared to the current knowledge and state of the 
art for hemostatic methods in open liver surgery to assess whether the 
device is associated with acceptable safety outcomes.   
Exploratory endpoints  
In addition to the primary endpoint, the following exploratory endpoints 
will be recorded:  
• 
Surgery Time (minutes)  
• 
Blood loss (mL) during surgery 
• 
Blood Transfusion (mL) during hospitalization 
• 
SBSS (0-5) at the target bleeding site  
• 
Use of adjunct hemostatic agents/techniques (e.g. cautery, 
sutures or staples)  
• 
Amount of material needed versus bleeding surfaces  
• 
User satisfaction (questionnaire)   
Arms and interventions   
This is a single-arm clinical investigation. GATT-Patch will be used to 
control bleeding during open liver surgery. Each surgery will be performed 
according to the standard procedures of the hospital, with exception of the 
use of GATT-Patch. Subjects who signed informed consent and meet the 
eligibility criteria will be treated with the device. GATT-Patch will be used 
if the subject has an appropriate bleeding site (SBSS 1, 2 or 3 and no 
contraindications). 
Follow-up visits  
1 Visit at 6 weeks follow-up (±2 weeks)4  
Total duration  
The enrollment period is expected to take approximately 6 months. The 
per subject duration of the clinical investigation from treatment to final 
follow-up will be approximately 6 weeks. With a 2-week temporary hold 
on enrollment for the safety evaluation, the total expected duration of the 
clinical investigation is, therefore, approximately 8 months.  
Clinical investigation population  
Sample size  
The plan is to enroll and treat the following number of subjects across two 
stages:   
 
3 Note that the mean time to hemostasis will be calculated based on time to hemostasis determined at 30 
seconds intervals.  
4 Some subjects may have an additional phone consultation at 2-6 weeks post-procedure for the assessment of 
safety during Stage I of the clinical investigation. This visit will include assessment of adverse events and will only 
take place for subjects in Stage I of the clinical investigation who did not complete the 6 weeks follow-up visit. 
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• 
Stage I: maximum of 12 subjects  
• 
Stage II: 39 subjects (36 evaluable subjects, assuming 7.5% drop-
out rate)* 
*Note: The number of Stage II subjects may increase to a maximum of 
61 treated subjects (56 evaluable subjects, assuming 7.5% drop-out 
rate) if a sample size increase is deemed necessary based on the 
interim sample size re-estimation 
Therefore, the current plan is to treat a total of up to 51 subjects. However, 
the total sample size may increase to a maximum of 73 (=61+12) treated 
subjects based on the interim sample size re-estimation.    
The sample size of Stage II is powered on the primary endpoint to allow for 
assessment of non-inferiority of GATT-Patch compared to the current 
knowledge (literature-based) of standard of care regarding the percentage 
of subjects achieving hemostasis at 3 minutes. 
Assuming the true percentage of subjects achieving hemostasis at 3 
minutes using GATT-Patch is 89%, then an evaluable sample size of 36 
evaluable subjects from Stage II achieves over 90% power to demonstrate 
non-inferiority of GATT-Patch compared to current (literature-based) 
knowledge of standard care (i.e., demonstrate that the percentage 
achieving hemostasis at 3 minutes for the population treated with GATT-
Patch is significantly greater than the performance goal of 65.4%) using a 
one-sided continuity corrected Z-test of proportion. The sample size takes 
into account the interim analysis of the primary performance endpoint 
(performed when approximately 69% of the planned evaluable Stage II 
subjects are treated, i.e., n≈25 evaluable Stage II subjects) based on a 
group sequential design to allow for possible early stopping for 
overwhelming performance success. The Lan-DeMets approach5 with an 
O'Brien-Fleming alpha-spending function is used to control the overall 
Type I error rate of the study at a one-sided 0.025 level. 
If the study does not stop for overwhelming performance success at the 
interim review, then an unblinded conditional power calculation and 
sample size re-estimation will also be conducted at the interim review. The 
sample size re-estimation analysis will be performed by an independent 
statistician according to the Mehta-Pocock Promising Zone6 approach. The 
conditional power for demonstrating that the primary performance 
endpoint is significantly greater than performance goal of 65.4% will be 
calculated under the current protocol-specified evaluable sample size, 
under the assumption that the observed interim treatment effect (i.e., 
percentage achieving hemostasis at 3 minutes) is the true treatment effect 
size. If the conditional power under the protocol-specified evaluable 
sample size is between 39% to <90% (the promising zone), then the 
 
5 Lan KKG, DeMets DL. Discrete Sequential Boundaries for Clinical Trials. Biometrika. 1983; 70, 659–663. 
6 Mehta C, Pocock S. Adaptive increase in sample size when interim results are promising: a practical guide with 
examples. Stat Med. 2011;30:3267–84.  
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evaluable sample size may increase to maintain conditional power of 90%. 
The sample size may increase to a maximum of 56 (i.e., up to 20 additional) 
evaluable subjects for Stage II. Such a sample size increase based on the 
Mehta-Pocock Promising Zone approach will not require an additional 
penalty to the final significance (alpha) level. 
The performance goal was established on a systematic literature review 
and meta-analysis, that found the lower 95% confidence interval of the 
random-effects meta-analytical estimate of the percentage achieving 
hemostasis at 3 min to be 65.4%, based on previous studies for hemostatic 
techniques used in open liver surgery.  The assumption of the true rate of 
hemostasis at 3 minutes being 89% for GATT-Patch is based on the pre-
clinical evidence and clinical judgement.  
Intraoperative eligibility after informed consent is estimated at 50%, 
where the other 50% of patients will have no bleeding requiring device 
use. In case this 50% is an underestimate of intraoperative inclusion, there 
is a limitation of replacement that is set at 153 patients, representing a 
rate of 25% of patients being able to be included intraoperatively. 
Inclusion criteria  
A subject must meet all of the following pre-operative inclusion criteria to 
be enrolled into the investigation:  
• 
Subject is scheduled to undergo an elective open surgery on the 
liver;  
• 
Subject is willing and able to give written informed consent for 
investigation participation;  
• 
Subject is 18 years of age or older at the time of enrollment;  
• 
Subject has been informed of the nature of the clinical 
investigation.  
A subject must meet all of the following intraoperative inclusion criteria to 
be treated with the investigational device:  
• 
Subject in whom the Investigator is able to identify a target 
bleeding site at the liver resection plane for which any applicable 
conventional means for hemostasis (e.g. suture, ligature or 
cautery) are ineffective or impractical and the choice is made to 
use a topical hemostat for control of hemostasis;  
• 
Subject has a target bleeding site with a SBSS of 1, 2, or 3.  
Exclusion criteria  
A subject must not meet any of the following pre-operative exclusion 
criteria to be enrolled into the clinical investigation:  
• 
Subject is scheduled to undergo surgery on other organs besides 
the liver (e.g. pancreas, colon, lungs); 
• 
Subject is taking multiple antithrombotic therapies in therapeutic 
dosage up to the time of surgery, allowing exclusive use of 
acetylsalicylic acid; 
• 
Subject has platelet count <100 x 109/L, an activates partial 
thrombin time of >100s, or international normalized ratio >2.5; 
• 
Subject is pregnant, planning on becoming pregnant or actively 
breast-feeding during the follow-up period;  
• 
Subject has a known hypersensitivity to brilliant blue (FD&C Blue 
#1);  
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• 
Subject has an active or suspected infection at the surgical site;  
• 
Subject has a total bilirubin level of ≥ 2.5 mg/dl   
• 
Subject has had or has planned to receive any organ 
transplantation;  
• 
Subject has American Society of Anesthesiologists (ASA) 
classification of 4/5;  
• 
Subject has a life expectancy of less than 3 months;  
• 
Subject has a documented severe congenital or acquired 
immunodeficiency;  
• 
Subject in whom the investigational device will be used at the site 
of a synthetic graft or patch implant;  
• 
Subject is currently participating or has participated in another 
clinical investigation within the past 30 days that may affect the 
endpoints of the study, such as trials related to the surgical 
procedure, and on anti-coagulation;   
• 
Subject is not appropriate for inclusion in the clinical 
investigation, per the medical opinion of the Investigator;  
• 
Subject has any incidental (pre- and peri-operative) findings 
deemed by the Investigator to potentially jeopardize the safety or 
welfare of the patient.  
Statistical analysis   
Analysis sets  
• 
Full Analysis Set (FAS): The FAS population will consist of all Stage 
II treated subjects. This population will be utilized as a primary 
analysis population for the primary and secondary performance 
endpoints and exploratory endpoints.  
• 
Per Protocol (PP): The PP population will consist of FAS subjects 
who do not have major protocol deviations with data analyzed 
according to treatment received. This population will be utilized 
as a secondary analysis population for the primary and secondary 
performance endpoints and exploratory endpoints. Major 
protocol deviations are defined in Section 9 of the protocol.   
• 
Safety Population: The Safety analysis population will consist of 
Stage I and Stage II treated subjects. This population will be 
utilized as the primary analysis population for the safety analyses. 
Summaries will be presented by study stage and overall.   
Statistical design  
Descriptive statistics will be presented for each variable. Continuous 
variables will be summarized using descriptive statistics (number of 
subjects, mean, median, quartiles, standard deviation, minimum, and 
maximum). Categorical variables will be summarized using frequencies 
and percentages of subjects in each category.  
 
This study utilizes an adaptive design with an interim analysis planned for 
the purposes of stopping the trial early for overwhelming performance 
success and for sample size re-estimation.  
  
The interim analysis will be performed once approximately 69% (n≈25) of 
the planned evaluable Stage II subjects are treated. To account for multiple 
testing and control the overall Type I error rate of the study at one-sided 
0.025 level, a group-sequential design will be used based on the Lan-
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DeMets approach with an O'Brien-Fleming alpha-spending function. Based 
on this method, the performance goal of 65.4% for the primary 
performance endpoint will be assessed at the interim review using the 
continuity corrected Z-test of proportion at a one-sided 0.0070 significance 
level. If the statistical analysis of the primary endpoint at the interim 
review yields a one-sided p-value less than 0.0070, then the DMC may 
recommend stopping the trial for overwhelming successful performance. 
If the one-sided p-value is not less than 0.0070, then the study will 
continue and the performance goal of 65.4% for the primary performance 
endpoint will be assessed using the continuity corrected Z-test of 
proportion at the one-sided 0.0229 significance level for the final analysis. 
A sample size increase based on the Mehta-Pocock Promising Zone 
approach will not require an additional penalty to the final significance 
(alpha) level. The primary analysis of the primary performance endpoint 
will be on the FAS with available data. The primary performance endpoint 
will also be analyzed on the PP population as a secondary analysis. 
 
Safety analyses will be descriptive and narrative in nature, including 
definitions of severity and relation for all adverse events, and focusing on 
serious adverse events.  
 
 
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TABLE OF CONTENTS 
 
SPONSOR SIGNATURE PAGE ....................................................................................................................... 2 
INVESTIGATOR SIGNATURE PAGE ............................................................................................................... 3 
CONTACT INFORMATION SHEET ................................................................................................................. 4 
SYNOPSIS................................................................................................................................................... 5 
TABLE OF CONTENTS ................................................................................................................................ 12 
LIST OF TABLES ........................................................................................................................................ 15 
LIST OF FIGURES ....................................................................................................................................... 15 
ABBREVIATIONS AND ACRONYMS ............................................................................................................ 15 
REVISION HISTORY ................................................................................................................................... 16 
1. 
INTRODUCTION ............................................................................................................................... 17 
1.1. 
BACKGROUND ...........................................................................................................................................17 
1.2. 
ROLES AND RESPONSIBILITY .........................................................................................................................17 
2. 
INVESTIGATIONAL DEVICE ................................................................................................................ 19 
2.1. 
MANUFACTURER .......................................................................................................................................19 
2.2. 
GATT-PATCH ...........................................................................................................................................19 
2.2.1. 
Regulatory Classification .............................................................................................................20 
2.2.2. 
Materials ......................................................................................................................................20 
2.3. 
INTENDED POPULATIONS AND INDICATIONS ....................................................................................................20 
2.3.1. 
Intended indications ....................................................................................................................20 
2.3.2. 
Intended populations ...................................................................................................................20 
2.4. 
INTENDED PURPOSE IN THE CLINICAL INVESTIGATION ........................................................................................21 
2.5. 
TECHNICAL AND FUNCTIONAL FEATURES .........................................................................................................21 
2.6. 
MEDICAL/SURGICAL PROCEDURES ................................................................................................................21 
2.7. 
REQUIRED TRAINING AND EXPERIENCE ...........................................................................................................23 
2.7.1. 
Surface Bleeding Severity Scale (SBSS) ........................................................................................23 
2.7.2. 
Investigational Device and Procedure .........................................................................................24 
2.7.3. 
Qualifications ...............................................................................................................................24 
2.8. 
DEVICE TRACEABILITY .................................................................................................................................24 
3. 
JUSTIFICATION FOR CLINICAL INVESTIGATION DESIGN ....................................................................... 25 
3.1. 
PRE-CLINICAL TESTING ................................................................................................................................25 
3.2. 
STATE OF THE ART ......................................................................................................................................25 
3.3. 
CLINICAL DEVELOPMENT STAGE ....................................................................................................................26 
3.4. 
JUSTIFICATION ...........................................................................................................................................27 
4. 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE, CLINICAL PROCEDURE AND CLINICAL 
INVESTIGATION ....................................................................................................................................... 28 
4.1. 
ANTICIPATED CLINICAL BENEFITS ...................................................................................................................28 
4.2. 
ANTICIPATED ADVERSE DEVICE EFFECTS & RESIDUAL RISKS .................................................................................28 
4.3. 
RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL INVESTIGATION ..............................................................28 
4.4. 
RISK CONTROL/MITIGATION .........................................................................................................................29 
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4.5. 
BENEFIT-RISK RATIONALE ............................................................................................................................29 
5. 
OBJECTIVES, HYPOTHESES AND ENDPOINTS ...................................................................................... 30 
5.1. 
PRIMARY OBJECTIVE & HYPOTHESIS ...............................................................................................................30 
5.2. 
PRIMARY ENDPOINT ...................................................................................................................................30 
5.3. 
SECONDARY OBJECTIVES & HYPOTHESES.........................................................................................................30 
5.4. 
SAFETY OBJECTIVE AND SAFETY ENDPOINTS .....................................................................................................30 
5.5. 
EXPLORATORY ENDPOINTS ...........................................................................................................................31 
5.6. 
RATIONALE FOR ENDPOINT SELECTION ...........................................................................................................31 
6. 
DESIGN OF THE CLINICAL INVESTIGATION ......................................................................................... 32 
6.1. 
GENERAL..................................................................................................................................................32 
6.2. 
INVESTIGATIONAL DEVICE AND COMPARATORS ................................................................................................32 
6.3. 
SUBJECTS .................................................................................................................................................32 
6.3.1. 
Inclusion criteria ...........................................................................................................................32 
6.3.2. 
Exclusion criteria ..........................................................................................................................33 
6.3.3. 
Representativeness of included population .................................................................................33 
6.3.4. 
Definition of enrollment ...............................................................................................................33 
6.3.5. 
Randomization .............................................................................................................................33 
6.3.6. 
Sample size...................................................................................................................................34 
6.3.7. 
Study duration .............................................................................................................................34 
6.3.8. 
Subject withdrawal, discontinuation and study end ...................................................................34 
6.3.9. 
Subject replacement ....................................................................................................................34 
6.3.10. 
Investigational sites .....................................................................................................................35 
6.4. 
PROCEDURES ............................................................................................................................................35 
6.4.1. 
Schedule of assessments ..............................................................................................................35 
6.4.2. 
Equipment for assessment ...........................................................................................................36 
6.4.3. 
Screening......................................................................................................................................36 
6.4.4. 
Admission before surgery ............................................................................................................37 
6.4.5. 
Treatment ....................................................................................................................................37 
6.4.6. 
Hospitalization after surgery .......................................................................................................38 
6.4.7. 
Visit 1 (Week 6) ............................................................................................................................38 
6.4.8. 
Study completion .........................................................................................................................39 
6.4.9. 
Activities by Sponsor representatives ..........................................................................................39 
6.5. 
MINIMIZATION OF BIAS ...............................................................................................................................39 
6.6. 
POTENTIAL CONFOUNDING FACTORS .............................................................................................................39 
6.7. 
SCIENTIFIC ROBUSTNESS ..............................................................................................................................39 
6.8. 
MONITORING PLAN ....................................................................................................................................39 
7. 
STATISTICAL CONSIDERATIONS ......................................................................................................... 40 
7.1. 
STATISTICAL DESIGN & METHODS..................................................................................................................40 
7.1.1. 
Primary endpoint analysis ...........................................................................................................40 
7.1.2. 
Secondary endpoint analysis .......................................................................................................41 
7.1.3. 
Safety endpoints ..........................................................................................................................41 
7.1.4. 
Exploratory Endpoints ..................................................................................................................41 
7.2. 
SAMPLE SIZE .............................................................................................................................................42 
7.3. 
ANALYSIS POPULATIONS ..............................................................................................................................43 
7.4. 
MISSING DATA ..........................................................................................................................................43 
7.5. 
LEARNING CURVE .......................................................................................................................................43 
7.6. 
INTERIM ANALYSIS......................................................................................................................................43 
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7.7. 
STATISTICAL DEVIATIONS .............................................................................................................................44 
7.8. 
MANAGEMENT OF BIAS...............................................................................................................................44 
7.9. 
POOLED DATA ...........................................................................................................................................45 
8. 
DATA MANAGEMENT ....................................................................................................................... 46 
8.1. 
DATA ENTRY AND COLLECTION......................................................................................................................46 
8.2. 
DATA REVIEW, DATABASE CLEANING, AND ISSUING AND RESOLVING DATA QUERIES ................................................46 
8.3. 
PROCEDURES FOR VERIFICATION, VALIDATION AND SECURING OF ELECTRONIC CLINICAL DATA SYSTEMS ......................46 
8.4. 
CASE REPORT FORMS ..................................................................................................................................47 
8.5. 
DATA RETENTION .......................................................................................................................................47 
8.6. 
SUBJECT CONFIDENTIALITY ...........................................................................................................................47 
8.7. 
DATA PROTECTION .....................................................................................................................................47 
8.8. 
OTHER ASPECTS OF CLINICAL QUALITY ASSURANCE ...........................................................................................48 
8.8.1. 
Monitoring ...................................................................................................................................48 
8.9. 
SAMPLE RETENTION ...................................................................................................................................48 
9. 
AMENDMENTS, DEVIATIONS & WAIVERS .......................................................................................... 49 
9.1. 
AMENDMENTS ..........................................................................................................................................49 
9.2. 
DEVIATIONS AND WAIVERS .........................................................................................................................49 
9.2.1. 
Reporting .....................................................................................................................................49 
9.2.2. 
Corrective and preventive actions ...............................................................................................49 
9.2.3. 
Investigator disqualification criteria ............................................................................................49 
9.2.4. 
Follow-up management ...............................................................................................................50 
10. 
DEVICE ACCOUNTABILITY ............................................................................................................. 51 
11. 
STATEMENTS OF COMPLIANCE ..................................................................................................... 52 
12. 
INFORMED CONSENT PROCESS ..................................................................................................... 53 
13. 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES ........................................ 54 
13.1. 
DEFINITIONS .............................................................................................................................................54 
13.1.1. 
Adverse events .............................................................................................................................54 
13.1.2. 
Serious adverse event ..................................................................................................................54 
13.1.3. 
Device deficiency ..........................................................................................................................54 
13.1.4. 
Adverse device effect ...................................................................................................................54 
13.1.5. 
Serious adverse device effect .......................................................................................................55 
13.1.6. 
Unanticipated serious adverse device effect ...............................................................................55 
13.1.7. 
Anticipated serious adverse device effect....................................................................................55 
13.2. 
CAUSALITY................................................................................................................................................55 
13.3. 
SEVERITY ..................................................................................................................................................57 
13.4. 
FORESEEABLE ADVERSE EVENTS AND ANTICIPATED ADVERSE DEVICE EFFECTS .........................................................57 
13.5. 
NON-REPORTABLE ADVERSE EVENTS ..............................................................................................................58 
13.6. 
REPORTING REQUIREMENTS .........................................................................................................................58 
13.6.1. 
Reporting adverse events ............................................................................................................58 
13.6.2. 
Reporting device deficiencies .......................................................................................................58 
13.6.3. 
Reporting serious adverse events and serious adverse device effects ........................................58 
13.7. 
MEDICAL MONITOR ....................................................................................................................................60 
13.8. 
DATA MONITORING COMMITTEE...................................................................................................................60 
14. 
VULNERABLE POPULATION ........................................................................................................... 61 
15. 
SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION ............................. 61 
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15.1. 
STOPPING RULES .......................................................................................................................................61 
16. 
PUBLICATION POLICY ................................................................................................................... 61 
17. 
BIBLIOGRAPHY ............................................................................................................................. 62 
 
LIST OF TABLES 
Table 1. Raw materials/chemical components GATT-Patch .................................................................20 
Table 2. Alternative Hemostatic (and Sealing) Agents ..........................................................................25 
Table 3: Summary of Primary Endpoint Outcome reported in Scientific Literature and Used in Sample 
Size Calculation ......................................................................................................................................31 
Table 4: Schedule of Assessments .........................................................................................................35 
Table 5: Laboratory testing schedule ....................................................................................................36 
 
LIST OF FIGURES 
Figure 2-1. GATT-Patch ..........................................................................................................................19 
Figure 2-2: GATT application flowchart .................................................................................................23 
Figure 2-3: GATT-Patch Training FlowChart ..........................................................................................24 
 
ABBREVIATIONS AND ACRONYMS 
ADE 
 
Adverse Device Effect 
AE 
 
Adverse Event 
ASADE  
Anticipated Adverse Device Effect  
CI 
 
Confidence Interval 
CRF 
 
Case Report Form 
CRO 
 
Contract Research Organization 
DMC 
 
Data Monitoring Committee 
eCRF 
 
Electronic Case Report Form 
EDC 
 
Electronic Data Capture 
IFU 
 
Instructions for Use 
ISO14155 
International Standard on the Clinical investigation of medical devices for human 
subjects — Good clinical practice 
PI 
 
Principal Investigator 
SADE 
 
Serious Adverse Device Effect 
SAE 
 
Serious Adverse Event 
SAP 
 
Statistical Analysis Plan 
SBSS 
 
Surface Bleeding Severity Score 
UADE  
Unanticipated Adverse Device Effect 
USADE  
Unanticipated Serious Adverse Device Effect 
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REVISION HISTORY  
Version  
Date 
Summary of Changes/Affected Sections 
Version 01 
14/DEC/2020 
N/A – Initial Version 
Version 02 
21/JAN/2021 
• 
Clarification on the statistical considerations  
• 
Clarification on the limitation of subject replacement  
• 
Addition of collecting photo and video material for training purposes 
Version 03 
09/MAR/2021 
• 
Readdressing the use of Stage I data (safety analysis only) and 
associated analysis population definitions.  
• 
Limitation of number of sites in Stage I (max 3 sites), and minimum 
number of subjects per site in Stage I (min 2 subjects).  
• 
Removal of secondary endpoint for superiority of GATT-Patch in 
achieving hemostasis at 3 minutes.  
• 
Implementation of an adaptive design, i.e. an interim sample size re-
estimation based on performance success.  
• 
Reference to Surface Bleeding Severity Score (SBSS) instead of SPOT 
GRADE.  
• 
Implementation of a maximum number of intraoperative screening 
failures.  
• 
Revision of several eligibility criteria.  
• 
Revision of the surgical procedure language, to align with revised 
Instructions for Use, and addition of detailed procedures in case 
hemostasis is not achieved after an initial 30 seconds application time.  
• 
Revision of the investigational device training requirements, including 
the option of proctoring by principal investigator or experienced 
investigators.  
• 
Revision of anticipated adverse device effects & residual risk language, 
to align with Risk Management Report.  
• 
Addition of overview of required laboratory testing, assessments at 
admission before surgery, and during hospitalization after surgery.  
• 
Minor formatting and language edits.  
Version 04 
28/APR/2021 
• 
Revision and alignment of ASA score in exclusion criteria to 4/5 
throughout protocol. 
• 
Clarification on Stage I safety analysis; to be performed when all 12 
patients have at least 2 week FU data and not after completion of 6 week 
FU visit. 
• 
Defining treatment failure as ‘no hemostasis after 5 minutes’ instead of 
‘prior to site closure’ to align with rest of protocol and DMC charter. 
• 
Addition of risk for encapsulated or rolled-up device at a lower risk 
level/incidence under foreseeable adverse events and anticipated 
adverse device effects 
• 
Minor formatting and language edits. 
 
 
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1. INTRODUCTION 
1.1. 
Background 
Hepatic surgery, such as liver resection, has been associated with considerable mortality and 
morbidity [2]. The postoperative mortality for major hepatectomy has been reported in a range from 
0.7-2.6% [3]. The short-term and long-term outcomes of open liver surgery may be influenced by 
uncontrolled bleeding during the operation, and a need for blood transfusion [2, 3]. A 2011 
retrospective analysis of approximately 1.6 million surgeries, including cardiac, vascular, solid organ, 
and spinal surgeries, found that the rate of bleeding-related complications was 29.9%, with blood 
transfusions occurring in 21.2% of all patients. There are significant benefits to patients when 
hemostasis is addressed efficiently, and effective treatment of bleeding may reduce blood loss and 
perioperative complications [4].  
During liver surgery, most luminal structures greater than 2mm in diameter are controlled during 
parenchymal transection [5] by temporary occlusion of inflow vessels (e.g., Pringle maneuver to 
control inflow of the portal triad), and control of bleeding from outflow vessels (lowering central 
venous pressure or anterior elevation of the liver to avoid back-bleeding) [5, 6]. After transection, 
small volume bleeding may occur from the cut surface of the future liver remnant. Ligation, or 
electrocautery techniques can be used to control bleeding from visible compromised vessels. Bleeding 
from generalized venous ooze are better controlled with topical hemostatic agents.  
There is a wide variety of topical hemostatic devices, sealants and adhesives available on the market 
and these can generally be divided into products without active components, products that include 
active components that mimic natural coagulation and combined agents. Recently, there has been an 
increase in development of advanced hemostatic pads and patches that can provide hemostasis and 
sealant properties similar to fibrin sealants (e.g., TachoSil) [7]. GATT Technologies BV developed a 
novel hemostatic patch that consists of a gelatin carrier and two synthetic activated polymers (NHS-
POx). GATT-Patch has been developed to provide a fast and robust control of bleeding during surgery. 
The current investigation will be the first-in-human study that will evaluate the safety and the 
performance of GATT-Patch in elective open liver surgery.  
1.2. 
Roles and responsibility 
This clinical investigation is sponsored by GATT Technologies BV (Nijmegen, the Netherlands), the legal 
manufacturer of GATT-Patch.  
GATT Technologies BV contracted Avania BV’s services to assist in organization and the conduct of the 
clinical investigation. Avania is a full-service contract research organization (CRO) for medical devices 
and is responsible for statistics, data management, medical writing, monitoring, and study 
management.  
Investigators at investigational sites will be responsible for patient screening, patient treatment and 
data collection as outlined in this clinical investigation plan (CIP). Each site will have a designated 
principal investigator (PI) and one or more study coordinators collectively responsible for the 
prospective data collection, inclusive of screening, enrollment, evaluation, and documentation, in 
accordance with the International Organization for Standardization (ISO) 14155: Clinical investigation 
of medical devices for human subjects — Good clinical practice guidelines. Per site, one physician will 
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be assigned as PI. Other involved physicians will be referred to as ‘sub-investigators’. Contact details 
of involved investigators will be kept on a separate file. 
The CRO and investigational sites signed a confidentiality agreement to protect the commercial 
interests of the Sponsor. The agreements between the Sponsor and investigators will be outlined in a 
Clinical Trial Agreement. The investigators/investigational sites will receive a financial compensation 
for their participation in the clinical investigation. Financial compensation will be reimbursed through 
the Sponsor. The investigators will disclose other relevant financial compensation in a financial 
disclosure.   
 
 
 
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2. INVESTIGATIONAL DEVICE 
2.1. 
Manufacturer 
GATT Technologies BV (Nijmegen, the Netherlands) is the legal manufacturer of GATT-Patch. 
2.2. 
GATT-Patch 
GATT-Patch (Figure 2-1) is a resorbable hemostatic sealing patch, contained in a sterile blister pack 
within a pouch, for topical use in internal surgery. It does not require freezing or other special storage 
requirements. It presents as a blue, soft, flexible, gelatin fiber-based carrier impregnated with an NHS-
POx / NU-POx granulate. The dimensions of GATT-Patch are 50x100mm. As GATT-Patch is a 
homogenously impregnated fibrous material, both sides are active and it is also suited to being torn 
into smaller pieces for application in irregularly shaped structures and areas that are difficult to access 
with a larger item.  
 
FIGURE 2-1: GATT-PATCH 
GATT-Patch will be applied onto the wound site where the flexible and resorbable gelatin patch via 
contact activation starts the coagulation cascade, further enhanced by dehydrating the blood to 
concentrate the blood’s solid elements leading to a matrix for platelet aggregation and release of 
coagulation factors enabling fibrin formation 'trapped' in the gelatin fibers. Once the patch is 
activated, via the combination of P(EtOx-OH-NHS), P(EtOx-NH2) and gelatin, a POx-hydrogel is formed. 
This POx-hydrogel has two effects: firstly, to adhere the patch to the tissue and secondly to form a 
seal across the damaged tissue. Both parts together help to ensure high efficacy hemostasis can be 
achieved.   
GATT-Patch is a Class III Medical Device intended for application by trained physicians as an aid to 
hemostasis and sealing in internal organs during surgery after standard surgical hemostatic 
techniques have been applied. The effect is local and primarily mechanical and is not dependent on 
the coagulation status of the patient. The product is not removed at the end of surgery but 
is resorbed in 4-6 weeks7.  
 
 
7 The resorption time was estimated 4-6 weeks based on initial preclinical testing of prototypes. The outcomes 
of a recent GLP implantation study on the final design of GATT-Patch shows resorption in <4 weeks. 
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2.2.1. 
Regulatory Classification  
GATT-Patch is indicated for use as an adjunct to hemostasis and as a surgical sealant in surgery for 
minimal, mild or moderate bleeding sites. GATT-Patch is intended to be used for management of 
hemorrhage during surgeries on internal organs. GATT Patch will be totally introduced into the human 
body and intended to remain there after the procedure. It is fully degradable within 4-6 weeks. 
According to classification rule 8 of Annex VIII of the EU MDR 4 April 2017, the device is a long term 
surgically invasive and implantable device. The device will be wholly absorbed and it will undergo a 
chemical change in the body.   
According to classification rule 18 of Annex VIII of the EU MDR 4 April 2017, the device is manufactured 
utilizing derivatives of animal origin, which are non-viable or rendered non-viable.   
Therefore, according to both classification rules, GATT-Patch is classified as a Class III medical device.  
2.2.2. 
Materials 
A listing of the raw materials used in the manufacturing of the final finished P(EtOx-OH-NHS) - P(EtOx-
NH2) granulate-based hemostatic patches is provided in Table 1. GATT-Patch is an implant, and all 
components are in direct contact with the human body. 
TABLE 1: RAW MATERIALS/CHEMICAL COMPONENTS GATT-PATCH  
Device Component  
Raw Materials in 
Component  
Supplier   
CAS Number 
Polymers 
P(EtOx-OH-NHS) polymer   PolyVation  
NA  
P(EtOx-NH2) polymer  
PolyVation  
NA  
Blue Colorant FD&C Blue No. 1  
FD&C Blue No.1  
Spectrum Chem. via VWR  
3844-45-9  
Granulate 
P(EtOx-OH-NHS) and 
P(EtOx-NH2)   
GATT Technologies 
NA 
Porous Gelatin carrier (porcine 
origin)  
Gelatin  
Gelita Medical  
9000-70-8  
2.3. 
Intended populations and indications  
2.3.1. 
Intended indications 
GATT-Patch is indicated for use as an adjunct to hemostasis and as a surgical sealant in surgery for 
minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques 
(such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for 
management of hemorrhage during surgeries on internal organs, primarily parenchymatous 
organs such as liver, spleen or kidney; or in other abdominal surgeries. GATT-Patch is intended to be 
used by physicians trained in performing specific surgical and minimal invasive procedures.  
2.3.2. 
Intended populations  
The 
hemostatic 
sealant 
GATT-Patch 
will 
be 
intended 
for 
use 
in 
adult, 
adolescent and pediatric patients. 
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The final recommendations will depend on pre-clinical and clinical data, as the safety and performance 
of the device has not been yet established for use in specific populations as children, pregnant or 
lactating women.  
It should not be used in patients with a known hypersensitivity to the component materials, including 
porcine proteins and brilliant blue (FD&C Blue No. 1).  
2.4. 
Intended purpose in the clinical investigation 
This clinical investigation focusses on the application of GATT-Patch in subjects that are candidate for 
elective open liver surgery. 
2.5. 
Technical and functional features 
GATT-Patch will be applied to the bleeding site where the flexible and resorbable gelatin patch starts 
the coagulation cascade via contact with tissue. This is further enhanced by dehydrating the blood to 
concentrate the blood’s solid elements leading to a matrix for platelet aggregation and the release of 
coagulation factors enabling fibrin formation 'trapped' in the gelatin fibers. Once the patch is 
activated, via the combination of P(EtOx-OH-NHS), P(EtOx-NH2) and gelatin, a POx-hydrogel is 
formed. This POx-hydrogel has two effects: (1) to adhere the patch to the tissue and (2) to form a seal 
across the damaged tissue. Together, these two effects help ensure highly effective hemostasis can 
be achieved independent of the patient’s coagulation status, and that the tissue surface remains 
sealed, preventing leakage of fluids. The patch is resorbed within 4-6 weeks as tissue healing occurs. 
The following technical and functional features are defined for GATT-Patch:  
• 
GATT-Patch is a highly active, fibrous, flexible, blue-colored gelatin fiber-based patch that is 
homogeneously impregnated with an NHS-POx/NU-POx granulate for topical use during 
internal surgery.  
• 
GATT-Patch can be stored at room temperature and can be used straight out of the package 
without preparation time.  
• 
The results of preclinical tests have demonstrated that hemostasis could be obtained with 30 
seconds of application time 
• 
A flexible and pliable patch of 100 x 50mm size that can easily be cut to smaller size  
• 
Active on both sides  
• 
The patch is resorbed within 4-6 weeks as tissue healing occurs as demonstrated by a GLP 
implantation study 
2.6. 
Medical/Surgical procedures 
The severity of bleeding will be scored according to the Surface Bleeding Severity Scale (SBSS) [1]. 
Select the appropriate size of the patch so that it overlaps the margins of the bleeding surface by at 
least 1 cm. The patch may be cut to the desired size and shape. Dry gloves and surgical instruments 
(forceps, scissors) should be used to handle, cut and apply GATT-Patch.   
Surgeons may use up to three patches, or multiple (cut) parts of patches, as long as total material used 
is no more than three full patches in total in the patient. Patch may be applied to or overlap a 
previously applied patch (“patch on patch”). If hemostasis has not been achieved after using three 
patches, other hemostatic agents/techniques may be used. 
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The following method of application is provided in the instructions for use of GATT-Patch (DHF-01-
QR-008):  
• 
Put GATT-Patch on a saline wetted gauze or surgical sponge and apply to the bleeding area, 
with at least 1 cm margins. Hold in place with uniform pressure over the entire patch surface 
for 30 seconds. Gently remove the wet gauze from the patch. If complete hemostasis has not 
been achieved in 30 seconds, re-apply pressure with a saline wetted gauze or surgical sponge 
for an additional 30 seconds;  
o If hemostasis is not complete with a single patch and blood comes through the patch, 
apply a new (piece of) GATT-Patch on the bleeding site with a 1cm overlap with tissue 
or previously placed GATT-Patch on all sides ("patch-on-patch"). Apply according to 
the steps above.  
o If hemostasis is not complete because GATT-Patch is not adherent to the underlying 
tissue, with or without hematoma formation underneath, remove the non-adherent 
part and apply a new (piece of) GATT-Patch on the bleeding site with a 1cm overlap 
with tissue or previously placed GATT-Patch on all sides ("patch-on-patch"). Apply 
according to the steps above.  
o Repeat the above steps as necessary, with a maximum of 2.1 cm2 / kg of patient body 
weight, or approximately 3 patches in a normal adult patient, is covered by GATT-
Patch and remains in-situ at the end of the operation.  
• 
It is recommended that dry parts of GATT-Patch after application are wetted via a saline-
soaked wet gauze or by irrigation.  
• 
When applying GATT-Patch, minimize contact with wet or bloody surgical instruments or 
gloves as the adhesive may adhere to other surfaces.  
• 
Leave GATT-Patch in situ after hemostasis has been achieved. Do not try to forcefully remove 
the patch.  
• 
Do not remove GATT-Patch at the end of the surgery. Excess GATT-Patch material may be 
removed carefully, at the discretion of the surgeon.  
• 
Irrigate GATT-Patch after application and hemostasis, assess potential re-bleedings prior to 
closing the laparotomy.  
It is recommended to use the product within 3 hours after opening (after 3 hours, the performance of 
the device may decrease). To ensure adequate endpoint assessment in this clinical investigation, no 
manipulation of GATT-Patch and the Target Bleeding Site should be performed up to 5 minutes after 
GATT-Patch application, unless extra pressure or an additional patch is required per instructions for 
use and scenarios below. 
As described in the IFU, certain situations can occur in which hemostasis is not achieved after an initial 
30 seconds application time. The following description, and Figure 2-2, provide more details: 
• 
Hemostasis is achieved (SBSS 0) but blood builds up underneath GATT-Patch as shown by a 
dome formation (e.g. caused by inadequate pressure) 
 re-apply 30 seconds of pressure. If 
after an additional 30 seconds of pressure a dome again arises, cut away the dome and apply 
a new (piece of) GATT-Patch on the bleeding site with a 1cm overlap with tissue or previously 
placed GATT-Patch on all sides. Apply pressure for 30 seconds. Repeat as necessary up to 5 
minutes. If hemostasis is achieved (SBSS 0) and GATT-Patch is adhesive to the tissue 
 leave 
GATT-Patch in place and do not manipulate until 5 minutes from the initial application have 
passed. 
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• 
Hemostasis is not achieved (SBSS ≥1) because GATT-Patch is not adherent to underlying tissue 
(e.g. caused by inadequate pressure) 
 re-apply 30 seconds of pressure. If after an additional 
30 seconds of pressure (a part of) GATT-Patch is not adherent, cut away the non-adherent 
part and apply a new (piece of) GATT-Patch on the bleeding site with a 1cm overlap with tissue 
or previously placed GATT-Patch on all sides. Apply pressure for 30 seconds. Repeat as 
necessary up to 5 minutes. If hemostasis is achieved (SBSS 0) and GATT-Patch is adhesive to 
the tissue 
 leave GATT-Patch in place and do not manipulate until 5 minutes from the initial 
application have passed. 
• 
Hemostasis is not achieved as blood is coming through GATT-Patch (SBSS ≥1) 
 re-apply 30 
seconds of pressure. If after an additional 30 seconds of pressure blood is still coming through 
the patch (e.g. potential cause is puncture of the patch), apply an additional (piece of) GATT-
Patch on the bleeding site (e.g. “patch-on-patch”) with a 1cm overlap on the previously placed 
GATT-Patch on all sides. Apply pressure for 30 seconds. Repeat as necessary up to 5 minutes. 
If hemostasis is achieved (SBSS 0) and GATT-Patch is adhesive to the tissue 
 leave GATT-
Patch in place and do not manipulate until 5 minutes from the initial application have passed. 
 
FIGURE 2-2: GATT APPLICATION FLOWCHART 
2.7. 
Required training and experience 
On-site initiation visits will be organized, in which full training will be given to all appropriate staff 
members participating in the clinical investigation, including principal investigators, study 
coordinators and any other site personnel pivotal to the conduct of the clinical investigation. This 
training will include at least the following: instructions on the functions and use of the investigational 
device by the Sponsor, training on SBSS for assessment of bleeding at the target site, procedures 
outlined in the clinical investigation plan, main principles of Good Clinical Practices for Medical Devices 
(ISO 14155), instructions on completion of the case report forms, content of the investigator site file, 
and management of device deficiencies. 
2.7.1. 
Surface Bleeding Severity Scale (SBSS) 
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The investigators at each site will have training on the SBSS prior to the enrollment of any subjects. 
Training will be in conformity with the certified e-learning training set up by the SBSS developer and 
owner [1]. Training on the SBSS will be performed to reduce intra-rater variability in the assessment 
of bleeding at the target site. A training record will be signed on completion of the training and filed 
in the TMF. 
2.7.2. 
Investigational Device and Procedure 
All investigators will have extensive training on the investigational device prior to the start to reduce 
a potential influence of a learning curve in using the device on outcome. A training record on the 
investigational device training will be signed on completion of the training and filed in the TMF. The 
principal investigator will get acquainted with use of the device during implantation in animals, after 
which they can use GATT-Patch on trial subjects. Each additional surgeon that has not yet used GATT-
Patch will be proctored by the principal investigator or an experienced investigator that has previously 
used GATT-Patch at least once. The flow of training by proctoring is further explained in Figure 2-3. A 
training record for the proctoring session will be signed on completion of the training and filed in the 
TMF.  
 
FIGURE 2-3: GATT-PATCH TRAINING FLOWCHART 
PI = principal investigator; numbers reflect additional surgeons performing surgery with GATT-Patch 
2.7.3. 
Qualifications 
The investigators will have adequate qualifications with regards to the following:  
• 
trained on use of GATT-Patch; 
• 
trained on the SBSS; 
• 
trained in performing specific surgical procedures; 
• 
experience and training in clinical studies, particularly clinical studies involving medical 
devices, and Good Clinical Practices for Medical Devices (ISO 14155);  
• 
able to read and understand English. 
2.8. 
Device traceability 
Investigational devices used in this clinical investigation will be labelled with a unique LOT number. 
The unique LOT allows for identification and tracking of devices throughout the clinical investigation. 
The devices will be labelled with the text “Exclusively for Clinical Investigation” to avoid non approved 
use of the device. Further details are provided in Section 10. In addition, the patient card further 
ensures the identification of the device and continued traceability after study termination.  
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3. JUSTIFICATION FOR CLINICAL INVESTIGATION DESIGN 
3.1. 
Pre-clinical testing 
GATT Technologies BV performed pre-clinical testing to assess residual risks associated with the 
device. Details on pre-clinical testing are provided in the Investigator Brochure (DHF-01-SFT-164). 
Design verification and validation was performed in accordance with national and international 
standards. The outcomes of the pre-clinical tests demonstrated that the device performs as intended 
and is safe for use in humans.  
3.2. 
State of the art  
This first-in-human clinical investigation will generate the first clinical data for GATT-Patch. A literature 
review was performed to establish clinical evidence referring to the clinical safety and performance, 
and associated risks and benefits of GATT-Patch (Literature Review Protocol Version 01, 24 September 
2020). The objective was to identify comprehensive and up-to-date information on established 
therapies, the safety and performance of state-of-the-art treatments and/or devices, methods to 
assess effectiveness, and known adverse events that are related to the management of hemorrhage 
during liver surgery. Relevant outcomes included adverse events, device deficiencies, study 
population (eligibility criteria), primary effectiveness/performance and safety outcome measures and 
secondary outcome measures. Overall, data obtained through the literature review was used to 
provide input to the assessment of acceptable benefit/risk profiles of GATT-Patch and to determine 
the performance goal for the proposed clinical investigation on GATT-Patch. A summary is provided 
below. Detailed results are provided in a Literature Review Report (DHF-01-SFT-166, Version 01).  
There are numerous hemostasis and sealing products approved for bleeding during surgery (Table 2). 
This includes both biological and synthetic products as well as patches and non-patches. These 
products have different modes of action based on their composition, but despite differences in 
composition and formation (patch vs non-patch), many of these products have a similar indication as 
adjunct to hemostasis. These products are thus relevant to consider as alternatives to GATT-Patch.  
For the risk management activities, specific alternative patches that are approved for hemostasis in 
Europe, such as TachoSil, Veriset, and HEMOPATCH and that have a similar mode of action and 
intended use as GATT-Patch were used to provide input in the risk profile of GATT-Patch. The clinical 
evaluation will further elaborate on current alternative treatment options that have the same 
indication as GATT-Patch.  
TABLE 2: ALTERNATIVE HEMOSTATIC (AND SEALING) AGENTS 
Group 
Category 
Class 
Hemostats 
Mechanical 
Porcine gelatin 
Bovine collagen 
Oxidized Regenerated Cellulose (ORC) 
Active 
Bovine thrombin 
Human-pooled plasma thrombin 
rhThrombin 
Combined 
Porcine gelatin + thrombin 
Bovine gelatin and human-pooled plasma thrombin 
Hemostatic 
Sealants 
Fibrin Sealants 
Human plasma and human thrombin 
Human-pooled plasma and bovine thrombin 
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Group 
Category 
Class 
Individual human plasma, bovine collagen and bovine thrombin 
Human-pooled plasma and equine collagen 
Synthetic sealants, 
PEG-based 
Two PEGs 
PEG, trilysine amine and FD&C blue #1 
PEG and human serum albumin 
Albumin 
and 
glutaraldehyde 
Bovine serum albumin and 10% glutaraldehyde 
 
In general, topical hemostatic agents have been found effective to control bleeding at bleeding sites 
that include raw diffuse bleedings and that are difficult to control using traditional hemostatic 
techniques [2, 3]. GATT-Patch is intended to provide fast and persistent control of bleeding during 
surgeries on internal organs, as well as robust adhesion and sealing. When compared to other 
hemostatic agents that are considered standard of care or when compared to benchmark devices, it 
is expected that GATT-Patch will provide at least the same rate of hemostasis but faster and with 
improved adhesion for a prolonged benefit. The flexibility and pliability of GATT-Patch allows it to be 
used in a variety of clinical situations where current standard-of-care patch products are impractical 
for use. Furthermore, the composition and mode of action of GATT-Patch differentiates from currently 
approved products and thereby addresses the medical need of a combination of quick hemostasis, 
persistent hemostasis, and strong adhesion and tissue sealing. 
The risks of GATT-Patch are considered similar to other hemostasis and sealing devices used during 
liver surgery (patch and non-patch). There is low risk of adverse events associated with topical 
hemostatic agents [3]. Device-related adverse events (AEs) that were identified for benchmark devices 
(devices with similar properties and the same intended use as GATT-Patch) occurred with a low 
incidence rate: 0-18.2%, with 18.2% being a reported imbalance in treatment assignment to two 
investigators, who had a different interpretation of causal events than other investigators. If not taken 
into account, device-related AE occurred in a range of 0-6.7% and included the risk of bile leak, 
hematoma, anemia, diarrhea hypomagnesemia, localized intra-abdominal fluid collection, nausea, 
peritoneal abscess, pleural effusion, infectious peritonitis, liver abscess, postoperative abscess, post-
operative adhesion and procedural hemorrhage. There is no risk of immunogenicity. One device-
related event of increased C-reactive protein was identified (1.8%) but was not considered non-
serious.  
The present clinical investigation is intended to investigate whether the device is safe and performs 
as intended when compared to the state of the art. It is hypothesized that (1) a high rate of hemostasis, 
(2) a short time to hemostasis, and (3) persistent hemostasis results in less intraoperative and 
postoperative risk to patients undergoing these surgeries.  
3.3. 
Clinical development stage  
This clinical investigation is intended to collect clinical safety and performance data for CE-mark of the 
device in Europe. In addition, the results will be used for the design of an investigational device 
exemption (IDE) trial and commercialization in the US. 
 
 
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3.4. 
Justification 
Clinical data from competitor devices and standard of care treatment for open liver surgery were 
reviewed and were used to predict safety and performance outcomes of GATT-Patch and to create 
appropriate preventive measures for possible risks associated with the device. All residual risks for 
GATT-Patch have been assessed and reduced to an acceptable or tolerable level. The clinical 
investigation is performed to evaluate clinical safety and performance of the device for use in open 
liver surgery. The primary objective is to meet the general safety and performance requirements for 
GATT-Patch as intended for its CE marking in Europe as they relate to safety and performance and 
acceptability of the benefit-risk profile.  
 
 
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4. RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE, CLINICAL 
PROCEDURE AND CLINICAL INVESTIGATION 
4.1. 
Anticipated clinical benefits 
The intended clinical benefit of GATT-Patch is to provide fast and persistent hemostasis during 
surgeries on internal organs, primarily parenchymatous organs such as liver, spleen or 
kidney; or in other abdominal surgeries. It is hypothesized that a high rate of fast and persistent 
hemostasis may result in less clinical risk of complications to patients undergoing these surgeries.  
4.2. 
Anticipated adverse device effects & residual risks  
Possible risks for GATT-Patch were assessed and controlled using the EN-ISO 14971 “Medical devices 
– application of risk management to medical devices”. The results of the risk management are 
recorded in the risk management report (DHF-SFT-121). According to the results of the use risk 
assessment, the following risks are judged as ‘tolerable and improbable to occur’, as ‘tolerable and 
remote to occur’, or ‘tolerable and occasional to occur’:  
• 
Toxic response  
• 
Thromboembolic event  
• 
(Re)Bleeding  
• 
Allergic reaction  
• 
Pain  
• 
New surgery  
• 
Infection  
• 
Blockage of artery or vein / ischemia of organs  
• 
Damage of organs and vessels 
• 
Pulsatile hematoma  
• 
Closing of intestinal track  
• 
Biloma 
Furthermore, the risk for encapsulated or rolled-up device was identified during the risk management, 
at a lower risk level/incidence. This risk will be further investigated in this clinical investigation by 
means of the 6-weeks follow-up imaging.   
There were no risks identified as ‘probable’ or ‘frequent’ to occur, neither at a ‘not acceptable’ risk 
level.   
Note: these events can be considered procedure- or device-related events. Adjudication will be based 
on the definitions provided in Section 13. 
4.3. 
Risks associated with participation in the clinical investigation 
The risks that are anticipated for participation in the clinical investigation are:  
• 
Anticipated adverse device effect for the use of GATT-Patch as provided in Section 4.2. 
• 
Procedure-related adverse events during open liver surgery similar to the standard of care.  
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4.4. 
Risk control/mitigation  
GATT Technologies BV performed risk analysis in accordance with EN ISO 14971:2019. All residual risks 
have been controlled and are mitigated to an acceptable level. Careful definitions of specific eligibility 
criteria, study procedures and instructions for use (DHF-01-QR-008), appropriate selection, 
qualification and training of the investigators, and patient follow-up procedures have been designed 
as to further contribute to reduce risks as far as possible for the patient and residual risk acceptance. 
For the purpose of risk control and mitigation during the conduct of the study the clinical investigation 
will be split into 2 stages:  
• 
Stage I of the clinical investigation will enroll a small cohort of subjects within which the initial 
safety of GATT-Patch will be evaluated. A maximum of 12 subjects (~25% of the overall 
population) will be treated8 at a maximum of 3 sites, after which the enrollment into the 
clinical investigation will be paused. At minimum, 2 subjects shall be treated per site. 
• 
Stage II of the clinical investigation will enroll subjects until 39* Stage II subjects have been 
treated with the investigational device. (*Note: The number of Stage II subjects may increase 
to a maximum of 61 treated subjects [56 evaluable Stage II subjects, assuming 7.5% drop-out 
rate] if a sample size increase is deemed necessary based on the interim sample size re-
estimation).  Stage II will be used to evaluate safety and performance of GATT-Patch.  
Furthermore, potential risks associated with participation in this investigation will be minimized and 
managed in accordance with ISO 14155, and requirements of the approving Ethics Committee(s).  
4.5. 
Benefit-risk rationale 
GATT Technologies BV believes that any potential risk presented by this clinical investigation has been 
minimized and that adequate testing, safeguards, and safety monitoring have been incorporated into 
the clinical investigation to further minimize and mitigate the risks. GATT Technologies BV believes 
that the benefits of GATT-Patch outweigh the potential risks posed to participating subjects. This 
clinical investigation has been designed to involve as little pain, discomfort, fear and any other 
foreseeable risks as possible of the subjects. The risk threshold and degree of distress to subjects are 
defined in the risk analysis.  
 
 
 
8 Treated subjects include subjects that are actually implanted with the device, or had a treatment attempt with 
the device.  
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5. OBJECTIVES, HYPOTHESES AND ENDPOINTS 
5.1. 
Primary objective & hypothesis 
To primary objective is to evaluate the clinical safety and performance of GATT-Patch in open liver 
surgery. 
It is expected that GATT-Patch will achieve hemostasis within a specified time frame in the majority of 
patients and having a good safety profile. Statistical criteria for acceptation or rejection of the 
hypothesis are provided in Section 7.1.  
5.2. 
Primary endpoint  
The primary performance endpoint is defined as non-inferiority of GATT-Patch compared to the 
standard of care regarding the percentage of cases achieving hemostasis at 3 minutes (i.e., 
demonstrate GATT-Patch is significantly greater than literature-based performance goal of 65.4%). 
Hemostasis will be defined by a grade of 0 (None/Dry) on the Surface Bleeding Severity Score (SBSS). 
The SBSS provides a validated score for assessment of bleeding at the target site, and consists of 6 
subscales (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe; not immediately life-threatening, 
5=extreme; immediately life threatening) [1]. Investigators will be trained on the assessment scale 
prior to the investigation to have consistent assessment of bleeding at the target site (Section 2.7). 
Achievement of hemostasis will be verified every 30 seconds, starting from the time that GATT-Patch 
is positioned and pressure is initiated. If hemostasis has not been achieved  after 5 minutes of 
application (SBSS 1-5), then treatment is considered a failure and additional hemostatic agents or 
techniques may be used.  
5.3. 
Secondary objectives & hypotheses 
The following secondary endpoints are defined: 
• 
Mean time to hemostasis (seconds) 
• 
Percentage of hemostasis at 30, 60, 90, 120 and 150 seconds 
There will be no formal hypothesis testing on the secondary performance endpoints.  
5.4. 
Safety objective and safety endpoints  
The safety of GATT-Patch will be assessed by the nature, severity and incidence of device related 
adverse events. The adverse events found for GATT-Patch will be compared to the current knowledge 
and state of the art for hemostatic methods in open liver surgery to assess whether the device is 
associated with acceptable safety outcomes.   
Adverse events may include:   
• 
Toxic response  
• 
Thromboembolic event  
• 
(Re)Bleeding  
• 
Allergic reaction  
• 
Pain  
• 
New surgery  
• 
Infection  
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• 
Blockage of artery or vein / ischemia of organs  
• 
Damage of organs and vessels 
• 
Pulsatile hematoma  
• 
Closing of intestinal track  
• 
Biloma 
• 
Encapsulated or rolled-up device  
No formal hypothesis testing will be performed for the safety objective and endpoint of this clinical 
investigation.  
5.5. 
Exploratory endpoints 
In addition to the primary endpoint, the following exploratory endpoints will be recorded:  
• 
Surgery Time (minutes)  
• 
Blood loss (mL) during surgery 
• 
Blood Transfusion (mL) during hospitalization 
• 
SBSS (0-5) at the target bleeding site  
• 
Use of adjunct hemostatic agents/techniques (e.g. cautery, sutures or staples)  
• 
Amount of material needed versus bleeding surfaces  
• 
User satisfaction (questionnaire) 
5.6. 
Rationale for endpoint selection 
Endpoints were selected based on outcomes reported for other topical hemostatic agents in the 
scientific literature. The meta-analysis described in Section 3.2 identified 15 articles reporting on 
hemostatic techniques during open liver surgery, and this included 6 articles that specifically reported 
on the percentage of hemostasis at 3 minutes [4, 8-12]. Percentage of hemostasis at 3 minutes was 
found a clinically relevant performance outcome for success of various hemostatic techniques during 
open liver surgery. Data from different studies and techniques were pooled to define a performance 
goal for GATT-Patch to be used in the sample size calculation (Table 3). Detailed results per article are 
provided in a Literature Review Report (DHF-01-SFT-166, Version 01). The performance goal of GATT-
Patch is based on the lower bound of the pooled rate of hemostasis at 3 minutes. 
TABLE 3: SUMMARY OF PRIMARY ENDPOINT OUTCOME REPORTED IN SCIENTIFIC LITERATURE AND USED IN 
SAMPLE SIZE CALCULATION 
Reference 
Group 
N 
Time to 
hemostasis # 
Hemostasis at 
3 min 
6 RCTs 
TachoSil, ORC (Surgicel), 
Sangustop, Veriset, Grifols, 
Fibrocaps, Gelatin sponge 
(Gelfoam or Spongostan) 
799 patients 
 
Range: 1 min- 
5.5 min  
Weighted 
average: 
74.8%  
(95% CI: 65.4% 
to 83.1%) 
 
 
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6. DESIGN OF THE CLINICAL INVESTIGATION 
6.1. 
General 
This is a pre-market, prospective, single arm, multicenter first-in-human clinical investigation.  
The clinical investigation will be split into 2 stages:  
• 
Stage I of the clinical investigation will enroll a small cohort of subjects within which the initial 
safety of GATT-Patch will be evaluated. A maximum of 12 subjects (~25% of the overall 
population) will be treated9 at a maximum of 3 sites, after which the enrollment into the 
clinical investigation will be paused. At minimum, 2 subjects shall be treated per site. A DMC 
will review safety in this subset of subjects and decides whether the study may proceed 
(Section 13.8) 
• 
Stage II of the clinical investigation will enroll subjects until 39* Stage II subjects have been 
treated with the investigational device. (*Note: The number of Stage II subjects may increase 
to a maximum of 61 treated subjects [56 evaluable Stage II subjects, assuming 7.5% drop-out 
rate] if a sample size increase is deemed necessary based on the interim sample size re-
estimation).  Stage II will be used to evaluate safety and performance of GATT-Patch.  
In both Stage I and Stage II, subjects will follow the same clinical investigation pathway. Stage I subjects 
will be analyzed for safety only, whereas Stage II subjects will be analyzed for both safety and 
performance.  
6.2. 
Investigational device and comparators 
This is an uncontrolled clinical investigation. Subjects will be treated with GATT-Patch (5x10cm). 
6.3. 
Subjects 
The clinical investigation will enroll subjects that are candidate for elective open liver surgery. 
6.3.1. 
Inclusion criteria 
• 
Subject is scheduled to undergo an elective open surgery on the liver;  
• 
Subject is willing and able to give written informed consent for investigation participation;  
• 
Subject is 18 years of age or older at the time of enrollment;  
• 
Subject has been informed of the nature of the clinical investigation.  
A subject must meet all of the following intraoperative inclusion criteria to be treated with the 
investigational device:  
• 
Subject in whom the Investigator is able to identify a target bleeding site at the liver resection 
plane for which any applicable conventional means for hemostasis (e.g. suture, ligature or 
cautery) are ineffective or impractical and the choice is made to use a topical hemostat for 
control of hemostasis;  
• 
Subject has a target bleeding site with a SBSS of 1, 2, or 3. 
 
9 Treated subjects include subjects that are actually implanted with the device, or had a treatment attempt with 
the device.  
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6.3.2. 
Exclusion criteria 
A subject must not meet any of the following pre-operative exclusion criteria to be enrolled into the 
clinical investigation:  
• 
Subject is scheduled to undergo surgery on other organs besides the liver (e.g. pancreas, 
colon, lungs); 
• 
Subject is taking multiple antithrombotic therapies in therapeutic dosage up to the time of 
surgery, allowing exclusive use of acetylsalicylic acid; 
• 
Subject has platelet count <100 x 109/L, an activates partial thrombin time of >100s, or 
international normalized ratio >2.5; 
• 
Subject is pregnant, planning on becoming pregnant or actively breast-feeding during the 
follow-up period;  
• 
Subject has a known hypersensitivity to brilliant blue (FD&C Blue #1);  
• 
Subject has an active or suspected infection at the surgical site;  
• 
Subject has a total bilirubin level of ≥ 2.5 mg/dl;   
• 
Subject has had or has planned to receive any organ transplantation;  
• 
Subject has American Society of Anesthesiologists (ASA) classification of 4/5;  
• 
Subject has a life expectancy of less than 3 months;  
• 
Subject has a documented severe congenital or acquired immunodeficiency;  
• 
Subject in whom the investigational device will be used at the site of a synthetic graft or patch 
implant;  
• 
Subject is currently participating or has participated in another clinical investigation within the 
past 30 days that may affect the endpoints of the study, such as trials related to the surgical 
procedure, and on anti-coagulation;   
• 
Subject is not appropriate for inclusion in the clinical investigation, per the medical opinion of 
the Investigator;  
• 
Subject has any incidental (pre- and peri-operative) findings deemed by the Investigator to 
potentially jeopardize the safety or welfare of the patient.  
6.3.3. 
Representativeness of included population  
This clinical investigation will enroll subjects that are candidate for open liver surgery. Subjects with 
an appropriate bleeding site (SBSS of 1, 2, or 3) will be treated with GATT-Patch. Therefore, the 
included population is considered a representative sample for the intended use of GATT-Patch. 
6.3.4. 
Definition of enrollment 
A subject is considered enrolled in the clinical investigation after they have provided written informed 
consent, and if they meet the preoperative eligibility criteria (Section 6.3.1 and Section 6.3.2). The 
study will treat up to 73 subjects with the investigational device. Treated subjects include subjects 
that are actually implanted with the device, or had a treatment attempt with the device. 
6.3.5. 
Randomization 
N/A. This is a non-randomized clinical investigation. 
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6.3.6. 
Sample size 
The current plan is to treat a total of up to 51 subjects with GATT-Patch, with a maximum of 153 
replaceable subjects that may be enrolled (Section 6.3.9). However, the total sample size may increase 
to a maximum of 73 treated subjects based on the interim sample size re-estimation. The sample size 
calculation is provided in Section 7.2. It is expected that a comparable number of subjects is enrolled 
and treated at each investigational site.  
In Stage I, there is a minimum of 2 subjects to be treated by each site (maximum of 3 sites). In Stage 
II, there is no minimum or maximum number of subjects to be enrolled or treated by each site, 
however distribution between participating sites is monitored during the enrolment period.  
6.3.7. 
Study duration 
The enrollment period is expected to take approximately 6 months. The per subject duration of the 
clinical investigation from treatment to final follow-up will be approximately 6 weeks. With a 2-week 
temporary hold on enrollment for the safety evaluation, the total expected duration of the clinical 
investigation is, therefore, approximately 8 months. GATT-Patch is expected to resorb within 4-6 
weeks, and 6 weeks follow-up is therefore considered sufficient for the assessment of performance 
and safety of the device. 
6.3.8. 
Subject withdrawal, discontinuation and study end 
A subject may withdraw or discontinue participation at any time during the clinical investigation. There 
is no need to provide a reason for withdrawal or discontinuation. The investigator may also decide to 
stop a subject’s participation in the clinical investigation, for example due to non-compliance to the 
clinical investigation plan or if the investigator feels it is in the subject’s best interest to stop.   
The Sponsor or its representative will be notified immediately when a subject is withdrawn or 
discontinued for any reason. Premature clinical investigation end date and reason (if known) will be 
documented on the case report forms. If a subject fails to return for the follow-up visit, the investigator 
will attempt to contact the subject to determine and document the reason for the subject failed to 
return and to encourage compliance with the study visit schedule. The investigator will ask for the 
subject’s permission to follow his/her status/condition outside the study. 
The data collected up to the time point the subject has withdrawn or discontinued will be included as 
part of the clinical investigation results. Additional safety information may be requested from a 
withdrawn or discontinued subject if it is considered clinically relevant. Subjects who withdrawn from 
the study will receive standard of care defined by applicable treatment protocol(s) for the disease at 
the investigational site. If any additional care is necessary because of the subjects' participation in the 
clinical investigation, this will be provided to the subject by the investigational site. 
6.3.9. 
Subject replacement 
The current plan is to treat a total of 51 subjects with the investigational device. However, the total 
sample size may increase to a maximum of 73 treated subjects based on the interim sample size re-
estimation. There will be no replacement of subjects who have been treated with the investigational 
device. Intraoperative eligibility after informed consent is estimated at 50%, where the other 50% of 
patients will have no bleeding requiring device use. In case this 50% is an underestimate of 
intraoperative inclusion, there is a limitation of replacement that is set at 153 patients, representing 
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a rate of 25% of patients being able to be included intraoperatively. A re-evaluation of inclusion and 
exclusion criteria will be performed when a total of 51 treated subjects is not reached when the 
maximum of 153 subjects are replaced. 
6.3.10. Investigational sites 
This clinical investigation will be conducted in the Netherlands. Up to 7 sites will participate in this 
clinical investigation, with a maximum of 3 sites in Stage I. Any differences between site environment 
will be minimized through central training of the investigators and adherence to the same clinical 
investigation plan. Each site has a clinical environment that is representative of the normal conditions 
of use of the device in the target population.  
Contact and site details of each participating site are listed in a separate document. Emergency contact 
details are provided the contact information sheet on page 4. 
6.4. 
Procedures 
GATT-Patch will be used to control bleeding during open liver surgery. Each surgery will be performed 
according to the standard procedures of the hospital, with exception of the use of GATT-Patch. GATT-
Patch will be used if the subject has an appropriate bleeding site (SBSS 1, 2 or 3 and no 
contraindications).   
6.4.1. 
Schedule of assessments 
Table 4 provides a schedule of assessment for subjects screened and enrolled in the clinical 
investigation. All assessments are applicable for treated subjects, while only the assessments related 
to ‘screening’ and ‘admission’ are applicable for subjects that are enrolled but not treated.  
TABLE 4: SCHEDULE OF ASSESSMENTS 
Assessments 
Screening 
Admission 
before surgery 
Treatment 
with 
investigational 
device 
Hospitalization 
after surgery 
Week 6  
(±2 weeks) 
Post-
procedure* 
Informed consent  
X 
 
 
 
 
Inclusion 
and 
Exclusion Criteria 
X 
X 
X 
 
 
Baseline 
demographics 
X 
 
 
 
 
Physical examination 
X 
X 
 
 
 
Relevant 
concomitant 
medication** 
X 
X 
 
 
X 
Medical 
history/Allergy 
X 
 
 
 
 
Laboratory tests 
X 
X 
 
X 
 
Procedural data 
 
 
X 
 
 
Adverse events  
 
 
X 
X 
X 
User questionnaire  
 
 
X 
 
 
Ultrasound imaging 
 
 
 
 
X 
* Some subjects may have an additional phone consultation at 2-6 weeks post-procedure for the assessment of 
safety during Stage I of the clinical investigation. This visit will include assessment of adverse events, and will 
only take place for subjects in stage I of the clinical investigation who did not complete the 6 weeks follow-up 
visit. 
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** Relevant concomitant medication will be captured from screening to study completion. Medication is 
considered relevant when related to any of the study eligibility criteria, or when it may affect any of the 
endpoints, at the discretion of the investigator. Relevant medication covers at a minimum the medication for 
the underlying medical condition for the surgical procedure, and medication for concomitant chronic 
pathologies. 
6.4.1.1. 
Laboratory Tests 
Laboratory tests will be collected prior to surgery, and through the postsurgical admission. The 
collection of laboratory tests is specified in Table 5. Tests that are indicated with an ‘X’ are required 
per this clinical investigation plan. Tests that are indicated with an ‘*’ are not dictated by this clinical 
investigation plan: results will only be captured if these test data is collected per standard of care.  
TABLE 5: LABORATORY TESTING SCHEDULE 
Laboratory Tests 
Screening 
Admission before 
surgery 
Through 
admission* 
Hematology 
 
 
 
Hemoglobin (Hb) 
X 
* 
X 
Thrombocytes 
X 
* 
* 
Coagulation 
 
 
 
Prothrombin time (PT) 
X 
* 
* 
Activated partial thromboplastin time (aPTT) 
X 
* 
* 
International Normalized Ratio (INR) 
X 
* 
* 
Chemistry 
 
 
 
Bilirubin 
X 
* 
* 
Calcium 
* 
* 
* 
Potassium 
* 
* 
* 
Sodium 
* 
* 
* 
Chloride 
* 
* 
* 
Albumin 
* 
* 
* 
AST 
* 
* 
* 
ALT 
* 
* 
* 
* Timing of collection if this data will be according to standard of care hospital procedures.  
6.4.2. 
Equipment for assessment 
The following equipment will be required for assessment of endpoints: 
• 
Ultrasound imaging system 
• 
Stopwatch 
6.4.3. 
Screening 
During the Screening phase, the following assessments will be performed: 
Informed consent 
If the patient meets the criteria of the initial screening, informed consent will be obtained. Before 
performing any study-specific procedures, the potential subject must be thoroughly informed about 
all aspects of the clinical investigation, including scheduled study visits and activities, and must have 
signed the Ethics Committee-approved informed consent form. See also Section 12 for more details.  
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Baseline data 
The following baseline demographics will be captured, if available:  
• 
Demographics: Subject demographics (age, gender, race) will be recorded.  
• 
Physical examination 
• 
Relevant concomitant medication 
• 
Medical history: The subject’s relevant medical history will be recorded. Medical history is 
considered relevant when it is currently ongoing, when it is related to any of the study 
eligibility criteria, or when it may affect any of the endpoints. Relevant medical history covers 
at a minimum the underlying medical condition for the surgical procedure.  
• 
Laboratory test data 
6.4.4. 
Admission before surgery 
The following baseline data will be captured during admission before surgery:  
• 
Confirmation of inclusion/exclusion criteria 
• 
Physical examination 
• 
Relevant concomitant medication 
• 
Laboratory test data  
6.4.5. 
Treatment  
GATT-Patch will be used to control bleeding during open liver surgery. Each surgery will be performed 
according to the standard procedures at the hospital, with exception of the use of GATT-Patch. GATT-
Patch will be used if the subject has an appropriate bleeding site (SBSS 1, 2 or 3 and no 
contraindications). Use of GATT-Patch will only be considered during and/or after resection when 
control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective 
or impractical, and the surgeon has made the decision to apply a topical hemostatic product. If there 
are multiple appropriate bleeding sites, the first encountered bleeding site that requires topical 
hemostat application will be considered for the primary endpoint. 
The handling instructions for GATT-Patch are provided in the Instructions for Use of the device (DHF-
01-QR-008). Select the appropriate size of the patch so that it overlaps the margins of the bleeding 
surface by at least 1 cm. The patch may be cut to the desired size and shape. Dry gloves and surgical 
instruments (forceps, scissors) should be used to handle, cut and apply GATT-Patch. GATT-Patch can 
be placed on a wet gauze prior to placement, and after excess blood is removed from the bleeding 
site, directly applied on the bleeding site with continuous pressure. Failure is considered if after 5 
minutes no hemostasis was obtained. Up to 3 full patches may be used. The patch may be applied to 
or overlap a previously applied patch (“patch on patch”). 
Achievement of hemostasis will be verified every 30 seconds. The primary performance endpoint is 
defined by the percentage of cases achieving hemostasis at 3 minutes. Hemostasis will be defined by 
a grade of 0 (None/Dry) on the SBSS10. If hemostasis has not been achieved after 5 minutes of 
 
10 The Surface Bleeding Severity Score (SBSS) provides a validated score for assessment of bleeding at the target 
site, and consists of 6 subscales (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe; not immediately life-
 
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application (SBSS 1-5), then treatment is considered a failure and other additional hemostatic 
agents/techniques may be used. This should not be GATT-Patch. In the case 3 full GATT-Patches have 
been applied and a bleeding site other than a previously treated target bleeding site is identified, other 
additional hemostatic agents/techniques may be used.  
The investigators will complete a user questionnaire at the end of each procedure. During surgery, 
photos and videos may be taken for documentation and/or training purposes. Patients will not be 
recognizable in these photos and videos. 
The following procedural data will be collected:  
• 
Surgical procedure data:  
o Date of surgery (month/year) 
o Procedure length (from start incision to surgical site closure)  
o Number of devices used  
o Blood loss (mL)  
o SBSS (0-5) of target bleeding site 
o Use of adjunct hemostatic agents/techniques (e.g., cautery, sutures or staples)  
o Amount of material needed versus bleeding surfaces  
o User satisfaction per investigator per procedure (questionnaire)   
• 
Hospitalization:  
o Duration of patient’s time spent in the intensive care unit 
o Total hospitalization period 
o Blood transfusion (mL)  
• 
Intraoperative device and/or procedure related adverse events 
• 
Intraoperative device deficiencies  
6.4.6. 
Hospitalization after surgery 
The following data will be captured the during hospitalization after surgery:  
• 
Laboratory test data  
• 
Intraoperative device and/or procedure related adverse events 
6.4.7. 
Visit 1 (Week 6) 
At follow-up Week 6 (±2 weeks), subjects will undergo ultrasound examination of the resection area 
to identify any encapsulation or rolled-up device, or evidence of a biloma or pseudo-aneurysm. In 
addition, relevant concomitant medications and adverse events will be assessed.  
Optional: Some subjects may have an additional phone consultation at 2-6 weeks post-procedure for 
the assessment of safety during Stage I of the clinical investigation. This visit will include assessment 
of adverse events, and will only take place for subjects in stage I of the clinical investigation who did 
not yet complete the 6 weeks follow-up visit. 
 
threatening, 5=extreme; immediately life threatening) (Spotniz, 2017). Investigators will be trained on the 
assessment scale prior to the investigation to have consistent assessment of bleeding at the target site. 
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6.4.8. 
Study completion 
The study is completed when the 51 subjects were treated with the investigational device or when 
the number of subjects needed based on the planned interim analysis of the primary performance 
endpoint is treated with the investigational device, and the last treated subject completed the follow-
up Visit 1, is lost to follow-up or pre-maturely ended the study for some other reason. Subjects are 
lost to follow-up when the following steps have been taken: 
• 
Two phone calls should be made to the subject. Each attempt should be clearly documented 
in the source documents and the response or lack thereof should be captured.   
• 
If there is no response to the phone calls, then certified letter should be written to the subject. 
A copy of the letter should be retained in the subject’s source document. 
• 
After a period of two (2) weeks following completion of the above actions, the subject will be 
considered Lost to Follow-up. The sponsor should be notified and appropriate eCRF should be 
completed.   
6.4.9. 
Activities by Sponsor representatives 
Procedures related to the clinical investigation will be performed by the principal investigator, study 
coordinators, and/or other authorized study staff, as applicable. A Sponsor representative may be 
present during investigational procedures for technical support. Photos and videos may be taken by 
the Sponsor representative for documentation and/or training purposes. Patients will not be 
recognizable in these photos and videos. 
6.5. 
Minimization of bias 
Potential for bias during this clinical investigation has been minimized by conduct under the terms of 
an approved clinical investigation plan, use of specific inclusion and exclusion criteria, careful 
definitions for clinical investigation procedures and outcomes and prospectively defined methods of 
data analysis (see also Section 7.8).  
6.6. 
Potential confounding factors 
Investigators will be trained on the use of the device, and SBSS prior to initiation of the clinical 
investigation. 
6.7. 
Scientific robustness 
The clinical investigation design was based on the current knowledge/state of the art. Scientific 
robustness and validity is demonstrated by adequate sample size calculation prior to the study 
(Section 7.2). The data that is generated through this clinical investigation is therefore considered to 
reflect clinical safety and performance outcomes relevant for the intended use of GATT-Patch. 
6.8. 
Monitoring plan 
Monitoring will be conducted by Avania BV. Details of the monitoring activities are outlined in the 
Monitoring Plan.  
 
 
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7. STATISTICAL CONSIDERATIONS 
7.1. 
Statistical design & methods 
This study utilizes an adaptive design with an interim analysis planned when 69% (n≈25) of the planned 
evaluable Stage II subjects are treated. The interim analysis will be conducted for the purposes of 1) 
stopping the trial early for overwhelming performance success based on a group sequential design 
using the Lan-DeMets approach11 with an O'Brien-Fleming alpha-spending function or 2) for increasing 
the sample size based on the Mehta-Pocock Promising Zone approach12. 
Descriptive statistics will be presented for each variable. Continuous variables will be summarized 
using descriptive statistics (number of subjects, mean, median, quartiles, standard deviation, 
minimum, and maximum). Categorical variables will be summarized using frequencies and 
percentages of subjects in each category.  
7.1.1. 
Primary endpoint analysis 
The primary performance endpoint is the percentage of patients achieving hemostasis at 3 minutes 
using GATT-Patch. 
The statistical null (H0) and alternative (H1) hypotheses are the following: 
H0: pGATT ≤ 65.4% 
H1: pGATT > 65.4% 
where pGATT is the percentage of patients achieving hemostasis at 3 minutes using GATT-Patch and 
65.4% is the performance goal (PG) to demonstrate non-inferiority of GATT-Patch compared to 
current knowledge (literature-based) of standard of care.  
The interim analysis of the primary performance endpoint will be performed once approximately 69% 
(n≈25) of the planned evaluable Stage II subjects are treated. To account for multiple testing and 
control the overall Type I error rate of the study at one-sided 0.025 level, a group-sequential design 
will be used based on the Lan-DeMets approach with an O'Brien-Fleming alpha-spending function. 
Based on this method, a test to demonstrate that the percentage of patients achieving hemostasis at 
3 minutes using GATT-Patch is significantly greater than 65.4% will be performed at the interim review 
using the continuity corrected Z-test of proportion at a one-sided 0.0070 significance level. If the 
statistical analysis of the primary endpoint at the interim review yields a one-sided p-value less than 
0.0070, then the DMC may recommend stopping the trial for overwhelming successful performance. 
If the one-sided p-value is not less than 0.0070, then the study will continue and a final analysis to 
demonstrate that the percentage of patients achieving hemostasis at 3 minutes using GATT-Patch is 
significantly greater than 65.4% will be performed using the continuity corrected Z-test of proportion 
at the one-sided 0.0229 significance level. A sample size increase based on the Mehta-Pocock 
Promising Zone approach will not require an additional penalty to the final significance (alpha) level. 
The primary analysis of the primary performance endpoint will be on the FAS with available data. The 
 
11 Lan KKG, DeMets DL. Discrete Sequential Boundaries for Clinical Trials. Biometrika. 1983; 70, 659–663. 
12 Mehta C, Pocock S. Adaptive increase in sample size when interim results are promising: a practical guide with 
examples. Stat Med. 2011;30:3267–84. 
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primary performance endpoint will also be analyzed on the PP population as a secondary analysis. The 
number and percentage of patients achieving hemostasis at 3 minutes using GATT-Patch will be 
reported, including the confidence interval (CI) of the percentage based on Wilson’s method with 
continuity correction and the one-sided p-value from the continuity corrected Z-test of proportion. In 
order to correspond with the significance levels that will be used at the interim and final analyses, a 
two-sided 98.6% CI will be calculated for the interim analysis and 95.42% CI will be calculated for the 
final analysis.          
7.1.2. 
Secondary endpoint analysis  
The mean, standard deviation, median, quartiles, minimum, and maximum time to hemostasis 
(seconds) will be presented. The number and percentage of subjects achieving hemostasis at 30, 60, 
90, 120, and 150 second will be presented.  
There will be no formal hypothesis testing of these secondary endpoints. 
7.1.3. 
Safety endpoints 
Safety analyses will be performed for the Safety population and will be descriptive and narrative in 
nature, including definitions of severity and relation for all adverse events, and focusing on serious 
adverse events.   
Adverse events may include:   
• 
Toxic response  
• 
Thromboembolic event  
• 
(Re)Bleeding  
• 
Allergic reaction  
• 
Pain  
• 
New surgery  
• 
Infection  
• 
Blockage of artery or vein / ischemia of organs  
• 
Damage of organs and vessels 
• 
Pulsatile hematoma  
• 
Closing of intestinal track  
• 
Biloma 
• 
Encapsulated or rolled-up device  
The number and percent of patients with any adverse event, any serious adverse event, any adverse 
event related to the study device, and any adverse event related to study procedure will be presented. 
No formal hypothesis testing will be performed.  
7.1.4. 
Exploratory Endpoints 
The following exploratory endpoints will be analyzed on the FAS and PP populations:  
• 
Surgery time (minutes)  
• 
Blood loss during surgery (mL)  
• 
Blood transfusion during hospitalization (mL)  
• 
SBSS (0-5)  
• 
Use of adjunct hemostatic agents/techniques (e.g. cautery, sutures or staples)  
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• 
Amount of material needed versus bleeding surfaces  
• 
User satisfaction (questionnaire) per investigator per procedure  
Descriptive statistics will be presented for each endpoint. Continuous variables will be summarized 
using descriptive statistics (number of subjects, mean, median, quartiles, standard deviation, 
minimum, and maximum). Categorical variables will be summarized using frequencies and 
percentages of subjects in each category. No formal hypothesis testing will be performed for these 
exploratory endpoints. Exploratory endpoints will be analyzed on the FAS and PP populations.  
7.2. 
Sample size 
The plan is to enroll and treat the following number of subjects across two stages:   
• 
Stage I: maximum of 12 subjects  
• 
Stage II: 39 subjects (36 evaluable subjects, assuming 7.5% drop-out rate)* 
*Note: The number of Stage II subjects may increase to a maximum of 61 treated subjects (56 
evaluable subjects, assuming 7.5% drop-out rate) if a sample size increase is deemed necessary based 
on the interim sample size re-estimation 
The sample size of Stage II is powered on the primary endpoint to allow for assessment of non-
inferiority of GATT-Patch compared to the current knowledge (literature-based) of standard of care 
regarding the percentage of subjects achieving hemostasis at 3 minutes.  
Assuming the true percentage of subjects achieving hemostasis at 3 minutes using GATT-Patch is 89%, 
then an evaluable sample size of 36 evaluable subjects from Stage II achieves over 90% power to 
demonstrate non-inferiority of GATT-Patch compared to current (literature-based) knowledge of 
standard care (i.e., demonstrate that the percentage achieving hemostasis at 3 minutes for the 
population treated with GATT-Patch is significantly greater than the performance goal of 65.4%) using 
a one-sided continuity corrected Z-test of proportion. The sample size takes into account the interim 
analysis of the primary performance endpoint (performed when approximately 69% of the planned 
evaluable Stage II subjects are treated, i.e., n≈25 evaluable Stage II subjects) based on a group 
sequential design to allow for possible early stopping for overwhelming performance success. The Lan-
DeMets approach with an O'Brien-Fleming alpha-spending function is used to control the overall Type 
I error rate of the study at a one-sided 0.025 level. 
If the study does not stop for overwhelming performance success at the interim review, then an 
unblinded conditional power calculation and sample size re-estimation will also be conducted at the 
interim review. The sample size re-estimation analysis will be performed by an independent 
statistician according to the Mehta-Pocock Promising Zone approach. The conditional power for 
demonstrating that the primary performance endpoint is significantly greater than performance goal 
of 65.4% will be calculated under the current protocol-specified evaluable sample size (n=36), under 
the assumption that the observed interim treatment effect (i.e., percentage achieving hemostasis at 
3 minutes) is the true treatment effect size.  If the conditional power under the protocol-specified 
evaluable sample size is between 39% to <90% (the promising zone), the evaluable sample size may 
increase to maintain conditional power of 90%. The sample size may increase to a maximum of 56 
(i.e., 20 additional) evaluable subjects for Stage II. Such a sample size increase based on the Mehta-
Pocock Promising Zone approach will not require an additional penalty to the final significance (alpha) 
level. 
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The performance goal was established on a systematic literature review and meta-analysis (see 
Section 5.6), that found the lower 95% confidence interval of the random-effects meta-analytical 
estimate of the percentage achieving hemostasis at 3 min to be 65.4%, based on previous studies for 
hemostatic techniques used in open liver surgery.  The assumption of the true rate of hemostasis at 3 
minutes being 89% for GATT-Patch is based on the pre-clinical evidence and clinical judgement.  
7.3. 
Analysis populations 
The following populations are defined for the analysis of the data: 
• 
Full Analysis Set (FAS): The FAS population will consist of all Stage II treated subjects. This 
population will be utilized as a primary analysis population for the primary and secondary 
performance endpoints and exploratory endpoints.  
• 
Per Protocol (PP): The PP population will consist of FAS subjects who do not have major 
protocol deviations with data analyzed according to treatment received. This population will 
be utilized as a secondary analysis population for the primary and secondary performance 
endpoints and exploratory endpoints. Major protocol deviations are defined in Section 9 of 
the protocol.   
• 
Safety Population: The Safety analysis population will consist of Stage I and Stage II treated 
subjects. This population will be utilized as the primary analysis population for the safety 
analyses. Summaries will be presented by study stage and overall.   
7.4. 
Missing data 
The primary analysis of the primary performance endpoint will be on the FAS population with available 
data. Reasonable efforts will be made to obtain complete data for all subjects; however, missing 
observations may occur due to subjects lost to follow-up or noncompliance with required 
assessments. Any missing data on study endpoints will be described. For the primary performance 
endpoint regarding achieving hemostasis at 3 minutes, a “tipping point” sensitivity analysis will be 
used to assess the effect of missing data on the results of the hypothesis testing of the primary 
endpoint. I.e., for the primary endpoint, if the null hypothesis is rejected on the FAS population with 
available data, then FAS patients who are missing will be imputed as a failure (i.e., not achieving 
hemostasis at 3 min), one at a time cumulatively, and the null hypothesis will be tested after each 
cumulative imputation until the “tipping point” is reached (i.e., until the null hypothesis is no longer 
rejected). There will be no imputation of missing data for other endpoints.  
7.5. 
Learning curve 
The influence of learning curve on results is considered negligible. Investigators will have extensive 
training on the investigational device prior to the start.  
7.6. 
Interim analysis 
A data monitoring committee (DMC) will monitor all emerging safety issues against pre-defined 
stopping rules of the clinical investigation (Section 13.8). Any Serious Adverse Events or other safety 
concerns during Stage I of the clinical investigation will be immediately referred, on a case-by-case 
basis, to the DMC for review against the stopping rules. A formal review of safety against the stopping 
rules will be conducted by the DMC when all subjects of the initial cohort (Stage I) are treated and 
have at least 2 week FU data available. The re-opening of recruitment will only be triggered by 
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authorization from the DMC to proceed. The DMC may decide to temporarily halt the clinical 
investigation in case of safety concerns. The stopping rules are defined in the DMC Charter. 
This study utilizes an adaptive design with an interim analysis of the primary performance endpoint 
planned for the purposes of 1) stopping the trial early for overwhelming performance success or 2) 
increasing the sample size if deemed necessary based on the interim sample size re-estimation. The 
interim analysis of the primary performance endpoint will be performed once approximately 69% 
(n=25) of the planned evaluable Stage II subjects are treated. To account for multiple testing and 
control the overall Type I error rate of the study at one-sided 0.025 level, a group-sequential design 
will be used based on the Lan-DeMets approach with an O'Brien-Fleming alpha-spending function. 
Based on this method, if the statistical analysis of the primary endpoint at the interim review yields a 
one-sided p-value less than 0.0070, then the DMC may recommend stopping the trial for 
overwhelming performance success. If the one-sided p-value is not less than 0.0070, then the study 
will continue. If the study does not stop for overwhelming performance success at the interim review, 
then an unblinded conditional power calculation and sample size re-estimation will also be conducted 
during the interim review. The sample size re-estimation analysis will be performed by independent 
statistician according to the Mehta-Pocock Promising Zone approach. The conditional power for 
demonstrating that the primary performance endpoint is significantly greater than performance goal 
of 65.4% will be calculated under the current protocol-specified evaluable sample size for the final 
analysis (n=36), under the assumption that the observed percentage achieving hemostasis at 3 
minutes at the interim analysis is the true rate of hemostasis at 3 minutes for the population. If the 
conditional power under the protocol-specified evaluable sample size is between 39% to <90% (the 
promising zone), then the evaluable sample size may increase to maintain conditional power of 90%; 
otherwise, the study will continue as is without a sample size increase. The sample size may increase 
to a maximum of 56 (i.e., up to 20 additional) evaluable subjects for Stage II. The DMC will review the 
results of the interim analysis of the primary performance endpoint and provide the recommendation 
to the sponsor (e.g., “continue study as is”, “increase sample size to xx”, “stop study for overwhelming 
performance success”).  
7.7. 
Statistical deviations 
The statistical deviations and assessment will be defined in the statistical analysis plan (SAP). Statistical 
deviations from the study protocol and/or from the final SAP will be described in the clinical 
investigation report. 
7.8. 
Management of bias 
The following activities are intended to reduce the risk of bias:   
• 
Prospective inclusion of study subjects from a consecutive cohort.  
• 
Adhere to procedures that take into account all the data. 
• 
Extensive training of investigators prior to the start of the clinical investigation to reduce the 
influence of a learning curve (Section 2.7).  
• 
Centralized assessment of (serious) adverse events by a data monitoring committee (DMC) 
(Section 13.8). 
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7.9. 
Pooled data 
In both Stage I and Stage II, subjects will follow the same clinical investigation pathway. The primary 
analysis of the performance and exploratory endpoints will only include Stage II subjects. However, a 
sensitivity analysis of the performance and exploratory endpoints may be conducted that includes 
both Stage I and Stage II subjects.  
For the primary endpoint, descriptive statistics (i.e., number and percent of patients achieving 
hemostasis at 3 minutes) will be presented separately for each investigational site. Logistic regression, 
with achieving hemostasis at 3 min (yes/no) as the dependent variable and investigational site as the 
independent variable, will be used to assess homogeneity across sites in the primary endpoint. The 
association between “investigational site” and the primary performance outcome will be assessed at 
the 0.1 significance level.  
 
 
 
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8. DATA MANAGEMENT 
8.1. Data entry and collection 
An electronic data capture (EDC) system with electronic Case Report Forms (eCRFs) will be used for 
the purposes of this clinical investigation. Subjects are uniquely identified by a clinical investigation 
subject number, consisting of a site identifier (two digits) and unique subject identifier (three digits) 
in the following format: xx-xxx. All eCRFs will be completed in English and the investigator, or 
investigator’s qualified designee, must review, electronically sign and date each completed eCRF 
where requested. The eCRFs will be completed in a timely manner after completion of the patient’s 
visit.   
The data reported on the eCRFs will be derived from source documents and be consistent with these 
source documents, and any discrepancies will be explained in writing.  Any change or correction to 
data reported on an eCRF will be dated, initialed, and explained if necessary, and will not obscure the 
original entry (i.e., an audit trail will be maintained). This applies to both written and electronic 
changes or corrections. 
8.2. Data review, database cleaning, and issuing and resolving data queries 
The data entered into the EDC will be fully validated, using clinical investigation-specific range and 
consistency checks and database listings. Queries will be issued to the site via the EDC system, and are 
to be resolved by the investigator or his designee using the EDC system. Data validation will be 
completed on a regular basis. The entire database will be re-validated to ensure that there are no 
outstanding data discrepancies prior to database lock. Any changes to the database after that time 
will require written agreement by the Sponsor.   
8.3. 
Procedures for verification, validation and securing of electronic clinical data 
systems  
Data will be collected and recorded using a validated EDC system that meets all requirements as set 
forth in the FDA and ISO standards. An audit trail is available for tracking all information that the EDC 
user enters, modifies or deletes. One electronic copy of the final database will be archived in the 
electronic database of Avania BV and another copy will be stored at GATT Technologies BV.  
The investigator or its designee will perform primary data collection drawn from original documents 
(printed, optical or electronic document containing source data), also referred to as source 
documents. Source documents will include, but are not limited to, progress notes, electronic data, 
screening logs, and recorded data from automated instruments. Data to be collected for purposes of 
the clinical investigation must not be entered directly into the eCRF before being recorded first in the 
source documents. All source documentation must be available for review by the study monitor during 
monitor visits. Source data is defined as all information in original records, certified copies of original 
records of clinical findings, observations, or other activities in a clinical investigation, necessary for the 
reconstruction and evaluation of the clinical investigation. 
It is the responsibility of the investigator to ensure that the site files are maintained in accordance with 
ISO14155 - Good Clinical Practice for Medical Devices and applicable regulations. 
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8.4. 
Case report forms 
The investigators will ensure the accuracy, completeness, legibility and timelines of the data reported 
in eCRF and in all required documentation. Data reported on the eCRF will be supported by the source 
documents with any discrepancies being explained. Any corrections made to documents will be done 
according to ISO 14155 guidelines. If an item is not available or is not applicable, this fact should be 
indicated. The investigator who has signed the clinical investigation plan signature page or his/her 
authorized designee is to personally sign the eCRFs to validate that the observations and findings are 
recorded on the eCRFs correctly and completely. The eCRFs are to be completed in a timely manner 
after the subject’s visit. Failure to meet the documentation requirements may lead to the 
disqualification of an investigator.  
8.5. 
Data retention 
The investigator maintains all clinical investigation records for the minimum time required in the 
country in which the clinical investigation is conducted, which will be at least 15 years. Records to be 
retained may include: all correspondence, documentation of device receipt and disposition, each 
subject’s case history and record of exposure to the device, the clinical investigation plan and 
amendments, Investigator Brochure, and dates and reasons for any deviations to the clinical 
investigation plan or as otherwise specified by the applicable laws and regulations.  
Furthermore, the documentation will be kept by GATT Technologies BV for a period of at least 15 years 
after the clinical investigation with the device in question has ended, or, in the event that the device 
is subsequently placed on the market, at least 10 years after the last device has been placed on the 
market.  
8.6. 
Subject confidentiality 
Participant confidentiality will be maintained throughout the clinical investigation in a way that 
ensures the information can always be tracked back to the source data. For this purpose, a unique 
subject identification code will be used that allows identification of all data reported for each subject. 
Data relating to the clinical investigation might be made available to third parties (for example in case 
of an audit performed by regulatory authorities) provided the data are treated confidentially and that 
the subject’s privacy is guaranteed. 
8.7. 
Data protection 
Data protection will be ensured in accordance with Regulation (EU) 2016/679 (General Data 
Protection Regulation, GDPR). This includes the following:  
Personal data will be: 
• 
processed lawfully, fairly and in a transparent manner in relation to the data subject 
(‘lawfulness, fairness and transparency’); 
• 
collected for specified, explicit and legitimate purposes and not further processed in a manner 
that is incompatible with those purposes; further processing for archiving purposes in the 
public interest, scientific or historical research purposes or statistical purposes will, in 
accordance with Article 89(1), not be considered to be incompatible with the initial purposes 
(‘purpose limitation’); 
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• 
adequate, relevant and limited to what is necessary in relation to the purposes for which they 
are processed (‘data minimization’); 
• 
accurate and, where necessary, kept up to date; every reasonable step must be taken to 
ensure that personal data that are inaccurate, having regard to the purposes for which they 
are processed, are erased or rectified without delay (‘accuracy’); 
• 
kept in a form which permits identification of data subjects for no longer than is necessary for 
the purposes for which the personal data are processed; personal data may be stored for 
longer periods insofar as the personal data will be processed solely for archiving purposes in 
the public interest, scientific or historical research purposes or statistical purposes in 
accordance with Article 89(1) subject to implementation of the appropriate technical and 
organizational measures required by this Regulation in order to safeguard the rights and 
freedoms of the data subject (‘storage limitation’); 
• 
processed in a manner that ensures appropriate security of the personal data, including 
protection against unauthorized or unlawful processing and against accidental loss, 
destruction or damage, using appropriate technical or organizational measures (‘integrity and 
confidentiality’). 
8.8. 
Other aspects of clinical quality assurance 
The clinical investigation will be conducted and monitored by Avania BV under the sponsorship of 
GATT Technologies BV. The Sponsor, or the Sponsor’s representative, may conduct audits at the 
investigational sites. Audits may include, but are not limited to, device supply, presence of required 
documents, the informed consent process, and comparison of CRFs with source documents. The 
investigator agrees to participate with audits conducted at a reasonable time, in a reasonable manner. 
8.8.1. 
Monitoring 
A qualified monitor from Avania BV or a sponsor designee, will visit the site prior to the start of the 
clinical investigation and during the course of the clinical investigation, in accordance with the 
monitoring plan. Monitoring will be performed according to ISO14155. Data will be evaluated for 
compliance with the clinical investigation plan and accuracy in relation to source documents. 
Following written standard operating procedures, the monitors will verify that the clinical 
investigation is conducted and data are generated, documented and reported in compliance with the 
clinical investigation plan, ISO14155 and the applicable (national) regulatory requirements. Details of 
the monitoring requirements are provided in the Monitoring Plan. 
8.9. 
Sample retention 
All laboratory test samples collected at sites will be retained and/or destroyed per standard procedure 
at site. 
 
 
 
 
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9. AMENDMENTS, DEVIATIONS & WAIVERS 
9.1. 
Amendments  
Investigators may not modify (amend) this clinical investigation plan without obtaining written 
concurrence of the Sponsor, involved Ethics Committee(s), and applicable regulatory authorities.  
9.2. 
Deviations and Waivers 
Investigators may not deviate from this clinical investigation plan without first receiving approval in 
writing from the Sponsor, involved Ethics Committee(s), and applicable regulatory authorities, except 
to protect the rights, safety and well-being of human subjects under emergency circumstances. All 
deviations will be documented on eCRFs. The use of waivers from the Clinical Investigation Plan is 
prohibited.  
9.2.1. 
Reporting  
Investigators will also adhere to procedures for reporting deviations to the involved Ethics 
Committee(s) in accordance with their specific reporting policies and procedures.  
Under emergency circumstances, deviations from the clinical investigation plan to protect the rights, 
safety and wellbeing of human subjects may proceed without prior approval of the Sponsor and the 
EC. Such deviations will be documented and reported to the Sponsor and the EC as soon as possible, 
and will be in accordance with the national and local legislations.  
Deviations from the clinical investigation plan to the in/exclusion criteria and deviations that affect 
the primary endpoints are considered major deviations. Deviations that may affect the secondary 
endpoints are considered minor deviations. All deviations will be reviewed by the medical monitor. 
The medical monitor is responsible for major/minor classification of the deviations.   
9.2.2. 
Corrective and preventive actions 
GATT Technologies BV or its representatives will evaluate deviations to the clinical investigation plan 
during monitoring visits. Individual event corrective and preventive actions may be recommended at 
that time. In addition, deviations occurring across investigational sites will be reviewed by GATT 
Technologies BV on a periodic basis to determine if more global preventive actions may be required.    
9.2.3. 
Investigator disqualification criteria 
GATT Technologies BV reserves the right to terminate an investigator/investigational site for any of 
the following reasons: 
• 
Failure to secure subject informed consent including protection of personal data prior to 
enrollment. 
• 
Failure to report safety events within 24 hours of discovery after learning of the event. 
• 
Failure to report serious adverse device effects within 24 hours of discovery. 
• 
Repeated investigational plan deviations. 
• 
Repeated failure to appropriately complete case report forms. 
• 
Failure to enroll an adequate number of subjects. 
• 
Loss of or unaccounted for investigational product inventory. 
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9.2.4. 
Follow-up management 
Protocol deviations will be reported in the EDC. Subjects will receive standard of care in case a protocol 
deviation leads to the end, temporary halt or early termination of the investigation. The standard of 
care is defined by the applicable treatment protocol(s) for the disease at the investigational site. Each 
patient will receive a patient card describing the device and manufacturer, study investigator and site, 
and includes any important information on the device itself. The patient card further ensures the 
identification of the device and continued traceability after study termination (Section 2.8). 
 
 
 
 
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10. DEVICE ACCOUNTABILITY 
Access to investigational devices will be controlled and the investigational devices will be used only in 
the clinical investigation and according to the clinical investigation plan. The Sponsor will keep records 
to document the location of all investigational devices from shipment of investigational devices to the 
investigational sites until return or disposal. Investigational devices can be traced by a unique LOT 
number (Section 2.8). The Sponsor will have instructions in place and make packaging materials 
available, if applicable, for the safe return or disposal of investigational devices, including potentially 
hazardous devices.  
The principal investigator or an authorized designee will keep records documenting the receipt, use, 
return and disposal of the investigational devices, which will include:  
a) name(s) of person(s) who received, used, returned or disposed the device, 
b) the date of the receipt,  
c) identification of each investigational device (batch number/serial number or unique code),  
d) quantity of investigational devices, 
e) the expiry date, if applicable,  
f) the date or dates of use,  
g) subject identification,  
h) the date of return of unused, expired or malfunctioning investigational devices, if applicable.  
i) 
the date and documentation of disposal of the investigational devices as per instructions of 
the Sponsor, if applicable.  
Written procedures will be established for the entire process of device accountability.  
 
 
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11. STATEMENTS OF COMPLIANCE 
This clinical investigation will be conducted in compliance with the principles that have their origin in 
the latest version of the Declaration of Helsinki, this clinical investigation plan, requirements of the 
approving Ethics Committee(s) and Regulating Authorities, ISO 14155:2020, and other applicable 
national and regional regulatory requirements whichever provides the greater protection of the 
individual.  
This clinical investigation will not be initiated until approval has been obtained from the Ethics 
Committee(s) and the Regulating Authorities. Any additional requirements imposed by the Ethics 
Committee(s) or Regulating Authorities will be followed, as appropriate. No deviation from the clinical 
investigation plan will be implemented without the prior review and approval of the Ethics 
Committee(s) except where it may be necessary to eliminate an immediate hazard to a subject. In 
such case, the deviation will be reported to the Ethics Committee and applicable regulatory authorities 
as soon as possible.  
Clinical trial insurance will be secured prior to investigation initiation.  
The Clinical Trial Agreement will outline the agreements made between the Sponsor and 
investigational sites.  
 
 
 
 
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12. INFORMED CONSENT PROCESS 
The investigator is responsible for assuring that written informed consent is obtained from each 
patient prior to participation in the clinical investigation. Should the investigator delegate the 
responsibility of conducting the informed consent process to a designee, the investigator must ensure 
and document appropriate training of the authorized designee.  
The investigator will use an approved informed consent form that was prepared in accordance with 
this clinical investigation plan, ISO 14155 and Regulatory Authority’s requirements. 
Subjects must be fully counselled and informed of their options, risks and benefits, and should have 
every opportunity to ask questions about participation in the clinical investigation. This process 
includes a thorough explanation of the patient information letter and informed consent form that the 
subject will be asked to sign, acknowledging that they understand and consent to participate in the 
clinical investigation. 
While an investigator may discuss availability of the investigation with a prospective patient without 
first obtaining consent, informed consent must always be obtained from a patient prior to initiation 
of any clinical procedures dictated by the clinical investigation plan that are performed solely for the 
purpose of determining eligibility to participate in the clinical investigation. A copy of the signed 
statement of informed consent will be provided to the patient.   
If new information regarding the investigational device becomes available and/or the clinical 
investigation plan changes and this information can significantly affect a subject's future health and 
medical care, patients will be informed of the information and may be asked to sign a revised informed 
consent form. A subject may withdraw or discontinue participation at any time during the clinical 
investigation.  
 
 
 
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13. ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES 
13.1. Definitions  
The definitions provided in this section are based on the ISO 14155:2020. 
13.1.1. Adverse events 
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or 
not related to the investigational medical device and whether anticipated or unanticipated.  
This definition includes events related to the investigational medical device; events related to the 
procedures involved. For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
13.1.2. Serious adverse event 
The relevant serious adverse event (SAE) definitions for this clinical investigation include the following:  
a) death,  
b) serious deterioration in the health of the subject, users or other persons as defined by one or 
more of the following:  
a. a life-threatening illness or injury, or 
b. a permanent impairment of a body structure or a body function including chronic 
diseases, or  
c. In-patient or prolonged hospitalization, or 
d. in medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function,  
Planned hospitalization for a pre-existing condition, or a procedure required by the clinical 
investigation plan, without serious deterioration in health, is not considered a serious adverse event. 
13.1.3. Device deficiency 
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, usability, safety or performance.  
Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied by 
the manufacturer including labelling. This definition includes device deficiencies related to the 
investigational medical device. 
13.1.4. Adverse device effect 
An adverse device effect (ADE) is an adverse event related to the use of an investigational medical 
device.  
This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical 
device. And this definition includes any event resulting from use error or from intentional misuse of 
the investigational medical device. And this definition includes ‘comparator’ if the comparator is a 
medical device. 
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13.1.5. Serious adverse device effect 
A serious adverse device effect (SADE) is an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
13.1.6. Unanticipated serious adverse device effect 
An unanticipated serious adverse device effect (USADE) is a serious adverse device effect which by its 
nature, incidence, severity or outcome has not been identified in the current risk assessment. 
13.1.7. Anticipated serious adverse device effect 
Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity 
or outcome has been identified in the risk assessment. 
13.2. Causality  
This clinical investigation plan follows the MDCG 2020-10/1 with regards to the causality assessment. 
For the purpose of harmonizing reports, each SAE will be classified according to four different levels 
of causality:  
- 
Not related  
- 
Possible  
- 
Probable  
- 
Causal relationship  
The Sponsor and the investigators will use the following definitions to assess the relationship of the 
serious adverse event to the investigational device, the comparator or the investigation procedure. 
Not related: relationship to the device, comparator or procedures can be excluded when:  
- 
the event has no temporal relationship with the use of the investigational device or the 
procedures to application of the investigation device;  
- 
the serious adverse event does not follow a known response pattern to the medical device (if 
the response pattern is previously known) and is biologically implausible;  
- 
the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible - and reintroduction of its use (or increase of the 
level of activation/exposure), do not impact on the serious adverse event;  
- 
the event involves a body-site or an organ that cannot be affected ;the serious adverse event 
can be attributed to another cause (e.g. an underlying or concurrent illness/ clinical condition, 
an effect of another device, drug, treatment or other risk factors);  
- 
the event does not depend on a false result given by the investigational device used for 
diagnosis13, when applicable; 
- 
harms to the subject are not clearly due to use error;  
 
13 If an investigational device gives an incorrect diagnosis, the patient might, for example, receive an  
unnecessary treatment and incur all the risks that accompany that treatment, or might be incorrectly  
diagnosed with a serious disease. In other cases, the patient might not receive an effective treatment (thereby  
missing out on the benefits that treatment would confer), or might not be diagnosed with the correct disease  
or condition. 
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- 
the event depends on a false result given by the investigational device used for diagnosis14, 
when applicable; 
In order to establish the relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the serious event. 
Possible: the relationship with the use of the investigational device or comparator, or the relationship 
with procedures, is weak but cannot be ruled out completely. Alternative causes are also possible (e.g. 
an underlying or concurrent illness/ clinical condition or/and an effect of another device, drug or 
treatment). Cases were relatedness cannot be assessed or no information has been obtained should 
also be classified as possible.  
Probable: the relationship with the use of the investigational device or comparator, or the relationship 
with procedures, seems relevant and/or the event cannot reasonably explained by another cause, 
Causal relationship: the serious adverse event is associated with the investigational device, 
comparator, or with procedures beyond reasonable doubt when:  
- 
the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures;  
- 
the event has a temporal relationship with investigational device use/application or 
procedures;  
- 
the event involves a body-site or organ that  
• 
the investigational device or procedures are applied to;  
• 
the investigational device or procedures have an effect on;  
- 
the serious event follows a known response pattern to the medical device (if the response 
pattern is previously known);  
- 
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible);  
- 
other possible causes (e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment) have been adequately ruled out;  
- 
harm to the subject is due to error in use;  
- 
the event depends on a false result given by the investigational device used for diagnosis4, 
when applicable.  
In order to establish the relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the serious event. 
The Sponsor and the investigators will distinguish between the serious adverse events related to the 
investigational device and those related to the procedures (any procedure specific to the clinical 
investigation). An adverse event can be related both to procedures and the investigational device. 
Complications caused by concomitant treatments not imposed by the clinical investigation plan are 
considered not related. Similarly, several routine diagnostic or patient management procedures are 
 
14 If an investigational device gives an incorrect diagnosis, the patient might, for example, receive an unnecessary 
treatment and incur all the risks that accompany that treatment, or might be incorrectly diagnosed with a serious 
disease. In other cases, the patient might not receive an effective treatment (thereby missing out on the benefits 
that treatment would confer),or might not be diagnosed with the correct disease or condition. 
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applied to patients regardless of the clinical investigation plan. If routine procedures are not imposed 
by the clinical investigation plan, complications caused by them are also considered not related.   
In some particular cases the event may be not adequately assessed because information is insufficient 
or contradictory and/or the data cannot be verified or supplemented. The Sponsor and the 
investigators will make the maximum effort to define and categorize the event and avoid these 
situations. Where an investigator assessment is not available and/or the Sponsor remains uncertain 
about classifying the serious adverse event, the Sponsor should not exclude the relatedness; the event 
should be classified as “possible” and the reporting should not be delayed. 
Particular attention will be given to the causality evaluation of unanticipated serious adverse events. 
The occurrence of unanticipated events related to the use of the device could suggest that the clinical 
investigation places subjects at increased risk of harm than was to be expected beforehand. 
13.3. Severity 
Each serious adverse event will be classified according to three (3) levels of severity. The Sponsor and 
the investigators will use the following definitions to assess the severity of the serious adverse event: 
Mild: Awareness of signs or symptoms, but easily tolerated and are of minor irritant type causing no 
loss of time from normal activities. Symptoms do not require therapy or a medical evaluation; signs 
and symptoms are transient. 
Moderate: Events introduce a low level of inconvenience or concern to the participant and may 
interfere with daily activities, but are usually improved by simple therapeutic measures; moderate 
experiences may cause some interference with functioning 
Severe: Events interrupt the participant’s normal daily activities and generally require systemic drug 
therapy or other treatment; they are usually incapacitating. 
13.4. Foreseeable adverse events and anticipated adverse device effects 
Foreseeable adverse events and anticipated adverse devices effects as summarized in Section 4.2: 
• 
Toxic response  
• 
Thromboembolic event  
• 
(Re)Bleeding  
• 
Allergic reaction  
• 
Pain  
• 
New surgery  
• 
Infection  
• 
Blockage of artery or vein / ischemia of organs  
• 
Damage of organs and vessels 
• 
Pulsatile hematoma  
• 
Closing of intestinal track  
• 
Biloma 
Furthermore, the risk for encapsulated or rolled-up device was identified during the risk management, 
at a lower risk level/incidence. This risk will be further investigated in this clinical investigation by 
means of the 6-weeks follow-up imaging.   
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The events were identified in the risk analysis for GATT-Patch and were found acceptable after 
mitigation steps.  
13.5. Non-reportable adverse events 
N/A. This is a pre-market clinical investigation and all procedure- and device-related AEs will be 
reported for this clinical investigation.  
13.6. Reporting requirements 
13.6.1. Reporting adverse events 
Adverse event reporting will start at the time of surgery and ends after the last subject completed the 
clinical investigation. Adverse events that occur between the signing of the informed consent and the 
initiation of the surgery will thus not be reported on the eCRFs. Underlying diseases are not reported 
as adverse events, but any deterioration in severity will be reported. 
Adverse event information will be collected for all subjects. At every subject visit, the investigator will 
determine whether an adverse event has occurred since the last visit. All adverse events will be 
reported in the eCRF. The date of the initial event and the subsequent treatment will be documented.  
Adverse events will be evaluated and differentiated by: 
• 
Seriousness of the event 
• 
Causality of the event (in relation to the device or procedure) 
• 
Severity of the event 
13.6.2. Reporting device deficiencies 
All device deficiencies related to the identity, quality, durability, reliability, safety or performance of 
an investigational medical device will be documented throughout the clinical investigation and 
appropriately managed by the Sponsor. 
13.6.3. Reporting serious adverse events and serious adverse device effects 
Reporting requirements to the Sponsor and Regulatory authorities are summarized in the sections 
below.  
13.6.3.1. 
Reporting to the Sponsor/CRO 
The investigator will notify the Sponsor or its representative of any serious adverse events or serious 
adverse device effects, including device deficiencies that are declared as serious adverse events, 
immediately upon becoming aware of the event, by completing a “serious adverse event” form in the 
eCRF and immediately updating it once new information become available. In case the eCRF is not 
available when the investigator becomes aware of the event requiring immediate notification, the 
investigator will contact: 
Avania B.V. 
Prof. Bronkhorstlaan 10, Building 54  
3723 MB Bilthoven 
The Netherlands 
+31 30 229 2727 
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The following timelines will apply for reporting by investigator to the Sponsor or its representative: 
• 
Serious adverse events and serious adverse device effects within 24 hours; 
• 
Any other reportable events within 7 days (initial reports) or 15 days (follow-up report). 
13.6.3.2. 
Reporting to the Competent Authorities/Ethical Committees  
The reporting of any serious adverse event as defined in Section 13.1 has to be done immediately and 
not later than 2 calendar days after awareness by the Sponsor, for all reportable events, which indicate 
an imminent risk of death, serious injury, or serious illness and that requires prompt remedial action 
for other patients/subjects, users or other persons, or a new finding to it, or as required by the 
Competent Authority and/or Ethical Committee.  
For any other reportable events as defined in Section 13.1 or a new finding/update to it, the Sponsor 
must report the event to the Competent Authorities and/or Ethical Committee immediately and not 
later than 7 calendar days following the date of awareness by the Sponsor of the new reportable event 
or of new information in relation with an already reported event.  
In the Netherlands serious adverse events will be reported by the Sponsor (or its representative 
Avania) to the accredited Ethics Committee that approved the clinical investigation plan and 
Competent Authorities. 
Reporting Timelines to the Ethics Committee: 
The Ethics committee requires that all SAEs occurring in all participating sites in the Netherlands and 
all foreign countries will be reported. The timelines and reporting requirements are as follows: 
1. A serious adverse event which indicates an imminent risk of death, serious injury, or serious 
illness and that requires prompt remedial action for other patients/subjects, users or other 
persons or a new finding to it: immediately, but not later than 7 calendar days after awareness 
by the Sponsor of a new reportable event or of new information in relation with an already 
reported event. 
2. All other serious adverse events will be reported within 15 calendar days. 
Reporting to the Ethics Committee will occur by completing the Serious Adverse Event form in the 
ToetsingOnline portal (https://toetstingonline.ccmo.nl). These serious adverse events are 
automatically forwarded to the Ethics Committee.  
Reporting Timelines to the Competent Authority in the Netherlands: 
CCMO requires that all serious adverse events (device-related and not device-related) occurring in all 
participating sites in all participating countries are reported. 
The reporting timelines are as follows: 
1. A serious adverse event which indicates an imminent risk of death, serious injury, or serious 
illness and that requires prompt remedial action for other patients/subjects, users or other 
persons or a new finding to it: Immediately, within 2 working days, but not later than 4 
calendar days after awareness by the Sponsor of a new reportable event or of new 
information in relation with an already reported event. 
2. All other serious adverse events will be reported quarterly using serious adverse event line 
listing according to the reporting table of MEDDEV 2.7/3 SAE reporting guidelines. 
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Reporting to the Ethics Committee will occur by completing the Serious Adverse Event form in the 
ToetsingOnline portal (https://toetstingonline.ccmo.nl). These serious adverse events are 
automatically forwarded to the Competent Authority.  
13.7. Medical monitor 
A medical monitor, who is an independent physician not participating as a clinical investigator in the 
clinical investigation, will provide ongoing medical monitoring of incoming safety study data during 
the study conduct. Details of the medical monitor responsibilities are included in the Safety Data 
Handling Plan and include: 
• 
Maintaining ongoing assessment of the safety profile of the investigational device during the 
investigation.  
• 
Provide medical surveillance and evaluation of serious adverse events.   
13.8. Data monitoring committee 
A data monitoring committee (DMC) will monitor all emerging safety issues against pre-defined 
stopping rules of the clinical investigation. Any SAE or other safety concerns during the clinical 
investigation will be immediately referred, on a case-by-case basis, to the DMC for review against the 
stopping rules. A formal review of safety against the stopping rules will be conducted by the DMC 
during the enrolment pause when all subjects of the initial cohort (Stage I) are treated and have at 
least 2 week FU data available. The re-opening of recruitment will only be triggered by authorization 
from the DMC to proceed.  
The DMC’s composition, role, meeting schedule, functioning recommendations, and premature 
termination criteria will be described in a charter. This charter will be approved and signed by all 
parties before study start. 
The DMC will be independent from the Sponsor, the investigators or anyone involved in the clinical 
care of the study subjects. Members will not have scientific, financial or other conflict of interest 
related to the Sponsor or investigators. Potential DMC members will sign a non-conflict-of-interest 
statement in this regard. 
The DMC will function in accordance with applicable regulatory guidelines and the charter. 
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14. VULNERABLE POPULATION 
N/A. The subject population of this clinical investigation does not meet the criteria for a vulnerable 
population. 
15. SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL 
INVESTIGATION 
GATT Technologies BV reserves the right to terminate an investigator and/or investigational site for 
any of the reasons provided in Section 9.2. In addition, GATT Technologies BV may choose to suspend 
or prematurely terminate the clinical investigation for the following reasons: 
• 
Device deficiency or malfunction  
• 
Production limitation 
• 
Administrative decision  
GATT Technologies BV will promptly notify the investigators, Ethics Committees and Regulatory 
Authorities in this event and provide for appropriate therapy and follow-up for the subjects.  
In case of study termination or suspension, the investigators must inform the patients and may inform 
the personal physician of the patients to ensure appropriate care and follow-up is provided. In the 
case of a study suspension, patient enrollment must stop until the suspension is lifted. 
15.1. Stopping Rules 
The DMC may decide to temporarily halt the clinical investigation in case of safety concerns. The 
stopping rules are defined in the DMC Charter.  
16. PUBLICATION POLICY 
After closure of the clinical investigation, the results will be summarized in a Clinical Investigation 
Report, which will be submitted to the investigators, Ethics Committee(s) and appropriate regulatory 
authorities. This Clinical Investigation Report will include a summary of the results based on a 
statistical evaluation and clinical assessment.  
GATT Technologies BV may at any time publish the results of and information pertaining to the 
investigation subject only to compliance with regulatory requirements pertaining to patient protected 
health information. The conditions under which an investigator may publish results from this clinical 
investigation in any form are defined in detail in the clinical trial agreement. 
Irrespective of the outcome of the clinical investigation, within one year of the end of the clinical 
investigation or within three months of the early termination or temporary halt, GATT Technologies 
BV will submit to the Member States in which a clinical investigation was conducted a clinical 
investigation report.  
The clinical study will be registered in a public database (clinicaltrials.gov) and a summary of the results 
will be posted in this database once they become available. 
 
 
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17. BIBLIOGRAPHY  
1. 
Spotnitz, W.D., et al., The SPOT GRADE: a new method for reproducibly quantifying surgical 
wound bleeding. Spine, 2018. 43(11): p. E664-E671. 
2. 
Wells, C.I., et al., Haemostatic Efficacy of Topical Agents During Liver Resection: A Network 
Meta-Analysis of Randomised Trials. World Journal of Surgery, 2020: p. 1-9. 
3. 
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DHF-01-QR-021 (DOC-589) Ver. 4
Approved By:
(CO-20289) DHF-01-QR-021 - CIP
Description
DHF-01-QR-021 - Clinical Safety and Performance of GATT-Patch in Open Liver
Justification
Update of document
Assigned To:
Initiated By:
Priority:
Impact:
Stuart Head
Marlie Pennings
Low
Minor
Version History:
Author
Effective Date
CO#
Ver.
Status
Stuart Head
September 24, 2021 5:55 PM CEST
CO-20289
4
Published
Marlie Pennings
September 23, 2021 2:46 PM CEST
CO-20288
3
Superseded
Marlie Pennings
September 23, 2021 2:11 PM CEST
CO-20287
2
Superseded
Marlie Pennings
September 23, 2021 12:28 PM CEST
CO-20286
1
Superseded
Rosa Felix Lanao
January 19, 2021 9:45 AM CET
CO-20100
0
Superseded
Proprietary & Confidential - Page 1 of 1 - Uncontrolled if Printed
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