A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
Phase: NA
Conditions: Gastrostomy
Sponsor: CoapTech

 
 
 
 
 
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A single-center, feasibility study to evaluate the use and safety of the Percutaneous 
Ultrasound Gastrostomy technique 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator:  
Amol Mujoomdar, MD FRCPC 
 
 
 
 
Division Head for Interventional Radiology 
 
 
 
 
London Health Sciences Centre 
NCT03575754 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
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Table of Contents 
 

 
 
 
 
 
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Table of Contents 
2 
List of Tables 
5 
List of Figures 
5 
List of Abbreviations 
6 
Protocol synopsis 
7 
Introduction 
12 
Background 
12 
Purpose 
12 
Study Objectives 
13 
Primary Objectives 
13 
Key Secondary Objectives 
13 
Exploratory Objectives 
14 
Investigational Plan 
14 
Study Design 
14 
Study Design Timeline 
15 
Rationale of Study Design 
16 
Risks and Benefits 
16 
Population 
17 
Inclusion Criteria 
17 
Exclusion Criteria 
17 
Method of Assigning Subjects to Treatment Groups 
18 

 
 
 
 
 
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Procedural Team 
18 
Demographics 
18 
Medical History 
18 
Height & Weight 
19 
Description of CoapTech Device 
20 
Internal Balloon Catheter 
20 
External Handheld Magnet 
20 
Guidewire 
20 
Treatment per Protocol 
22 
Clinical Workflow of PUG Procedure 
23 
Assessments 
26 
Efficacy Assessment 
26 
Other Assessments 
26 
Procedure Failures 
26 
Resource Utilization 
26 
Clinical Team Survey 
26 
Subject Evaluation 
26 
Physical Exam 
26 
Vital Signs 
27 
Clinical Laboratory Tests 
27 
Pregnancy Testing 
27 

 
 
 
 
 
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Concomitant Medications, Therapies, and Interventions 
28 
Adverse Event Assessments 
28 
Adverse Event 
28 
Serious Adverse Event 
29 
Pregnancy Reporting 
29 
Ethical Considerations 
30 
Institutional Review Board 
30 
Informed Consent 
30 
Protocol Adherence 
31 
Protocol Amendments 
31 
Data Handling and Record Keeping 
31 
Administrative Considerations 
32 
Investigators and Study Administrative Structure 
32 
Institutional Review Board Approval 
32 
Ethical Conduct of the Study 
33 
Patient Information and Consent 
33 
Patient Confidentiality 
34 
Case Report Forms and Study Records 
34 
Data Monitoring Committee 
35 
Protocol Violations/Deviations 
35 
Premature Closure of the Study 
36 

 
 
 
 
 
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Access to Source Documentation 
36 
Data Generation and Analysis 
36 
Retention of Data 
36 
Financial Disclosure 
37 
Publication and Disclosure Policy 
37 
References 
38 
 
 
 
Appendices to Protocol: 
 
I. 
Case Report Forms: 
 
i) 
Baseline Screening Form 
ii) 
Prior and Concomitant Medications Form 
iii) 
Immediate Post-Procedure Assessment Form 
iv) 
Day 2 Assessment Form 
v) 
Final Assessment Form 
 
 
II. 
Data Safety Monitoring Plan 
 
 
 
 
 
 

 
 
 
 
 
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List of Tables 
Table 1 
Page 15 
Calculated Enrollment Required for Prospective Comparison 
Study of PUG vs PEG 
Table 2 
Table 3 
Page 27 
Page 28 
Assessments for Physical Examination 
Adverse Events Scoring System 
 
 
 
List of Figures 
Figure 1 
Page 15 
Study Design Timeline 
Figure 2 
Page 21 
Device components and description 
Figure 3 
Page 21 
Internal Balloon Catheter and External Handheld Magnet 
Figure 4 
Page 23 
Clinical workflow of PUG procedure 
 
 

 
 
 
 
 
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List of Abbreviations 
 
AE 
Adverse Event 
BMI 
Body Mass Index 
BP 
Blood Pressure 
CRF 
Case Report Form 
DSMB 
Data Safety Monitoring Board 
ECG 
Electrocardiogram 
EHM 
External Handheld Magnet 
FDA 
United States Food & Drug Administration 
GCP 
Good Clinical Practice 
GI 
Gastrointestinal 
hCG 
Human Chorionic Gonadotropin 
HR 
Heart Rate 
IBC 
Internal Balloon Catheter 
IR 
Interventional Radiology 
REB 
Research Ethics Board 
LAR 
Legally Authorized Representative 
PEG 
Percutaneous Endoscopic Gastrostomy 
PUG 
Percutaneous Ultrasound Gastrostomy 
SAE 
Serious Adverse Event 
 
 

 
 
 
 
 
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Protocol Synopsis 
 

 
 
 
 
 
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Protocol 
Version 1.0 
Title 
A single-center, feasibility study to evaluate the use and safety 
of the Percutaneous Ultrasound Gastrostomy technique 
Brief title 
Percutaneous Ultrasound Gastrostomy technique 
Sponsor 
CoapTech 
Investigation Type 
Medical Device / Procedure 
Study Type 
Interventional 

 
 
 
 
 
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Purpose and 
Rationale 
The purpose of this study is to evaluate the performance, 
safety and tolerability of the Percutaneous Ultrasound 
Gastrostomy (PUG) procedure that utilizes a novel device in 
conjunction with widely available ultrasound technology. The 
CoapTech device consists of a gastric catheter with a balloon 
enclosing a magnetic bar at its distal end and an external, 
handheld magnet. The gastric catheter is passed through the 
mouth and into the stomach. The external magnet is then 
used to maneuver the balloon to the desired location, with 
feedback and guidance from real-time ultrasound 
visualization. With the external magnet coupled, or “coapted”, 
to the magnet within the gastric tube balloon, the gastric tube 
balloon will be in place within the stomach pushing it flush 
against the internal abdominal wall. This allows for complete 
ultrasound visualization from skin-to-stomach, facilitating safe 
percutaneous puncture into the stomach and guidewire-
assisted placement of the gastrostomy tube.  
In this study, subjects will have the procedure performed to 
assess the performance of the device and aspects of the 
technique as well as determining safety and tolerability. The 
phased study approach is as follows: 
• 
Phase 1: 5 subjects, performed in specialty suite 
• 
Phase 2: up to additional 20 subjects, performed at the 
bedside (or in specialty suite, if appropriate) 
• 
Phase 3: TBD (will require protocol amendment) 
More than 200,000 gastrostomy tubes are placed each year in 
the United States, and that number is expected to increase as 
the proportion of the population that is elderly grows (Roche et 
al 2003, Goldberg et al 2005, Lynch et al 2004). Percutaneous 
endoscopic gastrostomy (PEG) has become the most 
common method for placement of a gastrostomy tube. This 
requires the use of specialized equipment and the availability 
of physicians specifically trained in this procedure. The 
CoapTech device and the Percutaneous Ultrasound 
Gastrostomy (PUG) technique are designed to reduce the 
need for specialized equipment as well as to reduce the 
training required to perform the procedure.  

 
 
 
 
 
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Primary Objective(s) 
To assess the safety and feasibility of gastrostomy tube 
placement using the PUG technique and the CoapTech 
device.  The primary outcome of interest will be number and 
severity of device-related adverse events.     
Any adverse events during the immediate procedural and 
post-procedural period with a score of 3 or greater (“serious”) 
will be considered unsafe.  Of that set, any adverse safety 
events during the immediate procedural and post-procedural 
period with a “relatedness to intervention” score of 3 or greater 
(“probably related”) will be considered device-related.  See 
Table 3. 

 
 
 
 
 
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Secondary 
Objectives 
 
1) While acknowledging that the study is underpowered, to 
perform a preliminary direct comparison of the following 
between the PUG placement and a retrospective cohort of 
matched controls who undergo gastrostomy placement 
using the percutaneous radiologic gastrostomy (PRG) 
push gastropexy technique.  
a) Serious complication rate: a composite rate inclusive of 
inadvertent puncture of important structures, damage 
to structures requiring surgical repair and development 
of infectious complications during the immediate post-
procedure period. Important structures are defined a 
priori as liver, larger blood vessels (that require 
operative repair or result in significant blood loss in the 
opinion of the operator), small or large bowel, spleen, 
etc.. 
b) Serious adverse events, individually described as:  
i) 
Misplacement harm 
ii) Infection (Sepsis, Peritonitis) 
iii) Tissue / Organ Damage 
iv) Requirement for Salvage Surgery and which 
type(s) 
v) Other 
2) To describe the preliminary rate of other complications 
during the immediate procedural period between the PUG 
placement and a historical cohort of matched controls who 
underwent gastrostomy placement using the PRG 
technique. 
a) Tube rupture 
b) Retained foreign body due to procedure 
3) To compare the preliminary cost and operational factors 
during the immediate procedural period and overall 
hospital stay between the PUG placement and a 
retrospective cohort of matched controls who undergo 
gastrostomy placement using the PRG technique, 
including: 

 
 
 
 
 
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a) Length of stay after gastrostomy insertion 
b) Total variable direct costs by cost category (e.g. 
medications, suite time, etc.) 
4) To assess preliminary human factors properties through 
immediate procedural period data including: 
a) Overall procedure time 
b) Physician feedback via surveys on usage properties 
 
Study Design 
Single-center, non-randomized, non-blinded feasibility and 
safety pilot study 
Population 
The study population will consist of male and female patients 
(≥18 years old) admitted to the hospital and in whom it has 
been determined by the clinical care team that gastrostomy 
tube placement is indicated for the administration of nutrition 
or medications. 
Comparator 
The comparator group will consist of a matched historical 
cohort of patients who had gastrostomy tube placement 
performed using the PRG procedure 
Inclusion Criteria 
• 
Informed consent must be obtained before any study-
specific assessment is performed   
• 
Male or female ≥18 years of age 
• 
BMI ≤30, AND BMI 20 
• 
Indication for gastrostomy tube placement determined 
to be present by the primary clinical care team 
• 
Patient determined to be an appropriate candidate for 
gastrostomy by the study team 
• 
Women of childbearing potential must have negative 
serum or urine pregnancy test during the current 
hospitalization 

 
 
 
 
 
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Exclusion Criteria 
• 
BMI > 30, OR BMI < 20 
• 
Temperature ≥ 38 C  
• 
Systolic BP < 100 or > 180 mmHg 
• 
Heart Rate < 50 or > 110 
• 
Presence of a contraindication to being in proximity to 
a magnet (e.g. pacemaker). 
• 
History of prior gastrostomy, gastrectomy (partial or 
complete), or abdominal trauma or upper-abdominal 
surgery.  
• 
Patients with hematocrit <25%, or a history of blood 
transfusion within the 14 days prior to screening, or 
active life-threatening GI bleeding.   
• 
Pregnant or nursing (lactating) women, where 
pregnancy is defined as the state of a female after 
conception and until the termination of gestation, 
confirmed by a positive hCG laboratory test. 
• 
Involvement in other investigational trials within 30 
days prior to screening.  
• 
Any other medical condition(s) that may put the patient 
at risk or influence study results in the investigator’s 
opinion, or that the investigator deems unsuitable for 
the study. For example, large or collapsed transverse 
colon overlapping anterior stomach on pre-existing 
radiographic scan.  
• 
Anticipated discharge <36 hrs from gastrostomy  
Investigational and 
Reference Therapy 
Investigational: Placement of gastrostomy tube using the 
CoapTech device and the PUG technique 
Reference: A historical cohort of matched patients who 
underwent PRG placement. 

 
 
 
 
 
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Efficacy 
Assessments 
Primary efficacy assessment: 
Describing the feasibility and safety of gastrostomy tube 
placement using the PUG technique and the CoapTech 
device.  
 
Key preliminary and secondary efficacy assessments  
• 
Description of occurrences of procedure termination 
o Termination according to protocol 
o Termination due to other reasons 
• 
Description of any reasons for delays in performance 
of procedure 
• 
Determination of overall rate of any adverse events 
and relatedness-to-device 
• 
Description of occurrences of inadvertent puncture of 
vital organs during performance of procedure  
• 
Description of occurrences of infectious complications 
• 
Description of occurrences of salvage surgery 
performed due to complication of procedure 
• 
Description of occurrences of requirements for 
sedation and analgesia during performance of 
procedure 
Patient Assessments 
• 
Physical examination 
• 
Vital signs 
• 
Height and weight 
• 
Calculation of BMI 
• 
Abdominal circumference  
• 
Laboratory evaluations 
• 
Electrocardiogram, if appropriate 
• 
Gastrostomy tract depth (measured under ultrasound 
during procedure) 

 
 
 
 
 
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Other assessments 
• 
Preliminary healthcare resource utilization (Costs) 
o Direct costs of procedure 
o Environment (e.g. Suite time, etc.) 
o Laboratory costs 
o Medication cost 
o Provider costs 
o Device costs (estimated) 
• 
Length of total ICU and length of total hospital stay 
after determination made to have gastrostomy tube 
placed 
• 
Indications for gastrostomy placement 
Data Analysis 
The primary safety variables are the number and severity of 
enrolled subjects who have a serious, device-related adverse 
event during placement of a gastrostomy tube using the PUG 
procedure. 
 
The primary feasibility/efficacy variable is the number of 
enrolled subjects who have successful placement of a 
gastrostomy tube using the PUG procedure. 
 
Key secondary efficacy variables will be assessed by using 
common descriptive statistics to a historical cohort of matched 
subjects who have undergone PRG placement.  
 
Data assessments are planned at the end of Phase 1 (n=5), 
after the 7th subject in Phase 2 (n=12), and at the end of 
Phase 2 (n≤25). 
 
 
 

 
 
 
 
 
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Introduction 
 
Background 
Gastrostomy feeding is an established means of delivering adequate nutrition to patients 
with an inability to meet their metabolic requirements due to inadequate oral intake. 
Additionally, the gastrostomy tube can be utilized for medication administration in 
patients unable to otherwise tolerate oral intake. Traditionally, placement of gastrostomy 
tubes has been performed endoscopically, radiologically or by either laparoscopic or 
open surgical techniques. More than 200,000 gastrostomy tubes are placed each year in 
the United States, and that number is expected to increase as the proportion of the 
population that is elderly grows (Roche et al 2003, Goldberg et al 2005, Lynch et al 
2004).  
 
Previous studies have failed to identify a clearly superior technique for placement of 
feeding tubes (Bravo 2016, Yuan 2016). Percutaneous endoscopic gastrostomy (PEG) 
was first described by Gauderer et al. in 1980 in a case series of 12 children as an 
alternative to laparotomy in high-risk patients (Gauderer 1980). There is a high overall 
success rate of PEG placement at 95-100% (Itkin 2011). Percutaneous endoscopic 
gastrostomy (PEG) has become the most common method for placement of a 
gastrostomy tube. This requires the use of specialized equipment and the availability of 
physicians specifically trained in this procedure. The number of procedures performed 
yearly to place feeding tubes is expected to rise as the population ages and as some 
treatments have resulted in some diseases become chronic states rather than invariably 
fatal conditions. 
 
Challenges to performance of gastrostomy tube placement include the requirement for 
specialized equipment, specialized areas designated to have this procedure performed 
as well as the need for proceduralists who are specifically trained in this technique.  
 
The CoapTech device was developed in an effort to reduce the complicated 
requirements associated with other techniques of gastrostomy placement so that when 
clinically indicated the procedure can be performed in a safe and timely manner by a 
wide range of clinicians with various training backgrounds. 
 
 
 

 
 
 
 
 
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Purpose 
This is a single-center, non-randomized, non-blinded feasibility study to evaluate the 
performance, safety and tolerability of the Percutaneous Ultrasound Gastrostomy (PUG) 
procedure that utilizes a novel device in conjunction with widely available ultrasound 
technology. The procedure will be performed in up to 25 eligible subjects. Patients will 
be followed for 2 days following performance of PUG to assess for potential 
complications. If the patient remains hospitalized they will be assessed at date of 
discharge or Day 30 (whichever is earlier) for potential complications. 
 
Study Objectives 
Primary Objective 
• 
To assess the feasibility and safety of gastrostomy tube placement using the 
PUG technique and the CoapTech device.  The primary outcome of interest will 
be number and severity of device-related adverse events.    Any adverse events 
during the immediate procedural and post-procedural period with a score of 3 or 
greater (“serious”) will be considered unsafe.  Of that set, any adverse safety 
events during the immediate procedural and post-procedural period with a 
“relatedness to intervention” score of 3 or greater (“probably related”) will be 
considered device-related.  See Table 3 for scoring system details.   
 
Key Secondary Objectives 
• 
Description of occurrences of procedure termination 
o Termination according to protocol 
o Termination due to other reasons 
• 
Description of any reasons for delays in performance of procedure 
• 
Determination of categorical rates of serious complications during the immediate 
procedural period of 48 hours 
o Serious adverse events include but are not limited to the following: 
▪ 
inadvertent puncture of important structures 
▪ 
damage to structures requiring surgical repair and  
▪ 
development of infectious complications.  
o Important structures are defined a priori as liver, larger blood vessels (that 
require operative repair or result in significant blood loss in the opinion of 
the operator), or local organs including small or large bowel, spleen, 
colon, etc. 
o Serious adverse events will be described as:  
▪ 
Misplacement harm 
▪ 
Infection (Sepsis, Peritonitis) 
▪ 
Tissue / Organ Damage 
▪ 
Requirement for Salvage Surgery and which type(s) 
▪ 
Other 
• 
Description of occurrences of inadvertent puncture of vital organs during 
performance of procedure  

 
 
 
 
 
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• 
Description of occurrences of infectious complications 
• 
Description of occurrences of salvage surgery performed due to complication of 
procedure 
• 
Description of occurrences of requirements for sedation and analgesia during 
performance of procedure 
• 
Description of reasons for delays in performance of the procedure. 
 
Exploratory Objectives 
• 
To evaluate the costs associated with performance of gastrostomy placement 
using the PUG technique 
o Direct costs of procedure 
o Environment (e.g. Suite time, etc.) 
o Laboratory costs 
o Medication costs 
o Provider costs 
o Equipment costs (other than device) 
• 
Description of length of total ICU and hospital length-of-stay after determination 
made to have gastrostomy placed 
• 
To assess satisfaction of the clinical care team with the performance of the 
procedure and human factors of the device. 
 
Investigational Plan 
 
Study Design 
 
After assessing eligibility during the screening period, patients who meet the study 
inclusion and exclusion criteria will be eligible to have gastrostomy tube placement using 
the PUG technique with the CoapTech device. Proceduralists who have been trained in 
the performance of the technique will be contacted to arrange a time to have the 
procedure performed.  
 
 

 
 
 
 
 
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Figure 1. Study Design Timeline 
 
 
 
 
 

 
 
 
 
 
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Rationale of Study Design 
 
A single arm, prospective, feasibility and safety pilot study was chosen for this first in-
human clinical trial of the PUG procedure. If the study were designed to show reduced 
rates of complications for the PUG procedure compared to PRG then an unachievable 
number of subjects would be required to be enrolled. A table was generated 
demonstrating the number of patients required to show that there is a reduction in 
complications from 3 to 1%. In order to reject a null hypothesis that there is no reduction 
in complications of the PUG procedure, 1000 subjects would be required to be enrolled 
with 500 subjects in each arm of the trial. A trial of this size would not be a reasonable 
first use in human study. The current study will utilize a matched retrospective cohort of 
patients who had gastrostomy tube placement performed using the PRG procedure for 
comparison.  
 
The 25-patient study is divided into two phases. The five patients were selected for 
phase 1 (n=5) as it should allow for sufficient experience with the PUG technique in a 
controlled environment that will allow for immediate assessment with fluoroscopy or 
conversion to PRG if needed. With adequate experience from Phase 1, Phase 2 will 
then allow for some of the PUG procedures to be performed outside of the interventional 
radiology suite to assess the unique capability of the PUG procedure. 
 
Table 1. Enrollment Required for Prospective Comparison of PUG vs PEG 
 
 
 
Risks and Benefits 
 
The potential risks of the proposed PUG procedure include those that exist in the current 
standard of care:  infection, bleeding and unwanted damage to organs surrounding the 
stomach.  Similarly, as with any gastrostomy approach, there are anesthesia risks. The 
FDA acknowledged the PUG procedure’s safety factors as technically equivalent to 
PEG, but also identified the new risk of magnetic pressure applied to the stomach 
tissues during the PUG procedure.  Theoretically, excessive pressure on the stomach 
wall caused by magnetic coaptation forces could cause injury to the stomach and 
surrounding tissues including abrasions, bruising and ischemia.  These risks are 
considered minimal based on prior data from live canine, bench top, and cadaver tests, 
which demonstrated no clinically significant tissue damage. In terms of anesthesia risks, 

 
 
 
 
 
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PUG is expected to be performed under procedural/moderate sedation, but this level 
may be increased based upon clinical indication. Therefore, the anesthesia risk for PUG 
is considered to be no different (i.e., greater) than current gastrostomy (PEG or PRG) 
procedures.  
 
The benefits for the patient of using PUG are potentially significant. Enabling ultrasound 
visualization categorically increases safety with PUG, as opposed to PEG, which is 
performed with a “blind stick” (via transillumination and palpation) or percutaneous 
radiology-guided gastrostomy (PRG) which only uses projectional fluoroscopy for 
transgastric needle guidance. With real-time ultrasound visualization, the operator will be 
able to directly visualize critical structures (Liver, colon, inferior epigastric arteries, etc) to 
ensure they are not inadvertently punctured. Additionally, the PUG balloon catheter is 
provided as a sterile, single-use disposable. This eliminates reprocessing risks common 
to endoscopy-based procedures. Finally, unlike PRG & PEG, this technique for 
gastrostomy tube insertion could be performed bedside and would not require critically ill 
patients to leave the safety of the ICU department to have the tube inserted, as it 
currently required. 
 
 
 

 
 
 
 
 
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Population 
 
The study population will consist of male and female patients (≥18 years old) admitted to 
the participating study site and in whom the primary clinical team has determined that a 
gastrostomy tube should be placed. The study will focus on patients with a BMI of 20-30 
to avoid complications associated with extremes in body habitus.  
 
Inclusion Criteria 
 
Patients eligible for inclusion in this study have to fulfill all of the following criteria:  
• 
Informed consent must be obtained before any study-specific assessment is 
performed   
• 
Male or female ≥18 years of age 
• 
20≤ BMI ≤30 
• 
Indication for gastrostomy tube placement determined to be present by the 
primary clinical care team 
• 
Patient determined to be an appropriate candidate for gastrostomy by the study 
team 
• 
Women of childbearing potential must have negative serum or urine pregnancy 
test during the current hospitalization 
 
Exclusion Criteria 
 
Patients fulfilling any of the following criteria are not eligible for inclusion in this study.  
• 
BMI > 30, or BMI < 20 
• 
Temperature ≥ 38 C  
• 
Systolic BP < 100 or > 180 mmHg 
• 
Heart Rate < 50 or > 110 
• 
Presence of a contraindication to being in proximity to a magnet (e.g. 
pacemaker). 
• 
History of prior gastrostomy, gastrectomy (partial or complete), or abdominal 
trauma or upper-abdominal surgery. 
• 
Patients with hematocrit <25%, or a history of blood transfusion within the 14 
days prior to screening, or active life-threatening GI bleeding.   
• 
Pregnant or nursing (lactating) women, where pregnancy is defined as the state 
of a female after conception and until the termination of gestation, confirmed by a 
positive hCG laboratory test. 
• 
Involvement in other investigational trials within 30 days prior to screening. 
• 
Any other medical condition(s) that may put the patient at risk or influence study 
results in the investigator’s opinion, or that the investigator deems unsuitable for 

 
 
 
 
 
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the study. For example, large or collapsed transverse colon overlapping anterior 
stomach on pre-existing radiographic scan.  
• 
Anticipated discharge < 36 hours from gastrostomy. 
 
Method of Assigning Subjects to Treatment Groups 
All patients enrolled in the study will have the PUG procedure performed. There is no 
prospectively enrolled comparator group. 
 
Procedural Team 
 
The PUG procedure will be performed by a member of the study team trained to perform 
the procedure. The proceduralists consist of physicians trained in either critical care or 
interventional radiology (IR). The proceduralist assigned will be based on scheduling and 
availability of the entire proceduralist team. Patients consenting to the study who reside 
on general medical floors will have PUG performed in the IR or specialty suites.   
 
 
Demographics 
 
Patient demographic information including sex, date of birth, and race will be collected 
prior to the patient having the PUG procedure performed. 
 
Medical History 
 
Medical history will be recorded in the Case Report Forms (CRFs). Important medical 
events, illnesses and medications will be recorded on the appropriate CRF pages. Any 
existing medical condition present prior to performance of the PUG procedure will be 
reported as medical history. 
 
Height & Weight 
 
Height and weight will be recorded for all patients.  
 
 
 

 
 
 
 
 
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Description of CoapTech Device 
 
The device consists of several components (a balloon catheter, an external handheld 
magnet, and a guidewire), which are described individually below (Fig. 2 and Fig. 3). 
 
Internal Balloon Catheter (IBC) 
 
The disposable internal component of the device consists of a balloon catheter 
(16 Fr, polyurethane) that is placed through the patient’s mouth, down through the 
esophagus, and into the stomach (Fig. 4). At the catheter’s distal end, the balloon 
encloses a bar magnet (dimensions, 0.150” diameter x 1.750” length). The proximal end 
of the tube is fitted with a luer lock port through which a spring-tempered stainless steel 
wire stylet is installed along the length of the tubing. The stylet aids in manual placement 
of the IBC into the stomach by preventing curling of the tube upon itself. The luer lock 
port is used during the procedure to introduce fluid into the ultra-thin polyurethane 
balloon that surrounds the magnet at the distal end of the catheter. The balloon 
surrounding the magnet can be seen on ultrasound only when it is in direct apposition to 
the wall of the stomach during coaptation.  Any air between the ultrasound probe and the 
fluid-filled balloon prevents identification of the balloon. 
 
External Handheld Magnet 
 
The non-disposable component of the device is the external handheld magnet 
(EHM), consisting of a large magnet enclosed in a plastic housing shaped for ergonomic 
handling. To maintain sterility, the EHM is protected by a disposable sterile cover 
(provided with kit).  The EHM is placed on that patient’s abdominal wall to attract the 
magnetic tip of the IBC to the anterior stomach. 
 
Guidewire 
 
The guidewire is composed of a plastic dispenser loaded with a 0.031-inch 
diameter, 261-cm long flexible (nickel titanium and stainless steel) wire. In its natural 
state, the tip of the guidewire is coiled into a pigtail shape with an approximate 1.2-cm 
diameter and two full rotations. The guidewire fits through a standard 18G needle.  
 
 
 

 
 
 
 
 
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Figure 2. Device components and description 
 
 
 
Figure 3. Internal Balloon Catheter (left) and External Handheld Magnet (right) 
 
 

 
 
 
 
 
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Treatment per medical protocol 
 
1. STOP if any contraindications to percutaneous gastrostomy or magnetic fields 
(such as a pacemaker) are present. 
2. Insert a temporary feeding tube using standard gastric tube insertion technique(s) 
and confirm placement below the ribs with auscultation. If unable to complete, 
STOP.   
3. Remove the balloon catheter from sterile packaging. Lubricate the catheter 
liberally. Insert the catheter orally using standard gastric tube insertion 
technique(s). If sensing resistance, STOP. Once completed, remove the inner 
stylet. 
4. Prepare the site according to the surgical guidelines of your institution.  
5. Prep the handheld magnet by placing it in a sterile drape or transducer cover.    
6. Confirm catheter placement in stomach by moving the handheld magnet along the 
abdomen below the ribs and feeling for coaptation with the balloon catheter (i.e. 
trans-cavity magnetic attraction and alignment). If coaptation is not obvious, fill the 
balloon (approximately 25mL) with methylene blue dyed sterile water or saline and 
attempt to find the balloon catheter by ultrasound. If unable to achieve coaptation 
or confirm by ultrasound, STOP. NOTE: time under coaptation is expected to be 
less than 10 minutes.  
7. Insufflate the stomach with air using the preplaced temporary gastric tube. If 
unable to appropriately insufflate, STOP. 
8. If the balloon has not been inflated under prior steps, infuse approximately 25mL 
of methylene blue dyed sterile water or saline into the balloon catheter.  If needed, 
first gently aspirate the balloon catheter to remove air from the balloon. NOTE: 
adding more than 35mL of fluid into the balloon catheter may impact visualization. 
9. Use ultrasound to visualize the balloon. To enhance visualization, agitate the fluid 
by pressing repeatedly on the external tubing or pumping the syringe (up to 5mL 
of fluid in and out). If unable to visualize the balloon on ultrasound, STOP. 
10. For gastrostomy tract formation, make minor adjustments to balloon location using 
the handheld magnet, as needed. Verify with ultrasound that no bowel, viscera or 
vessels are overlaying the stomach at the planned gastrostomy tract. Note the 
balloon depth on ultrasound to estimate the gastrostomy tract length. Record the 
planned tract length. If unable to identify a safe tract site, STOP. 
11. Inject local anesthetic at the planned gastrostomy site if needed for patient comfort. 
Create a gastrostomy tract using an access needle attached to a syringe. Under 
real-time ultrasound guidance, advance the needle to target the balloon’s center 
while gently aspirating. Confirm placement in balloon by aspirating blue dyed water 
or saline into the syringe. If unable to aspirate, STOP. 
12. Hold the access needle in position while removing the syringe. 
13. Insert curled end of guidewire into the access needle. To achieve this, pull the 
guidewire back into the feeder tip, which will temporarily straighten the guidewire 

 
 
 
 
 
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tip. Insert until resistance is relieved, or approximately 5 cm beyond the needle. If 
excessive resistance is present, STOP.  
14. Gently remove the needle, leaving the guidewire in place.   
15. Deflate the balloon by aspirating all fluid from the external port.   
16. Remove the handheld magnet and place it safely away from the patient and other 
magnetic material.   
17. Gently advance the guidewire while simultaneously retracting the balloon catheter 
from the mouth. This should be done slowly and at equal rates (as much as 
possible). Upon completion of this step, the curled guidewire tip will have exited 
the mouth with the balloon catheter, with the other end of the guidewire exiting via 
the gastrostomy tract. If coupling of the guidewire and balloon is lost during this 
process, remove the guidewire from the stomach and STOP.   
18. In order to push the gastrostomy tube over the guidewire, cut off the curled end of 
the guidewire at the shaded section. Discard the curl and balloon catheter. 
CAUTION: cutting outside the shaded region could cause unraveling of the 
guidewire.  
19. Follow standard percutaneous gastrostomy PUSH (Sachs-Vine) technique, with 
gastrostomy PUSH kit. 
20. In situations where coaptive ultrasound has identified a safe gastrostomy tract 
region, and the PUSH technique is ultimately not feasible or fails, gastrostomy tube 
placement may be completed using gastropexy. Using a gastropexy kit, place 
gastropexy anchors followed by standard insertion technique. 
 
Figure 4. Clinical workflow of PUG procedure 
 
Step 1. IBC insertion: Internal 
balloon catheter (IBC) is inserted 
orally down the esophagus using 
standard procedures for orogastric 
tube insertion. Stomach is insufflated.  

 
 
 
 
 
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Step 2. Coaptation: External magnet 
(displayed here as rounded white 
structure) pulls stomach against the 
abdominal wall by magnetic force.  
Step 3. Visual confirmation: Balloon 
is filled with saline and a safe 
gastrostomy tract location is identified 
through ultrasound of the stomach 
and balloon. Moving the external 
magnet will make minor adjustments 
to the position of the IBC, to avoid 
certain anatomy.  
Step 4. Puncture and coupling: 
Needle and guidewire are inserted 
through stomach with ultrasound 
visualization and coupled with IBC 
through pigtail mechanism. 
Step 5+.  The final steps of the PUG procedure are consistent with those of the 
Sacks-Vine technique used in the PEG procedure. 
 
 
 
 

 
 
 
 
 
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Assessments 
 
Efficacy Assessment 
 
The primary safety variables are the number and severity of enrolled subjects who have 
a serious, device-related adverse event during placement of a gastrostomy tube using 
the PUG procedure. 
 
The primary feasibility/efficacy variable is the number of enrolled subjects who have 
successful placement of a gastrostomy tube using the PUG procedure. 
 
 
Other Assessment – Procedure Failures 
 
In cases where the PUG procedure fails to have successful placement of a gastrostomy 
tube, reasons for the failure will be determined. These reasons will be divided into those 
pertaining to the procedure/device itself and those reasons external to the 
procedure/device. 
 
Other Assessment – Resource Utilization 
 
The costs associated with performance of gastrostomy placement using the PUG 
technique will be assessed. This includes: 
o Direct costs of procedure 
o Environment (e.g. Suite time, etc.) 
o Laboratory costs 
o Medication costs 
o Provider costs 
o Equipment costs (other than device) 
 
Other Assessment – Clinical Team Survey 
 
A brief survey will be administered to the primary clinical team to assess satisfaction with 
the procedure and provide human factors feedback. 
 
Subject Evaluation 
 
Physical Exam 
A physical examination will be performed by the study team at baseline, immediately 
following recovery from the PUG procedure and at Day 2 following PUG procedure. If 

 
 
 
 
 
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the patient remains in the hospital longer than 2 days then another physical examination 
will be performed at the time of discharge or on Day 30, whichever comes first.  
 
Physical examinations will include a review of the patient’s general appearance, as well 
as evaluation of the following body systems (see Table 2). Any abnormalities observed 
at baseline should be recorded on the Medical History Form of the Case Report Form 
(CRF). Any post-baseline new or worsening abnormalities should be recorded as an 
Adverse Event (AE).  
 
Table 2 Assessments for Physical Examination 
Assessment 
Assessment 
General appearance 
Chest and lungs 
Head and neck 
Heart 
Eyes 
Abdomen 
Ears 
Extremities 
Nose 
Nervous System 
Throat 
Skin 
 
Vital Signs 
Pulse rate and systolic and diastolic blood pressure will be measured and recorded on 
the CRF at baseline, immediately prior to the PUG procedure, during the PUG procedure 
according to institutional norms, immediately following recovery from the PUG 
procedure, at Day 2 assessment and at the final assessment if the patient remains 
hospitalized (up to Day 30). 
 
Clinical Laboratory Tests 
Serum chemistry and hematology blood tests are performed as per usual care protocol. 
Results of these tests will be noted in the CRFs. 
 
Electrocardiogram 
For enrolled patients coming from an inpatient ICU, as part of usual care, a standard 12-
lead ECG will be performed prior to performance of the PUG procedure. Interpretation of 
the tracing will be made by a member of the study team who is a qualified physician 
skilled in ECG interpretation. The interpretation of the 12-lead ECG will be documented 
by the study team member in the CRF. A copy of the ECG tracing should be labeled with 
the study and patient number, date, and kept in the source documents at the study site. 
Clinically significant abnormalities should also be recorded on the CRF as appropriate. 
In the event that there are significant abnormalities present on the ECG and the study 

 
 
 
 
 
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team member performing the interpretation is not the same as the proceduralist then the 
study team member will notify the proceduralist prior to commencing the study 
procedure. 
 
Pregnancy Testing 
Female patients must have a negative urine or serum pregnancy test in order to be 
enrolled in the study. Those females who have had a total hysterectomy or bilateral 
oophorectomy, or who are 2 years post-menopausal do not require a pregnancy test. 
Results of any pregnancy testing will be noted in the CRF. 
 
 
 

 
 
 
 
 
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Concomitant Medications, Therapies, and Interventions 
All therapies/interventions administered to and medical/surgical procedures performed 
on the study patients from the time of informed consent through the follow-up contact will 
be documented on the CRF. 
 
All prescription and over-the-counter medications being taken by patients during the 
study are regarded as concomitant medications and must be documented on the CRF 
following informed consent. For any medication that is administered, the investigator will 
document the drug name, amount, route of administration, frequency, and duration 
administered, as well as the reason for administering the medication.  
 
Medical/surgical procedures performed during the study will also be recorded on the 
CRF, along with the date and time, and reason for the intervention. This includes airway 
interventions (intubation, tracheotomy, and cricothyrotomy).  
 
Adverse Event Assessments 
 
Adverse Event (AE) 
 
An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or 
metabolic function as indicated by physical signs, symptoms, or laboratory changes 
occurring in any phase of a clinical study, whether or not considered related to the study 
procedure. This includes an exacerbation of a pre-existing condition.  
 
Adverse events include the following:  
. 
Worsening (change in nature, severity, or frequency) of conditions present at the 
onset of the study   
. 
Intercurrent illnesses   
. 
Drug interactions   
. 
Events related to or possibly related to concomitant medications   
. 
Abnormal laboratory values that the investigator considers clinically significant 
(includes  significant shifts from baseline within the range of normal that the 
investigator considers  to be clinically important)   
. 
Abnormalities in physical examination   
 
Throughout the study, the investigator must record all AEs on the AE CRF, regardless of 
the severity or relationship to study procedure. The investigator should treat patients with 
AEs appropriately and observe them at suitable intervals until the events stabilize or 
resolve. Adverse events may be discovered through observation or examination of the 
patient, questioning of the patient, complaint by the patient, or by abnormal clinical 

 
 
 
 
 
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laboratory values.  In addition, AEs should also include those laboratory values that 
become out-of-range and are judged to be clinically significant.   
 
Serious Adverse Event (SAE) 
 
A Serious Adverse Event is any experience that suggests a significant hazard, 
contraindication, side effect or precaution. It is any AE that at any dose fulfills at least 
one of the following criteria:  
• 
is fatal; [results in death**; NOTE: death is an outcome, not an event]   
• 
is Life-Threatening [NOTE: the term "Life-Threatening" refers to an event in 
which the patient was at immediate risk of death at the time of the event; it does 
not refer to an event which could hypothetically have caused a death had it been 
more severe]   
• 
requires in-patient hospitalization or prolongation of existing hospitalization  
• 
results in persistent or significant disability/incapacity   
• 
is a congenital anomaly/birth defect   
• 
is medically significant or requires intervention to prevent one or other of the 
outcomes listed above.   
 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical 
judgment, that may jeopardize the patient and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. A life-threatening AE 
is defined as an AE that placed the patient, in the view of the initial reporter, at 
immediate risk of death from the AE as it occurred (ie, it does not include an AE that, 
had it occurred in a more severe form, might have caused death).   
 
Table 3. Adverse Events Scoring System 
Pt 
Identifie
r 
AE Onset 
AE 
End 
AE Code 
(MedRA, 
CTCAE) 
Severity 
SAE
? 
(Y/N) 
Related
-ness 
Action 
Taken 
Outcome 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Severity of AE: 
Relatedness to Intervention: 
1 = Mild 
0 = Definitely unrelated 
2 = Moderate 
1 = Unlikely 
3 = Severe 
2 = Possibly related 
4 = Life threatening or disabling 
3 = Probably related 
4 = Definitely related 
 

 
 
 
 
 
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Action Taken: 
0 = None 
Outcome: 
1 = Dose modification 
1 = Resolved 
2 = Medical intervention  
2 = Recovered with minor sequelae 
(specify in comments) 
3 = Recovered with major sequelae 
3 = Hospitalization 
4 = Continuing treatment 
4 = Intervention discontinued 
5 = Condition worsening 
5 = Other 
6 = Patient death** 
 
 
Pregnancy Reporting 
 
Pregnancy is an exclusion to enrollment in the current study. If it is determined after 
enrollment that the study subject is pregnant then all study procedures will be terminated 
and the Research Ethics Board (REB) will be notified of the protocol deviation. The 
subject should be followed through the pregnancy for assessment of possible 
relationship of harm to the study treatment.  
 
Any SAE experienced during pregnancy must be reported to the REB. 
 
Ethical Considerations 
 
This clinical study was designed and shall be implemented and reported in accordance 
with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable 
local regulations and with the ethical principles laid down in the Declaration of Helsinki. 
 
Research Ethics Board 
 
Before implementing this study, the protocol and the informed consent form must be 
reviewed by a properly constituted REB. A signed and dated statement that the protocol 
and informed consent have been approved by the REB must be on file at the site before 
study initiation. Any amendments to the protocol, other than administrative ones, must 
be approved by the REB.  
If an inspection of the clinical site is requested by a regulatory authority, the investigator 
must inform CoapTech immediately that this request has been made.  
 
Informed Consent 
 
The Investigator must explain to each participant (or legally authorized representative, 
LAR) the nature of the study, the purpose, the procedures involved, the expected 
duration, the potential benefits and risks involved, and any discomfort it may entail. The 
study procedure should be identified as investigational (experimental) and that its rate of 
adverse events are not completely known. This information must be provided in 

 
 
 
 
 
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language that the participant understands. Each participant must be informed that 
participation in the study is voluntary and that they may withdraw from the study at any 
time, and that withdrawal of consent will not affect their subsequent medical treatment or 
relationship with the treating physician. The participant or LAR should read and consider 
the statement before signing and dating it and should be given a copy of the signed 
document. No participant can enter the study before Informed consent has been 
obtained.  
 
The study seeks a waiver of consent for recruitment of patients to the comparison 
matched historical cohort of patients who received the standard of care, PRG, 
procedure. The involvement in this arm of the research study presents no more than 
minimal risk of harm to participants and involves no procedures for which written consent 
is normally required outside of the research context. The same data will be collected in a 
retrospective fashion using electronic medical record and medical center data sources. 
Per the study protocol outlined elsewhere, no identifiable patient information will be 
collected to ensure confidentiality. 
 
Protocol Adherence 
 
Investigators ascertain they will apply due diligence to avoid protocol deviations.  
This protocol defines the study objectives, the study procedures and the data to be 
collected on study participants. Under no circumstances should an investigator collect 
additional data or conduct any additional procedures for any research related purpose 
involving any investigational drugs or devices.  
 
Protocol Amendments 
 
Alterations to the protocol can only be made in a written protocol amendment that must 
be approved by the PI, CoapTech, and the REB. Only amendments that are required for 
imminent threat to patient safety may be implemented prior to REB approval. 
Notwithstanding the need for approval of formal protocol amendments, the investigator is 
expected to take any immediate action required for the safety of any patient included in 
this study, even if this action represents a deviation from the protocol. In such cases, 
CoapTech should be notified of this action and the REB at the study site should be 
informed within 10 working days or less, if required by local regulations.  
 
Data Handling and Record Keeping 
 
Source data/documentation is defined as the first place that data is recorded. Any and all 
source documents must be maintained and be retrievable at the site. The Investigator 
must maintain source documents for each participant in the study.  
 

 
 
 
 
 
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All data collected during the course of the study will be obtained from primary sources 
that have been recorded in written and electronic documents such as the participant’s 
medical file. The results of physical exams, vital signs, laboratory findings, and ECG 
tracings will be recorded in the participant’s medical and/or research files. Data collected 
on digital CRFs during the trial will be documented in an anonymous fashion, and study 
subjects will only be identified by subject numbers in places other than the initial 
demographic form. Study site will utilize digital CRFs stored on the secure and cloud 
based platform RedCap.  
 
The source documents should contain all demographic and medical information 
including laboratory data, ECGs, etc., and the signed informed consent form, which 
should indicate the study number and title of the trial.  
 
The Investigator(s) agree(s) to adhere to the document retention procedures by a signed 
contract. Essential documents include, but are not limited to REB-approved study 
protocol and subsequent amendments (if applicable), information given to study 
participants (REB approved informed consent form template, recruitment materials and 
any other written communications), CRFs, curriculum vitae for any person authorized by 
the Investigator to assist with trial activities, delegation of authority/site signature log, 
monitoring visit logs, laboratory reports (or equivalent), laboratory reference ranges, 
laboratory certifications, and any other pertinent documents.  
 
Administrative Considerations 
 
Investigators and Study Administrative Structure 
The investigator should ensure that all persons assisting with the study are adequately 
informed about the protocol, any amendments to the protocol, the study treatments, and 
their study related duties and functions. The investigator must maintain a list of sub-
investigators and other appropriately qualified persons to whom he or she has delegated 
significant study related duties. 
 
Research Ethics Board Approval  
Before initiation of the study, the investigator must provide the sponsor with a copy of the 
written REB approval of the protocol and the informed consent form. This approval must 
refer to the informed consent form and to the study title, study number, and version and 
date of issue of the study protocol, as given by the sponsor on the cover page of the 
protocol.  
 
Status reports must be submitted to the REB at least once per year. The REB must be 
notified of completion of the study; a final status report must be provided to the REB 
within 3 months of study completion or termination (or as required). A copy of these 
reports will be sent to the study clinical monitor. The investigator must maintain an 

 
 
 
 
 
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accurate and complete record of all submissions made to the REB, including a list of all 
reports and documents submitted.  
 
Ethical Conduct of the Study 
The procedures set out in this study protocol, pertaining to the conduct, evaluation, and 
documentation of this study, are designed to ensure that the sponsor and investigator 
abide by Good Clinical Practice (GCP) as described in the 21 CFR Parts 50, 56, and 312 
and the International Conference on Harmonisation (ICH) GCP Guidelines Compliance 
with these regulations and guidelines also constitutes compliance with the ethical 
principles described in the Declaration of Helsinki.  
 
Patient Information and Consent: Prospective Clinical Study 
 
Before enrolling in the prospective clinical study, the patient or legally authorized 
representative(s) must consent to participate after the nature, scope, and possible 
consequences of the clinical study have been explained in a form understandable to him 
or her.  
 
An informed consent form (assent form if applicable) that includes information about the 
study will be prepared and given to the patient or the patient’s legally authorized 
representative(s). This document will contain all FDA and ICH-required elements. The 
informed consent form must be in a language understandable to the patient or the 
patient’s legally authorized representative(s) and must specify who informed the patient 
or the patient’s legally authorized representative(s).  
 
After reading the informed consent document, the patient or the patient’s legally 
authorized representative(s) must give consent in writing. Consent must be confirmed at 
the time of consent by the personally dated signature of the patient, the patient’s legally 
authorized representative(s) and by the personally dated signature of the person 
conducting the informed consent discussions.  
 
If the patient or the patient’s legally authorized representative(s) is unable to read, oral 
presentation and explanation of the written informed consent form and information to be 
supplied must take place in the presence of an impartial witness. Consent must be 
confirmed at the time of consent orally and by the personally dated signature of the 
patient or by a local legally recognized alternative (eg, the patient’s thumbprint or mark) 
or by the personally dated signature of the patient’s legally authorized representative. 
The witness and the person conducting the informed consent discussions must also sign 
and personally date the informed consent document. It should also be recorded and 
dated in the source document that consent was given.  
 

 
 
 
 
 
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A copy of the signed and dated consent document(s) must be given to the patient or the 
patient’s legal representative(s). The original signed and dated consent document will be 
retained by the investigator.  
 
The investigator will not undertake any measures specifically required solely for the 
clinical study until valid consent has been obtained.  
 
Patient Information and Consent: Retrospective Matched Cohort 
 
The study seeks a waiver of consent for recruitment of patients to the comparison 
matched historical cohort of patients who received the standard of care, PRG, 
procedure. The involvement in this arm of the research study presents no more than 
minimal risk of harm to participants and involves no procedures for which written consent 
is normally required outside of the research context. The same data will be collected in a 
retrospective fashion using electronic medical record and medical center data sources. 
Per the study protocol outlined elsewhere, no identifiable patient information will be 
collected to ensure confidentiality. 
 
 
 
Patient Confidentiality 
Patient names will not be supplied to the sponsor. Only the patient number and patient 
initials will be recorded in the CRF, and if the patient name appears on any other 
document, it must be obliterated before a copy of the document is supplied to the 
sponsor. Study findings stored on a computer will be stored in accordance with local 
data protection laws. The patients will be told that representatives of the sponsor, a 
designated contract research organization, the REB, or regulatory authorities may 
inspect their medical records to verify the information collected, and that all personal 
information made available for inspection will be handled in strictest confidence and in 
accordance with local data protection laws. The investigator will maintain a personal 
patient identification list (patient numbers with the corresponding patient names) to 
enable records to be identified.  
 
Case Report Forms and Study Records 
Case report forms (digital/electronic) are provided for each patient. All forms must be 
filled out by authorized study personnel. All corrections to the original CRF entry must 
indicate the reason for change. The investigator is required to sign the CRF after all data 
have been captured for each patient. If corrections are made after review and signature 
by the investigator, he or she must be made aware of the changes, and his or her 
awareness documented by re-signing the CRF.  
 
Data Monitoring Committee 

 
 
 
 
 
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An independent DSMB will be established to provide an independent review and 
assessment of the safety data, and to safeguard the interests and safety of the 
participating patients in the study. The DSMB will consist of, at the minimum, a physician 
knowledgeable in gastrostomy tube placement with additional expertise in clinical 
research methodology and safety.  
 
The DSMB will adhere to a prospectively determined Charter, which will be written by 
the principal investigator and approved by the study sponsor and the DSMB. The 
Charter will define the responsibilities of the DSMB, the number and timing of the DSMB 
meetings, the conduct of the meetings, and the data sets to be reviewed by the DSMB.  
 
At a minimum, the DSMB will review the study data when 50% enrollment has been 
achieved. All AEs and SAEs will be made available to the DSMB. The DSMB may also 
be asked to review on an ongoing basis other SAEs of concern.  
 
The DSMB will provide the principal investigator and the study sponsor with summary 
reports after each meeting.  
 
Protocol Violations/Deviations 
The investigator will conduct the study in compliance with the protocol. The protocol will 
not be initiated until the REB and the appropriate regulatory authorities have given 
approval/favorable opinion. Modifications to the protocol will not be made without 
agreement of the sponsor. Changes to the protocol will require written REB 
approval/favorable opinion prior to implementation, except when the modification is 
needed to eliminate an immediate hazard(s) to patients. The REB may provide, if 
applicable regulatory authorities permit, expedited review and approval/favorable opinion 
for minor change(s) in ongoing studies that have the approval/favorable opinion of the 
REB. The sponsor will submit all protocol modifications to the regulatory authorities in 
accordance with the governing regulations.  
 
No protocol exemption will be granted for this study.  
 
When immediate deviation from the protocol is required to eliminate an immediate 
hazard(s) to patients, the investigator will contact the sponsor or its designee, if 
circumstances permit, to discuss the planned course of action. Any departures from the 
protocol must be fully documented as a protocol deviation. Protocol deviations will need 
to be reviewed by the sponsor and may also be required to be submitted to the REB. 
 
Premature Closure of the Study 
If the sponsor, investigator, DSMB, or regulatory authorities discover conditions arising 
during the study, which indicate that the clinical investigation should be halted due to an 
unacceptable patient risk, the study may be terminated after appropriate consultation 

 
 
 
 
 
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between the sponsor and the investigator(s). In addition, a decision on the part of the 
sponsor to suspend or discontinue development of the investigational product may be 
made at any time.  
 
Access to Source Documentation 
Regulatory authorities, the REB, or the sponsor may request access to all source 
documents, CRFs, and other study documentation for onsite audit or inspection. Direct 
access to these documents must be guaranteed by the investigator, who must provide 
support at all times for these activities. Monitoring and auditing procedures that comply 
with current GCP guidelines will be followed. On-site review of the CRFs for 
completeness and clarity, crosschecking with source documents, and clarification of 
administrative matters may be performed. 
 
Data Generation and Analysis 
The clinical database will be developed and maintained by the principal investigator. The 
principal investigator will be responsible for performing study data management 
activities. 
 
Retention of Data 
Essential documents should be retained until at least 2 years after the last approval of a 
marketing application and until there are no pending or contemplated marketing 
applications or at least 2 years have elapsed since the formal discontinuation of clinical 
development of the product. The sponsor will notify the investigator if these documents 
must be retained for a longer period of time. It is the responsibility of the sponsor to 
inform the investigator or institution as to when these documents no longer need to be 
retained.  
 
 
 

 
 
 
 
 
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Financial Disclosure 
The investigator should disclose any financial interests in the sponsor as described in 21 
CFR Part 54 prior to beginning this study. The appropriate form will be provided to the 
investigator by the sponsor, which will be signed and dated by the investigator, prior to 
the start of the study. Changes in status concerning financial interests during the study 
and after its completion will be disclosed by the Investigator in accordance 21 CFR Part 
54.  
 
Publication and Disclosure Policy 
All information concerning the study material, such as patent applications, manufacturing 
processes, basic scientific data, and formulation information supplied by the sponsor and 
not previously published are considered confidential and will remain the sole property of 
the sponsor. The investigator agrees to use this information only in accomplishing this 
study and will not use it for other purposes.  
 
It is understood by the investigator that the information developed in the clinical study 
may be disclosed as required to the authorized regulatory authorities and governmental 
agencies. In order to allow for the use of the information derived from the clinical studies, 
it is understood that there is an obligation to provide the sponsor with complete test 
results and all data developed in the study in a timely manner.  
 
The investigator and any other clinical personnel associated with this study will not 
publish the results of the study, in whole or in part, at any time, unless they have 
consulted with the sponsor, provided the sponsor a copy of the draft document intended 
for publication, and obtained the written consent of the sponsor for such publication. All 
information obtained during the conduct of this study will be regarded as confidential. 
 
 
 
 

 
 
 
 
 
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References 
 
Roche V. Percutaneous endoscopic gastrostomy. Clinical care of PEG tubes in older 
adults. Geriatrics. 2003;58(11):22–6–28–9. 
 
Goldberg E, Kaye R, Yaworski J, Liacouras C. Gastrostomy tubes: facts, fallacies, 
fistulas, and false tracts. Gastroenterol Nurs. 2005;28(6):485–93–quiz493–4. 
 
Lynch CR, Fang JC. Prevention and Management of Complications of Percutaneous 
Endoscopic Gastrostomy (PEG) Tubes. Pract Gastroenterol. 2004;28(11):66-76. 
 
Bravo JG, Bravo JGP, Ide E, et al. Percutaneous endoscopic versus surgical 
gastrostomy in patients with benign and malignant diseases: a systematic review and 
meta-analysis. Clinics (Sao Paulo). 2016;71(3):169-178.  
 
Yuan Y, Zhao Y, Xie T, Hu Y. Percutaneous endoscopic gastrostomy versus 
percutaneous radiological gastrostomy for swallowing disturbances. Cochrane Database 
Syst Rev. 2016;2:CD009198. 
 
Gauderer MW, Ponsky JL, Izant RJ. Gastrostomy without laparotomy: a percutaneous 
endoscopic technique. J Pediatr Surg. 1980;15(6):872-875. 
 
Itkin M, Itkin M, DeLegge MH, et al. Multidisciplinary practical guidelines for 
gastrointestinal access for enteral nutrition and decompression from the Society of 
Interventional Radiology and American Gastroenterological Association (AGA) Institute, 
with endorsement by Canadian Interventional Radiological Association (CIRA) and 
Cardiovascular and Interventional Radiological Society of Europe (CIRSE). 
Gastroenterology. 2011;141(2):742-765. 
 
 
 

 
 
 
 
 
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Version History 
 
Version 
Date 
Description 
1.0 
21 Jun 2018 
Initial Release 
1.1 
10 Aug 2018 
Added Version and Date of Last Modification 
1.2 
04 Sept 2018 
Added Clarification Text re: REB Recommendation