Feasibility Study of the Kronos Electrocautery Device
Phase: NA
Conditions: Hepatic Disease, Renal Disease
Sponsor: Single Pass Inc

 
 
 
 
Protocol for the  
Feasibility Study of the  
Kronos Electrocautery Device  
 
 
 
NCT # 05593211 
 
 
November 7th, 2022 

Single Pass, Inc 
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CONFIDENTIAL 
 
 
 
 
Feasibility Study of the  
Kronos Electrocautery Device  
 
 
 
 
 
 
 
  
 
 
 Funding Sponsor: 
         
Single Pass, Inc. 
105 N. Pointe Drive, Ste B 
Lake Forest, CA 92630 
+1 602-618-3377 
   
   Study Product: 
 
Kronos Electrocautery Device 
 
Short Name: 
 
Protocol Number: 
 
Version: 
 
 
Date: 
 
Kronos Study 
 
SP-01 
 
Version 2.0 
 
 
October 4th, 2022 
 
 
 
 
 
 
 
 
 

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Table of Contents 
  
TABLE OF CONTENTS .................................................................................................................................................................. 2 
1 
PROTOCOL APPROVAL FORM ................................................................................................................................. 4 
2 
LIST OF ABBREVIATIONS ......................................................................................................................................... 5 
3 
STUDY SUMMARY ................................................................................................................................................... 6 
4 
INTRODUCTION ...................................................................................................................................................... 8 
4.1 
PURPOSE .................................................................................................................................................................... 8 
4.2 
BACKGROUND ............................................................................................................................................................. 8 
5 
RISK BENEFIT ANALYSIS ........................................................................................................................................... 8 
5.1 
RISKS TO THE PATIENT -FMEA ....................................................................................................................................... 8 
5.2 
POTENTIAL BENEFITS TO THE PATIENT .............................................................................................................................. 9 
6 
STUDY OBJECTIVES ................................................................................................................................................. 9 
7 
STUDY DESIGN ...................................................................................................................................................... 10 
7.1 
GENERAL DESCRIPTION ................................................................................................................................................ 10 
7.2 
NUMBER OF SUBJECTS ................................................................................................................................................ 10 
UP TO 30 SUBJECTS ................................................................................................................................................................. 10 
7.3 
DURATION OF PARTICIPATION ....................................................................................................................................... 10 
7.4   PRIMARY STUDY OUTCOMES .............................................................................................................................................. 10 
7.4 
SECONDARY STUDY OUTCOMES .................................................................................................................................... 10 
ABSENCE OF SECONDARY REINTERVENTION ................................................................................................................................... 10 
TIME TO HOSPITAL DISCHARGE ................................................................................................................................................... 10 
7.6    IDENTIFICATION OF SOURCE DATA ...................................................................................................................................... 10 
8 
SUBJECT SELECTION ENROLLMENT AND WITHDRAWAL ........................................................................................ 10 
8.1 
INCLUSION CRITERIA ................................................................................................................................................... 10 
8.2 
EXCLUSION CRITERIA ................................................................................................................................................... 11 
8.3 
SUBJECT RECRUITMENT, ENROLLMENT AND SCREENING ..................................................................................................... 11 
8.4.  EARLY WITHDRAWAL OF SUBJECTS ...................................................................................................................................... 11 
8.4.1 WHEN AND HOW TO WITHDRAW SUBJECTS ........................................................................................................................ 11 
8.4.2 DATA COLLECTION AND FOLLOW-UP FOR WITHDRAWN SUBJECTS ............................................................................................ 12 
9 
STUDY DEVICE ...................................................................................................................................................... 12 
9.1 
DESCRIPTION ............................................................................................................................................................. 12 
10 
STUDY PROCEDURES ......................................................................................................................................... 13 
10.1 
VISIT 1 (SCREENING AND ENROLLMENT UP TO THE DAY OF BIOPSY) ...................................................................................... 13 
10.2 
VISIT 2 (TREATMENT – DAY OF BIOPSY PROCEDURE) ......................................................................................................... 13 
10.3 
SCHEDULE OF EVENTS ................................................................................................................................................. 14 
11 
STATISTICAL PLAN ............................................................................................................................................ 14 
11.1 
SAMPLE SIZE ............................................................................................................................................................. 14 
11.2 
HANDLING OF MISSING DATA ....................................................................................................................................... 14 

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12. 
SAFETY AND ADVERSE EVENTS ......................................................................................................................... 14 
12.1 
DEFINITIONS .............................................................................................................................................................. 14 
12.2 
RECORDING OF ADVERSE EVENTS .................................................................................................................................. 16 
12.3 
REPORTING OF SERIOUS ADVERSE EVENTS AND UNANTICIPATED PROBLEMS .......................................................................... 17 
12.3.1 
PRINCIPAL INVESTIGATOR REPORTING NOTIFYING THE IRB .............................................................................................. 17 
12.4 MEDICAL MONITORING .................................................................................................................................................... 18 
13 
DATA HANDLING AND RECORD KEEPING .......................................................................................................... 19 
13.1 
CONFIDENTIALITY ....................................................................................................................................................... 19 
13.2 
SOURCE DOCUMENTS ................................................................................................................................................. 19 
13.3 
CASE REPORT FORMS .................................................................................................................................................. 19 
13.4 
DATA MANAGEMENT .................................................................................................................................................. 19 
13.5 
DATA PROCESSING ..................................................................................................................................................... 19 
13.6 
DATA SECURITY AND CONFIDENTIALITY ........................................................................................................................... 20 
13.7 
DATA QUALITY ASSURANCE .......................................................................................................................................... 20 
13.8 
DATA CLARIFICATION PROCESS ..................................................................................................................................... 20 
13.9 
RECORDS RETENTION .................................................................................................................................................. 20 
14 
STUDY MONITORING, AUDITING, AND INSPECTING .......................................................................................... 20 
14.1 
STUDY MONITORING PLAN .......................................................................................................................................... 20 
14.2 
AUDITING AND INSPECTING .......................................................................................................................................... 20 
15 
ETHICAL CONSIDERATIONS ............................................................................................................................... 21 
16 
STUDY FINANCES .............................................................................................................................................. 21 
16.1 
FUNDING SOURCE ...................................................................................................................................................... 21 
16.2 
CONFLICT OF INTEREST ................................................................................................................................................ 21 
16.3 
SUBJECT STIPENDS OR PAYMENTS .................................................................................................................................. 21 
17 
PUBLICATION PLAN .......................................................................................................................................... 22 
18 
REFERENCES ..................................................................................................................................................... 22 
19 
ATTACHMENTS ................................................................................................................................................. 23 
1. 
ATTACHMENT A: KRONOS SCORING CRITERIA ...................................................................................................... 23 
ATTACHMENT A: KRONOS SCORING CRITERIA ............................................................................................................... 23 
 

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1 Protocol Approval Form 
Protocol Name: Kronos Study 
 
I agree to conduct the study as detailed in this Clinical Investigational Plan and in accordance 
with all applicable regional laws and regulations. In addition, I agree to provide all the 
information requested in the case report forms presented to me by the sponsor in a manner to 
assure completeness, legibility and accuracy. 
  
I agree to actively enroll patients into this study and confirm that I do not have any material 
conflicts including participation in any clinical investigations for similar types of medical 
devices. I will provide copies of this registry protocol and all necessary information about this 
registry to the registry staff under my supervision. I will discuss this material with them and 
ensure they are fully informed about the device under investigation as well as all aspects 
concerning the conduct of this registry.  
 
I also agree that all information provided to me by the sponsor, including pre-clinical data, 
protocols, case report forms, and any verbal and written information, will be kept strictly 
confidential and confined to the clinical personnel involved in conducting the registry. It is 
recognized that this information may be relayed in confidence to the Ethics Committee or 
Institutional Review Board or to regulatory authorities. 
 
In addition, no reports or information about the study or its progress will be provided to anyone 
not involved in the registry other than the sponsor, the Ethics Committee(s) or Institutional 
Review Board(s), the core labs, or the independent medical reviewer. Any such submission 
will indicate that the material is confidential.  
 
I will supervise the conduct of the clinical investigation to be performed in compliance with 
the clinical investigational plan, Good Clinical Practice (GCP)/ICH, the Declaration of 
Helsinki, and all applicable regulatory and ethical requirements. 
_______________________________________________________________________________ 
Investigator Site Name 
_______________________________________________________________________________ 
Site Principal Investigator (Signature) 
Date 
________________________________________ 
Site Principal Investigator (Printed Name) 
_______________________________________________________________________________ 
Sponsor (Signature) 
Date 
________________________________________ 
Sponsor (Printed Name) 
 
 

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2 List of Abbreviations  
 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
DSMB 
Data and Safety Monitoring Board 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HER 
Electronic Health Record 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
IRB 
Institutional Review Board 
Non-UPIRTSO 
Non-Unanticipated Problems Involving Risk to Subjects or Others 
PHI 
Protected Health Information 
PI 
Principal Investigator 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOP 
Standard Operating Procedure 
UPIRTSO 
Unanticipated Problems Involving Risk to Subjects or Others 

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3 Study Summary 
 
Title 
 
Feasibility Study of the Kronos Electrocautery Device 
 
Protocol Name 
Kronos Study 
Protocol Number 
SP-01, Version 1.0 
Phase 
N/A 
Methodology 
Pilot Study, Non-Randomized 
Overall Study 
Duration 
(Estimated) 
4 months 
Subject Participation 
Duration 
(Estimated) 
14 Days post procedure  
Number of Sites 
Up to 5 
Objectives 
The primary objective for this study is to assess safety and performance 
of the Kronos Electrocautery Device for electrocautery procedures 
following coaxial biopsy procedures on areas that include, but are not 
limited to, liver, kidney, lungs, breasts, soft tissue, etc.    
Intended Purpose 
The Kronos Electrocautery Device is intended to be used in 
electrocautery procedures to control bleeding by use of electrical current 
to heat the device probe tip that is applied directly to the target tissue area 
of treatment. 
 
Study Design 
Prospective, multicenter, single arm study with consecutive, eligible 
subject enrollment at each site. Patients who require a coaxial biopsy 
procedures on areas that include, but are not limited to, liver, kidney, 
lungs, breasts, soft tissue, etc., will be eligible to participate in this study.  
Number of Subjects 
Up to 30 patients 
Primary Endpoint 
Assess rate of successful electrocautery procedure in absence of procedure 
related Adverse Events 
Inclusion Criteria 
1. Patients undergoing a scheduled elective  coaxial biopsy procedures 
on areas that include, but are not limited to, liver, kidney, lungs, 
breasts, soft tissue, etc.,  
2. Patients have signed an informed consent  
3. Patients who are ≥ 18 years of age. 
 

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 Exclusion Criteria 
 
1. Patients with known bleeding disorder 
2. Significant congenital anomaly or medical problem that in the opinion 
of the investigator would preclude enrollment in this study. 
3. Women of childbearing potential who are pregnant, lactating, or 
planning to become pregnant during the course of the clinical 
investigation. 
4. Active systemic infection or sepsis. 
Study Device 
Kronos Electrocautery Device 
Duration of Use 
The Kronos Electrocautery Device is a single use probe that will be used 
during procedure only. 
Statistical 
Methodology 
No formal hypothesis is proposed in this protocol. All outcomes and analyses 
will be presented in descriptive manner only. 
Applicable 
standards 
The study will be conducted in compliance with this protocol and the 
following applicable regulations & Good Clinical Practices (GCPs): 
 
ISO 15444: 2020 
 
 
 
 
 
 

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4 Introduction 
 
This document is a protocol for a human research study. This study will be carried out in 
accordance with the applicable United States government regulations, EU Regulation 2017/745 
Chapter VI and Annex XV and enrolling research centers policies and procedures. 
 
4.1 
Purpose 
       
 The purpose of this feasibility study is to evaluate the safety and performance of the Kronos 
Electrocautery Device to verify the in-animal models evaluated optimal withdrawal parameters 
in humans to reduce or prevent bleeding following a coaxial biopsy procedures on areas that 
include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc. 
 
 
4.2 
Background 
Ultrasound-guided percutaneous liver and kidney biopsies are used widely for the diagnosis, 
staging and follow-up of hepatic and renal disease. Complications of these procedures include 
pain, bleeding, pneumothorax, bile peritonitis, arteriovenous fistula formation, glomeruli in 
kidney biopsies, hemorrhage, and others. Of the serious complications, bleeding is the most 
common, with an incidence ranging from 0.8 percent (%) to 1%, and subsequent fatality may 
occur in as many as three (3) out of 10,000 liver biopsies. Similarly, the bleeding complications 
from kidney biopsies have been reported as between 9% to 34%.1,2,3 In addition, bleeding from 
breast  biopsies have occurred in incidences ranging from 6.6% to 8.2%, and occurrences of 
bleeding from lung biopsies range from .6% - 17.6%.5 
 
5 Risk Benefit Analysis 
 
5.1 
Risks to the Patient -FMEA 
 
No additional risks are associated with the use of Kronos Electrocautery Device compared to 
existing electrocautery devices. 
 
POTENTIAL ADVERSE EVENTS  
Possible complications associated with the use of the Kronos device are similar to those 
associated with electrocautery devices and include, but may not be limited to:  
 
Common (occurs in more than 10% of patients undergoing this type of procedure): 
• Pain – study device or standard of care biopsy related 
• Hemorrhage/Bleeding – study device or standard of care biopsy related 
• Internal and external burn – study device related 
• Scarring – study device or standard of care biopsy related 

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Less Common (occurs in 1-10% of patients undergoing this procedure): 
• Reintervention - – study device or standard of care biopsy related 
 
Rare (occurs in less than 1% of patients undergoing this type of procedure): 
• Allergic Reaction – study device or standard of care biopsy related 
• Inflammatory Response - – study device or standard of care biopsy related 
• Infection - study device or standard of care biopsy related 
• Death - study device or standard of care biopsy related 
• Interference with implantable device – study device related 
 
 
5.2 
Potential Benefits to the Patient 
Reduction or prevention of bleeding following a biopsy procedure could prevent the need of 
hospitalization, blood transfusion and sometimes surgery or another procedure to stop the 
bleeding. 
 
6 Study Objectives 
 
To objective of this study is to verify the in-animal models evaluated optimal withdrawal 
parameters in humans to reduce and control bleeding following a biopsy procedure and to 
assess preliminary usability evaluations of the Kronos Electrocautery Device. 
 
 
 
 
 

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7 Study Design 
 
7.1 
General Description 
 
This is a multi-center, prospective, non-randomized feasibility study designed to evaluate the 
performance of the Kronos Electrocautery Device to verify the in-animal models evaluated optimal 
withdrawal parameters in humans to reduce or prevent bleeding following a biopsy procedure and to 
assess preliminary usability evaluations. 
 
7.2 Number of Subjects    
 
Up to 30 subjects 
 
7.3    Duration of Participation 
 
                 Up to 14 days    
 
 7.4   Primary Study Outcomes            
 
              Absence of Hematoma formation 
 
Measure and categorize amount of blood loss from biopsy access site 
 
Absence of the need for ultrasound examination due to observation of bleeding 
           
7.4 
Secondary Study Outcomes 
 
Absence of secondary reintervention 
Time to hospital discharge 
   
7.6    Identification of Source Data 
 
         The study data will be captured and recorded on paper source documents.  
.  
8 Subject Selection Enrollment and Withdrawal 
 
8.1 
Inclusion Criteria 
1. Patients undergoing a scheduled elective coaxial biopsy procedures on areas that include, 
but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc., 
2. Patients have signed an informed consent  
3. Patients who are ≥ 18 years of age. 
 
 

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8.2 Exclusion Criteria 
 
1. Patients with known bleeding disorder 
2. Significant congenital anomaly or medical problem that in the opinion of the investigator 
would preclude enrollment in this study. 
3. Women of child baring potential who are pregnant, lactating, or planning to become 
pregnant during the course of the clinical investigation. 
4.  Active systemic infection or sepsis. 
 
8.3 Subject Recruitment, Enrollment and Screening 
 
Subjects will be enrolled from the research centers. The study has an accrual target of at least 20 
patients. The initial accrual period will last up to three months. Patients will be provided with an 
IRB approved Research Participant Informed Consent Form and Privacy Authorization Form 
describing the study devices, protocol, inclusion and exclusion criteria, as well as risks and 
benefits of participation. 
 
8.4.  Early Withdrawal of Subjects 
 
Patients are free to withdraw at any time and for whatever reason. If patient withdraws consent 
prior to the biopsy procedure, the study data will not be collected. If patient withdraws consent 
after study data was already completed, the participant will need to provide instructions to the 
study team to remove his/her data from the data set. Pre-specified reasons for discontinuing 
include, but are not limited to, the following: 
 
1. Patient Request: Patient decided that he/she did not want to continue (for any reason) 
2. Adverse Event: Patient experienced a related or unrelated event that would interfere with 
the study objectives/evaluation 
3. Inclusion/Exclusion Discrepancy/Violation: Patient should not have been enrolled 
4. Other: Any other reason 
  
 
8.4.1 When and How to Withdraw Subjects 
 
The patient’s participation in this clinical research study is voluntary. If patient decides to take 
part in this study, he/she will be asked to sign the Informed Consent Form showing that he/she 
has been informed about the clinical research study. A signed original of the Informed Consent 
Form will be provided to the patient and a signed second original will be retained in the 
patient’s medical record. 
 
The patient may decide to stop participating in this study at any time. If the patient decides to 
withdraw from this study, the patient will be asked to participate in a limited capacity allowing 
the patient’s medical status to be followed by telephone contact, medical chart review, or by 

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other agreed upon method.  
 
If the patient decides not to continue participation in a limited capacity, the doctor will not 
access patient’s medical record or other confidential records for new purposes related to the 
study; however, study data collected prior to the patient’s withdrawal may be reviewed and 
publicly available records may be consulted prior to or after your withdrawal. If the patient 
decides to stop taking part in this clinical research study, the patient shall tell his/her study 
doctor as soon as the patient decides to stop.  
 
The patient’s decision to not participate or withdraw or discontinue participation will not result 
in any penalty or loss of medical care or benefits to which the patient might be otherwise 
entitled. 
 
The patient’s study doctor may end the patient’s participation in this clinical research study 
without the patient’s consent. Some of the reasons for ending your participation may be: 
 
The study doctor thinks it is necessary for the patient’s health and safety; 
1. If the patient becomes pregnant; 
2. If the patient does not receive a device; 
3. If the patient is unable to keep the his/her scheduled appointments; 
4. If the study is stopped by the Sponsor, the Institutional Review Board or by a 
regulatory authority, such as the FDA. 
5. If the patient does not consent to continue in the study after being told of changes in 
the clinical research study that may affect the patient, or 
6. For administrative reasons 
 
8.4.2 Data Collection and Follow-up for Withdrawn Subjects 
 
          If a participant withdraws from the study, no additional attempts will be made to contact the    
participant. 
 
 
9 Study Device 
 
9.1 
Description 
 
The Kronos Electrocautery Device (Figure 1) is a disposable electrocautery device that can 
cauterize deep tissue through a standard biopsy procedure guide needle. This device is intended 
to coagulate the tissue surrounding the core biopsy channel during withdrawal to reduce or 
eliminate significant post-procedural bleeding. Currently, the Kronos Electrocautery Device 
consists of one (1) size. As such, the existing Kronos Electrocautery Device is chosen as the 
worst-case condition.  
 

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Figure 1: Kronos Electrocautery Device 
 
 
10 Study Procedures 
 
10.1 Visit 1 (Screening and Enrollment up to the day of Biopsy) 
 
1.  Review of the medical record to confirm the patient meets study enrollment criteria 
2. Informed Consent - Patients will be identified during their preoperative appointment and 
introduced to the study; they will be provided with a copy of the consent document and 
information about the study. The consenting will take place after additional discussion on the 
day of procedure. 
3. Screening will include past and current medical history, a physical examination, blood labs 
(including Platelet account, INR, Fibrinogen, aPTT and other tests may be considered as 
needed), and history of current medications.  Lab testing is performed prior, as standard of 
care, to determine if someone may have an undiagnosed bleeding disorder related to their 
current medical condition prior to participation. 
 
 
10.2 Visit 2 (Treatment – Day of Biopsy procedure) 
 
1. Ultrasound guided percutaneous biopsy will be performed as per standard of care 
2. Placement of the desired core biopsy needle and guide needle will be as per standard of care 
3. The needle will be removed, leaving the guide needle in place. 
4. Biopsy forceps will be advanced through the guide needle to obtain the tissue 
5. The biopsy forceps will be removed with the tissue 
6. Remove Kronos Electrocautery Device from packaging and visually inspect.  Record 
Device Condition score per Attachment 1 – Kronos Scoring Criteria 
7. Using the current Instruction for Use (IFU), the Kronos Electrocautery Device will be 
advanced to a predetermined length (recorded) to ensure that it protrudes into the biopsy 
track.  Record Maneuverability to Target Tissue score per Attachment 1 – Kronos Scoring 
Criteria. If Guide needle was used, record Compatibility with guide needle score per 
Attachment 1 – Kronos Scoring Criteria   
8. The Kronos Electrocautery Device will be activated, and the device and guide needle will 

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be withdrawn simultaneously at controlled speed. The total time of withdrawal (recorded ).  
Record Withdrawal Force score per Attachment 1 – Kronos Scoring Criteria 
9. Any blood or fluids from the access site will be soaked up with a dry gauze without placing 
any pressure on the access site. 
10. Blood or other fluids will be collected for a minimum of five minutes, or until all bleeding 
has stopped (if applicable). The gauze will be weighed (recorded)to estimate the blood loss 
with results. Record Device Performance (Blood control) score per Attachment 1 – Kronos 
Scoring Criteria. 
11. This procedure will be performed a single  time, on areas that include, but are not limited to, 
liver, kidney, lungs, breasts, soft tissue, etc.,.. The biopsy procedure is being performed as a 
standard of care, which may require multiple passes. 
 
10.3 Schedule of Events 
 
 
 
Schedule of Events 
Study Activity 
Screening/Baseline 
          Procedure 
Follow-up 
Informed consent 
X 
 
 
Medical History 
X 
 
 
Eligibility criteria 
X 
 
 
Index data collection 
 
X 
X 
Adverse event 
evaluation 
 
X 
X 
 
 
11 Statistical Plan 
 
11.1 Sample Size  
 
No formal statistical hypothesis is proposed for this study. A non-statistically driven sample 
size of 30 patients is considered sufficient for this pilot study.  
11.2  Handling of Missing Data 
 
This is a prospective acute outcomes study and therefore we do not anticipate any missing data. 
In the event of any unexpected missing data, no attempt to impute this missing data will be 
made. Missing data will simply be treated as missing in the statistical analysis. 
 
12. Safety and Adverse Events 
 
12.1 Definitions 
 
12.1.1 Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO) 

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Any unanticipated problem or adverse event that meets the following three criteria: 
• Serious: Serious unanticipated problems or events that result in significant harm, (which 
may be physical, psychological, financial, social, economic, or legal) or increased risk for 
the subject or others (including individuals who are not research subjects). These include: 
(1) death; (2) hemorrhage or life threatening adverse experience; (3) hospitalization - 
inpatient, new, or prolonged; (4) disability/incapacity - persistent or significant; (5) birth 
defect/anomaly; (6) breach of confidentiality and (7) other problems, events, or new 
information (i.e. publications, DSMB reports, interim findings, product labeling change) 
that in the opinion of the local investigator may adversely affect the rights, safety, or welfare 
of the subjects or others, or substantially compromise the research data, AND 
• Unanticipated: (i.e., unexpected) problems or events are those that are not already described 
as potential risks in the protocol, consent document, not listed in the Investigator’s 
Brochure, or not part of an underlying disease. A problem or event is "unanticipated" when 
it was unforeseeable at the time of its occurrence. A problem or event is "unanticipated" 
when it occurs at an increased frequency or at an increased severity than expected, AND 
• Related: A problem or event is "related" if it is possibly related to the research procedures. 
 
12.1.2 Adverse Event 
 
An untoward or undesirable experience associated with the use of a medical product 
(i.e. drug, device, biologic) in a patient or research subject. 
 
 

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12.1.3 Serious Adverse Event 
 
Adverse events are classified as serious or non-serious. Serious problems/events can be 
well defined and include: 
• death 
• hemorrhage 
• life threatening adverse experience 
• hospitalization 
• inpatient, new, or prolonged; disability/incapacity 
• persistent or significant disability or incapacity 
• birth defect/anomaly 
All adverse events that do not meet any of the criteria for serious, should be regarded 
as non- serious adverse events. 
 
12.1.4 Adverse Event Reporting Period 
 
             For this study, the follow-up period is defined as up to 30 days post-procedure. 
 
12.1.5 Preexisting Condition 
 
A pre-existing condition is one that is present before the start of the study. A pre-existing 
condition should be recorded as an adverse event if the frequency, intensity, or the character 
of the condition worsens during the study period. 
12.2 Recording of Adverse Events 
 
At each contact with the subject, the study team must seek information on adverse events 
by specific questioning and, as appropriate, by examination. Information on all adverse 
events should be recorded immediately in the source document, and also in the appropriate 
adverse event section of the electronic case report form (CRF). All clearly related signs, 
symptoms, and abnormal diagnostic, laboratory or procedure results will be recorded in the 
source document. 
 
 All adverse events occurring during the study period must be recorded. The clinical course 
of each event should be followed until resolution, stabilization, or until it has been ultimately 
determined that the study treatment or participation is not the probable cause. Serious 
adverse events that are still ongoing at the end of the study period must be followed up, to 
determine the final outcome. Any serious adverse event that occurs during the Adverse 
Event Reporting Period and is considered to be at least possibly related to the study 
treatment or study participation should be recorded and reported immediately. 
 

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12.3 Reporting of Serious Adverse Events and Unanticipated Problems 
 
When an adverse event has been identified, the study team will take appropriate action 
necessary to protect the study participant and then complete the appropriate documentation. 
The site’s Principal Investigator  will evaluate the event and determine the necessary follow-
up and reporting required. 
 
12.3.1 Principal Investigator reporting notifying the IRB 
 
 The site’s Principal Investigator  will report to the IRB any UPIRTSOs and Non-UPIRTSOs 
according to the IRB Policy and Procedures. Any serious adverse event (SAE) which the 
Principal Investigator has determined to be a UPIRTSO will be reported to the IRB as soon as 
possible but no later than 5 working days after the investigator first learns of the problem/event. 
 
 The following information will be collected on the adverse event worksheet (and entered in 
the research database): 
• Study ID 
• Disease 
• The date the adverse event occurred 
• Description of the adverse event 
• Relationship of the adverse event to the research device* 
• Determination if the adverse event was expected 
• The severity of the adverse event (severity scale described below**) 
• If any intervention was necessary 
• Resolution (was the incident resolved spontaneously, or after discontinuing treatment) 
• Date of Resolution 
 
The site’s Principal Investigator will review all adverse event reports to determine if specific 
reports need to be made to the IRB and FDA. The site’s Principal Investigator  will sign and 
date the adverse event report when it is reviewed. For this protocol, only directly related 
SAEs/UPIRTSOs will be reported to the IRB. 
 
           * Relationship Index 
 
The relationship of an AE to the Investigational Device is a clinical decision by the site’s 
Principal Investigator based on all available information at the time of the completion of the 
CRF’s and is graded as follows: 
 
1. Not related: a reaction for which sufficient information exists to indicate that the 
etiology is unrelated to the study device. 
 

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2. Unlikely: a clinical event, including laboratory test abnormality, or underlying disease 
provide plausible explanations. 
 
3. Possible: a clinical event, including laboratory test abnormality, with a reasonable time 
sequence to use of study device but which could also be explained by concurrent disease 
or other drugs/devices or chemicals. 
 
4. Probable: a clinical event including laboratory test abnormality, with a reasonable time 
sequence to use of the device, unlikely to be attributed to concurrent disease or other 
devices or chemicals. 
 
5. Definite: a reaction that follows a reasonable temporal sequence from use of the device. 
 
           ** Severity Scale 
 
The maximum intensity of an AE should be graded according to the definitions below and 
recorded in detail as indicated on the CRF. If the intensity of an AE changes over a number 
of days, then separate entries should be made having distinct onset dates. 
 
1. Mild: AEs are usually transient, requiring no special treatment, and do not interfere      
with patient’s daily activities. 
 
2. Moderate: AEs typically introduce a low level of inconvenience or concern to the patient 
and may interfere with daily activities but are usually ameliorated by simple therapeutic 
measures. 
 
3. Severe: AEs interrupt a patient's usual daily activity and traditionally require systemic   
              drug therapy or other treatment. 
 
 
12.4 Medical Monitoring 
 
It is the responsibility of the Principal Investigator to oversee the safety of the study at his/her 
site. This safety monitoring will include careful assessment and appropriate reporting of 
adverse events as noted above, as well as the construction and implementation of a site data 
and safety-monitoring plan, medical monitoring will include a regular assessment of the 
number and type of serious adverse events. 
 
 

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13 Data Handling and Record Keeping 
 
13.1 Confidentiality 
 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 
Those regulations require a signed subject authorization informing the subject of the 
following: 
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research subject to revoke their authorization for use of their PHI. 
 
  In the event that the subject revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of subject 
authorization. For subjects that have revoked authorization to collect or use PHI, attempts 
should be made to obtain permission to collect at least vital status (long term survival status 
that the subject is alive) at the end of their scheduled study period. 
 
13.2 Source Documents 
 
Source data is all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source 
data are contained in source documents. Examples of these original documents and data 
records include hospital records and any forms completed specifically for this study. 
 
13.3 Case Report Forms 
 
CRFs will be developed to collect study-specific data points. 
 
 
13.4 Data Management 
 
Study data to be collected and managed using EHR and transcribed into electronic CRFs in an 
electronic data capture system that is a secure, web-based application designed to support data 
capture for research studies.  
 
13.5 Data Processing 
 
All study data will be stored within the electronic data capture system. The principal investigator 
will be responsible for overseeing the analysis of the data. De-identified data will be shared with 
the study sponsor. 

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13.6 Data Security and Confidentiality 
 
All source documents including clinical findings, observations or other activities will be stored 
in an electronic database and overseen by the Investigator. Access to the database will be limited 
to the Principal Investigator, Investigators, Study Team members, and Statistician. 
 
13.7 Data Quality Assurance 
 
Once the study is completed, the Principal Investigator will randomly select 1 participant and 
compare the data documented in the EHR with what is entered into the electronic database. If there 
is any discrepancy, the Principal Investigator and/or Investigators will cross-reference all patients 
to ensure accuracy. 
 
13.8 Data Clarification Process 
 
For any data query, the site’s Principal Investigator and Sub-Investigators will meet to clarify 
the data queried and make corrections based on consensus. 
 
13.9 Records Retention 
 
The site’s Principal Investigator will maintain records and essential documents related to the 
conduct of the study. These will include subject case histories and regulatory documents. The 
site’s Principal Investigator  will retain the specified records and reports. 
 
14 Study Monitoring, Auditing, and Inspecting 
 
14.1 Study Monitoring Plan 
 
The site’s Principal Investigator will allocate adequate time for such monitoring activities. 
The Principal Investigator will also ensure that the compliance or quality assurance reviewer 
is given access to all the study-related documents. 
 
14.2 Auditing and Inspecting 
 
The investigator will permit study-related monitoring, audits, and inspections by the IRB, 
the sponsor, and government regulatory agencies, of all study related documents (e.g. 
source documents, regulatory documents, data collection instruments, study data etc.). 
Participation as a Principal Investigator or Sub-Investigator in this study implies 
acceptance of potential inspection by government regulatory authorities and applicable 
compliance offices. 
 
 

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15 Ethical Considerations 
 
This study is to be conducted according to United States government regulations 
and Institutional research policies and procedures and the requirements of the 
Regulation (EU) 2017/745 Chapter VI and Annex XV. 
 
This protocol and any amendments will be submitted to a properly constituted local 
Institutional Review Board (IRB)/EC, in agreement with local legal prescriptions, for formal 
approval of the study. The decision of the IRB concerning the conduct of the study will be 
made in writing to the site’s Principal Investigator  before commencement of this study. 
 
All subjects for this study will be provided a consent form describing this study and providing 
sufficient information for subjects to make an informed decision about their participation in 
this study. This consent form will be submitted with the protocol for review and approval by 
the IRB/EC for the study. The formal consent of a subject, using the Approved IRB/EC consent 
form, must be obtained before that subject undergoes any study procedure.  The consent form 
must be signed by the subject and the individual obtaining the informed consent. 
 
16 Study Finances 
 
16.1 Funding Source 
     Single Pass, Inc. is the funding sponsor of this study. 
 
 
16.2 Conflict of Interest 
 
Any study team member who has a conflict of interest with this study (patent ownership, 
royalties, or financial gain greater than the minimum allowable by their institution, etc.) 
will have the conflict reviewed by a properly constituted Conflict of Interest Committee 
with a Committee-sanctioned conflict management plan that has been reviewed and 
approved by the study site’s Principal Investigator  prior to participation in this study. 
 
16.3 Subject Stipends or Payments 
 
Subjects may receive a stipend payment for participation, but only within a fair and reasonable 
amount.  
 
 
 

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17 Publication Plan 
 
The primary responsibility for publication of the study results is with the Primary Investigator. 
After the completion of study and prior to publication, the study results will be shared with all 
Investigators. The study will be registered at ClinicalTrials.gov prior to subject recruitment 
along with the posting of the results within 12 months of final data collection for the primary 
outcome measure if required by Compliance Office and applicable laws and regulations. 
 
18 References 
 
1. Whittier WL, Korbet SM. Timing of complications in percutaneous renal biopsy. J Am Soc 
Nephrol. 2004;15(1): 142–7.  
2. Manno C, Strippoli GF, Arnesano L, Bonifati C, Campobasso N, Gesualdo L, et al. Predictors 
of bleeding complications in percutaneous ultrasound-guided renal biopsy. Kidney Int. 
2004;66(4):1570–7 
3. Mahal AS, Knauer CM, Knauer M, Gregory PB. Bleeding after Liver Biospy. West J Med 
1981;134:11-14.  
4. Sanghyeok Lim, Hyunchul Rhim, Min Woo Lee, Kyoung Doo Song, et al. New 
Radiofrequency Device to Reduce Bleeding after Core Needle Biopsy: Experimental Study in a 
Porcine Liver Model. Radiol 2017;18(1):173-179. 
5. *Pub Med review of 156 published articles detailing 371,947 biopsy procedures 
 
 
 

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19 Attachments 
 
1. Attachment A: Kronos Scoring Criteria 
 
 
Attachment A: Kronos Scoring Criteria 
 
Attribute 
Score 
1 
Unacceptable 
2 
Unsatisfactory 
3 
Acceptable 
4 
Good 
5 
Excellent 
 Device Condition 
(Visual Inspection) 
Device was unable 
to prepare. Device 
was unable to 
connect for use  
Device was difficult 
to prepare. Device 
was difficult to 
connect to fittings 
with insecure 
connection  
Device was easy to 
prepare. Device 
was able to 
connect to fittings 
with some issues 
Device was easy to 
prepare. Device 
was able to 
connect to fittings 
with slight issue 
Device was easy to 
prepare. Device 
was able to 
connect to fittings 
without issue 
Maneuverability to 
Target Tissue 
Device was unable 
to maneuver to 
target tissue  
Device was difficult 
to maneuver to 
target tissue   
Device was able to 
maneuver to target 
tissue with some 
issue  
Device was able to 
maneuver to target 
tissue with slight 
issue  
Device was able to 
maneuver to target 
tissue without 
issue  
Device Performance 
(Blood Control) 
Device was unable 
to cease blood at 
target vessel 
Device was able to 
cease blood at 
target vessel with 
great difficulty  
Device was able to 
cease blood at 
target vessel with 
some issue  
Device was able to 
cease blood at 
target vessel with 
slight issue  
Device was able to 
cease blood at 
target vessel 
without issue  
Compatibility with 
Guide Needle 
Device was unable 
to track through 
guide needle 
Device was able to 
track through 
guide needle with 
a lot of friction 
Device was able to 
track through 
guide needle with 
some friction 
Device was able to 
track through 
guide needle with 
slight friction 
Device was able to 
track through 
guide needle 
without friction 
Withdrawal Force 
Device was unable 
to be removed 
from target vessel  
Device was able to 
be removed from 
target vessel with a 
lot of friction 
Device was able to 
be removed from 
target vessel with 
some friction 
Device was able to 
be removed from 
target vessel with 
slight friction 
Device was able to 
be removed from 
target vessel 
without friction