Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis
Phase: NA
Conditions: Crohn's Disease of Large Intestine, Malignant Neoplasm of Colon
Sponsor: Weill Medical College of Cornell University

TITLE:  Evaluation of Ability to Detect Bowel Gas during Laparoscopic Right Colectomy with 
Intracorporeal Anastomosis  
IRB Protocol #: 20-10022823 
NCT#:NCT04964297
Version Date: 06/03/2024 
Funding Source(s): Sentire Medical Systems, Inc., USA 

Page # i 
TITLE:  Evaluation of Ability to Detect Bowel Gas during Laparoscopic Right Colectomy with 
Intracorporeal Anastomosis  
IRB Protocol #: 20-10022823 
IND/IDE #: (if applicable) 
Version Date: 06/03/2024 
Funding Source(s): Sentire Medical Systems, Inc., USA 
Principal Investigator: 
Mehraneh Dorna Jafari, MD 
 525 East 68th Street, K-802A 
 New York, NY 10065  
646-962 2342
Co-Investigators: 
 Jeffrey Milsom, MD 
 Professor of Surgery 
 525 East 68th Street, K-802 
 New York, NY 10065 
 646 962 2270 
Parul J .Shukla, MD 
 Professor of Surgery 
 525 East 68th Street, K-802 
 New York, NY 10065 
  646 962 2270 
Kelly Garrett, MD 
 Associate Professor of Clinical Surgery 
 525 East 68th Street, K-802 
 New York, NY 10065 
 646 962 2270 
Heather Yeo, MD 
 Associate Professor of Surgery 
 525 East 68th Street, K-802 
 New York, NY 10065 
 646 962 2270 
Lea Lowenfeld, MD 
 Assistant Professor of Surgery 
 525 East 68th Street, K-802 
 New York, NY 10065 
 646 962 2270 
 Koiana Trencheva, BSN, M.S. 
 Research Associate  
 525 East 68th Street, K-802B 
 New York, NY 10065  
646-962 2342

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    kivanova@med.cornell.edu 
 
Elain Darling, CNP OCN 
    Nurse Practitioner  
 
    525 East 68th Street, K-802 
 
    New York, NY 10065 
 
    646-962-3037 
 
Wooyon Choi 
   Research Assistant 
 
   525 East 68th Street, K-801 
 
   New York, NY 10065 
       
 
   646-962 2789 
 
   woc4001@med.cornell.edu 
 
Kristina Hosi. 
   Clinical Trials Program Manager, 
 
   Department of Surgery 
 
   Tel: 646.962.9417 
 
    krh7011@med.cornell.edu  
 
Statistician:                              Paul J. Christos, Dr. P.H., M.S. 
Director, Research Design and Biostatistics Core,  
Clinical and Translational Science Center 
Division of Biostatistics and Epidemiology 
Department of Healthcare Policy and Research 
Weill Cornell Medical College  
 
                                            pac2001@med.cornell.edu 
Medical Monitor: N/A 
 
Participating Sites:                 Weill Cornell Medicine, 
                                                  PI: Mehraneh Dorna Jafari, MD 
                                                  646-962 2342 
 
 

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Table of Contents 
CONFIDENTIALITY STATEMENT .......................................................................................... VII 
LIST OF ABBREVIATIONS ..................................................................................................... VIII 
1. PROTOCOL SUMMARY ........................................................................................................ 1 
1.1 
Schema ..............................................................................................................................3 
1.2 
Study Objectives and End Points ...................................................................................5 
1.2.1  Primary Objectives ....................................................................................................5 
1.2.2  Secondary Objectives ...............................................................................................5 
1.2.3  Exploratory Objectives ..............................................................................................5 
1.2.4 
Primary Endpoints .....................................................................................................5 
1.2.5 
Secondary Endpoints ................................................................................................5 
2. BACKGROUND ........................................................................................................................ 6 
2.1 
Disease ...............................................................................................................................6 
2.2 
Investigational Agent/Device, or Surgical Treatment/Method ...................................6 
2.3 
Rationale ............................................................................................................................8 
2.4 
 Risk/Benefit Assessment ................................................................................................8 
2.4.1 Known Potential Risks ..................................................................................................8 
2.4.2 Known Potential Benefits .............................................................................................9 
2.4.3 Assessment of Potential Risks and Benefits .............................................................9 
2.5 
Correlative Studies Background .....................................................................................9 
3. STUDY DESIGN .................................................................................................................... 10 
3.1 
Overall Design .................................................................................................................10 
3.2 
Scientific Rationale for Study Design ..........................................................................10 
3.3 
Justification for Dose ......................................................................................................10 
3.4 
End of Study Definition ..................................................................................................11 
4. SUBJECT SELECTION ........................................................................................................ 11 
4.1 
Study Population .............................................................................................................11 
4.2 
Inclusion Criteria .............................................................................................................11 
4.3 
Exclusion Criteria ............................................................................................................11 
4.4 
Lifestyle Considerations .................................................................................................11 
4.5 
Screen Failures ...............................................................................................................11 
4.6 
Strategies for Recruitment and Retention...................................................................12 
5. REGISTRATION PROCEDURES ....................................................................................... 12 
5.1 
Subject Registration (WCM only) .................................................................................12 
5.2 Subject Registration (Sub-sites) .......................................................................................12 
6. STUDY PROCEDURES ....................................................................................................... 12 

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6.1 
Schedule of Assessments .............................................................................................12 
6.1.1 
Screening Visit (-X days before start of treatment) ............................................13 
6.1.2.    Day of Surgery .........................................................................................................13 
Procedure Stage ...........................................................................................................................13 
Sample # .......................................................................................................................................13 
Time of collection .........................................................................................................................13 
H2 .................................................................................................................................................13 
CH4 ...............................................................................................................................................13 
CO2 ...............................................................................................................................................13 
CO2 flow/rate ...............................................................................................................................13 
Intraabdominal Pressure (mmHg) ................................................................................................13 
Volume .........................................................................................................................................13 
Re-Insufflation ..............................................................................................................................13 
Y_N ...............................................................................................................................................13 
Anesthetic gases ...........................................................................................................................14 
6.1.3 
Follow-up Phase ......................................................................................................14 
7. STUDY INTERVENTION ...................................................................................................... 14 
7.1 
Study Intervention/Device Description ........................................................................14 
7.2 
Availability ........................................................................................................................14 
7.3 
Acquisition and Accountability ......................................................................................14 
7.10 Duration of Follow Up ......................................................................................................15 
7.11 Measures to Minimize Bias: ............................................................................................15 
This is a prospective pilot interventional, single-center, single-arm, open-label, phase 1 
investigator-initiated study to determine device ability to detect bowel gas during 
laparoscopic right hemicolectomy with intracorporeal anastomosis using Perf-AlertTM 
gas detection system on 20 subjects into 2 Cohorts. To minimize the selection bias, we 
will enroll 20 consecutive subjects willing to participate in the study. The first 10 
subjects will be part of Cohort 1, and the following 10 subjects will be part of Cohort 2.
 ......................................................................................................................................................15 
7.12 Study Intervention/Follow-up Compliance ....................................................................15 
8. STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................................... 15 
8.1 
Discontinuation of Study Intervention ..........................................................................15 
8.2 
Participant Discontinuation/Withdrawal from the Study ............................................15 
8.3 
Lost to Follow Up ............................................................................................................16 
9. CORRELATIVE/SPECIAL STUDIES .................................................................................. 16 
9.1 
Laboratory Correlative Studies .....................................................................................16 
9.1.1 
Title – Laboratory Correlative Study #1 ...............................................................16 
9.1.1.1 
Collection of Specimen(s) ..................................................................................16 
9.1.1.2 
Handling of Specimen(s) ....................................................................................16 
9.1.1.3 
Shipping of Specimen(s) (if multicenter) ..........................................................16 

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9.1.1.4 
Site(s) Performing Correlative Study (if multicenter) ......................................16 
9.2 
Special Studies ...............................................................................................................16 
9.2.1 
Title – Special Correlative Study #1 .....................................................................16 
9.2.1.1 
Assessment ..........................................................................................................16 
9.2.1.2 
Method of Assessment .......................................................................................16 
9.2.1.3 
Timing of Assessment .........................................................................................16 
10.  MEASUREMENT OF EFFECT ........................................................................................ 16 
10.1 Response Criteria .............................................................................................................16 
10.2 Duration of Response ......................................................................................................16 
10.3 Progression-Free Survival ...............................................................................................16 
10.4 Other Response Parameters ..........................................................................................16 
11. DATA REPORTING / REGULATORY CONSIDERATIONS ........................................ 16 
11.1 Data Collection ..................................................................................................................16 
11.1.1 Microsoft Access .......................................................................................................17 
11.2 Regulatory Considerations ..............................................................................................17 
11.2.1 Institutional Review Board/Ethics Committee Approval ......................................17 
11.2.2 Ethical Conduct of the Study ...................................................................................18 
11.2.3 Informed Consent ......................................................................................................18 
11.2.4 Compliance with Trial Registration and Results Posting Requirements ..........18 
11.2.5 Record Retention ......................................................................................................18 
12. STATISTICAL CONSIDERATIONS .................................................................................. 18 
12.1 Study Design/Endpoints ..................................................................................................19 
12.2 Sample Size/Accrual Rate ..............................................................................................20 
12.3 Stratification Factors ........................................................................................................20 
No stratification factors and no interim analysis will be done. ............................................20 
12.4 Analysis of Endpoints .......................................................................................................20 
12.4.1 
Analysis of Primary Endpoints ...........................................................................20 
12.4.2 
Analysis of Secondary Endpoints ......................................................................21 
12.5 Interim Analysis .................................................................................................................21 
12.6 Reporting and Exclusions ...............................................................................................21 
12.6.1 
Evaluation of Toxicity ..........................................................................................21 
12.6.2 
Evaluation of Response ......................................................................................21 
13. ADVERSE EVENT REPORTING REQUIREMENTS .................................................... 21 
13.1 Adverse Event Definition .................................................................................................21 
13.1.1 
Investigational Agent or Device Risks (Expected Adverse Events) ............22 
13.1.2 
Adverse Event Characteristics and Related Attributions ...............................22 
13.1.3 
Recording of Adverse Events ............................................................................22 
13.1.4 
Reporting of AE to WCM IRB ............................................................................23 
13.1.5 
Reporting Events to Participants .......................................................................23 

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Not Applicable. .......................................................................................................................23 
13.1.6 
Events of Special Interest- .................................................................................23 
Not Applicable. .......................................................................................................................23 
13.1.7 
Reporting of Pregnancy ......................................................................................23 
13.2 Definition of SAE ...............................................................................................................23 
13.2.1 
Reporting of SAE to IRB .....................................................................................23 
13.2.2 
Reporting of SAE to FDA [For Protocols Where WCMC is the Sponsor-
Investigator] ............................................................................................................................23 
13.2.3 
Reporting of SAE to Sentire Medical Systems, Inc. .......................................24 
13.3 AE/SAE Follow Up ...........................................................................................................24 
13.4 Time Period and Frequency for Event Assessment and Follow Up .........................24 
14. UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS24 
14.1 Definition of Unanticipated Problems Involving Risks to Subjects or Others 
(UPIRTSO) .................................................................................................................................24 
14.1.2 
Unanticipated Problem Reporting .....................................................................25 
15. DATA AND SAFETY MONITORING PLAN (DSMP) ..................................................... 25 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Statement of Compliance 
 
 
(1) [The trial will be conducted in accordance with International Conference on Harmonization 
Good Clinical Practice (ICH GCP), applicable United States (US) Code of Federal 
Regulations (CFR), and the <specify NIH Institute or Center (IC) > Terms and Conditions 
of Award. The Principal Investigator will assure that no deviation from, or changes to the 
protocol will take place without prior agreement from the Investigational New Drug (IND) 
or Investigational Device Exemption (IDE) sponsor, funding agency and documented 
approval from the Institutional Review Board (IRB), except where necessary to eliminate 
an immediate hazard(s) to the trial participants. All personnel involved in the conduct of 
this study have completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials 
will be submitted to the IRB for review and approval.  Approval of both the protocol and 
the consent form must be obtained before any participant is enrolled.  Any amendment to 
the protocol will require review and approval by the IRB before the changes are 
implemented to the study.  All changes to the consent form will be IRB approved; a 
determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form.] 
 
 
 
 
 
 
Confidentiality Statement 
 
This document is confidential and is to be distributed for review only to investigators, potential 
investigators, consultants, study staff, and applicable independent ethics committees or 
institutional review boards. The contents of this document shall not be disclosed to others without 
written authorization from WCM, unless disclosure on ClinicalTrials.gov is federally required. 
 
 
 
 
 
 
 
 
 

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List of Abbreviations 
 
 
 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CTSC 
Clinical Translational Science Center  
DSMB 
Data Safety Monitoring Board 
DSMP 
Data Safety Monitoring Plan 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HRBFA 
Human Research Billing Analysis Form 
HUD 
Humanitarian Use Device  
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption  
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
PHI 
Protected Health Information 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
SUSAR 
Suspected Unexpected Serious Adverse Reaction  
UIRTSO 
Unanticipated Problem Involving Risks to Subjects or Others 
WCM 
Weill Cornell Medicine 

Protocol #  
Version Date 06/09/2020 
 
  
Page # 1 
 
1. Protocol Summary 
 
Full Title:  
 
 
 
Evaluation of Ability to Detect Bowel Gas during Laparoscopic Right 
Colectomy with Intracorporeal Anastomosis  
Short Title: 
 
 
 
Perf-AlertTM Pilot Study 
Clinical Phase: 
 
 
I 
Principal Investigator:  
Mehraneh Dorna Jafari, MD 
Study Description:   
Undetected bowel perforation is a rare but dangerous complication of 
laparoscopic surgery. If the injury is not detected and treated at the 
time of the surgical procedure, the patient can suffer severe 
complications, including septic shock and eventually death. Our goal 
is to test a novel device that can detect bowel gas leakage from 
perforation and alert the surgeon during the operation by evaluating 
the gases present in the insufflated abdomen during surgery.  This 
study will determine the ability of the device to be attached to a 
standard trocar during the operation and periodically draw small 
samples or aliquots of gas from the abdomen to evaluate the gas 
and accurately detect gaseous content from the bowel. Before the 
device can be used to detect bowel perforations, we must first 
ensure that it can accurately detect bowel gas in an insufflated 
abdomen. 
Sample Size: 
 
N= 20  
Enrollment: 
 
This study will enroll 20 subjects and screen up to 50 subjects.   
Study Population: 
 
Participants of any gender over the age of 18 undergoing 
laparoscopic right colectomy with intracorporeal anastomosis 
procedures for regular care of their medical condition. 
Enrollment Period:  
12 months  
Study Design: 
 
Prospective pilot, interventional, single-center, single arm, open- 
label, investigator-initiated study of 20 subjects in 2 cohorts: Cohort 
1- 10 subjects and Cohort 2- 10 subjects, to determine device ability 
to detect bowel gas during laparoscopic right hemicolectomy with 
intracorporeal anastomosis.  
Description of Sites/            Single site study 
Facilities Enrolling  
Weill Cornell Medicine  
Participants: 
 
20   
 
Study Duration: 
           14 months from initiation to study completion (12 months accrual, 2 
months data analyses and presentation). 
Participant Duration: 
4-6 weeks. From enrollment and consent during preoperative clinic 
visit (Visit 1) and during surgery (Visit 2). Data will be gathered 
preoperatively and intraoperatively during the laparoscopic right 
colectomy. 
Study Agent/Device Name   Perf-AlertTM, Sentire Medical Systems, Inc., USA 
Intervention Description: 
The anesthesia and the laparoscopic surgical procedure will be 
performed as per standard of care. Perf-AlertTM was developed by 
Sentire Medical Systems, Inc., USA. The Perf-AlertTM prototype 

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consists of a 15” x 13” x 7” unit containing gas sensors and valves, a 
small box containing a one-way, ultra-low pressure pump, user 
controls (buttons), and software algorithms, which control the 
operation of the device. It is used in conjunction with a single-use, 
disposable kit consisting of sterile tubing and filters used for sample 
collection and transport. The sensing unit will be connected via a 
sterile tube/filter set to any trocar port in use during the procedure. At 
specific time points during the procedure, a one-way valve will be 
opened, and the unit’s pump turned on and withdrawing a small 
aliquot of gas from the abdominal cavity to the sensing unit. The 
system’s architecture is configured such that sample collection, 
transport, analysis, and feedback occur in a single step such that 
sample collection and sensor feedback occur in real-time. A standard 
laptop running an analytical software program is connected to the 
unit to record and log sensor readings.  
Primary Objective: 
The primary objective of this study is to test the Perf-AlertTM device’s 
ability to detect, in humans, bowel gas leakage [Hydrogen (H2) and 
Methane (CH4)] into an insufflated abdomen during laparoscopic 
right colectomy with intracorporeal anastomosis 
 
Secondary Objectives: 
The secondary objective of this study is to determine response time 
of the Perf-AlertTM device.  
 
 
Exploratory Objectives: 
N/A  
 
Primary Endpoints: 
Presence of Hydrogen (H2) and Methane (CH4) gas measured in 
ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8 time 
points during the surgery: 
 
1) Initiation of surgery/laparoscopy start Insufflation 
2) Abdominal exploration 
3) Completion of colon mobilization  
4) Colon transection  
5) At Colotomy 
6) At Enterotomy 
7) Anastomosis completion 
8) End of surgery- after re-insufflation before closure 
 
All data to be analyzed will be gathered during a single surgical 
procedure    
 
 
Secondary Endpoints:         The response time of the Perf-AlertTM device measured in seconds 
from obtaining the sample (from opening the valve to obtain sample) 
to first detecting a gas presence at the device electronic sensors. 
       

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Covariates:    
              Demographics 
                                                 Preoperative Diagnosis 
 
  Existing Medical Conditions  
  Statin drugs in the last 3 months 
  Antibiotics in the last 3 months 
  Intra-abdominal pressure 
 
 
 
 
  Anesthetic gases 
 
 
 
 
  Total CO2 volume 
 
 
 
 
  Intraoperative complications 
 
 
 
1.1 Schema 
 
 
 
 
 
 
 

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Prior to 
Enrollment 
 
 
 
 
 
 
 
  
 
 
 
Surgery  
Initiation 
Time Point 
 
 
 
 
 Post Inssuflation  
 Time Point 
 
 
 
 
Time points 
For Sample  
Collection 
 
 
 
 
 
 
 
End of 
Surgery 
Time Point 
 
 
 
 
 
Post 
Operative 
 
 
 
Total N:  Obtain informed consent. Screen potential participants by inclusion and 
exclusion criteria; obtain history, vital stats (age, gender, height, weight, BMI) 
document. 
Connect Perf’AlertTM to Operative Trocar Port 
Sterile tube/filter assembly to be opened in sterile field and affixed to accessible trocar 
port via standard leur connection ensuring air-tight seal. Surgeon or OR nurse will 
hand the other end of the tube to the Perf-AlertTM operator for connection. 
Prior to conclusion of surgery and removal of trocars, repeat Sample Collection procedure. 
1) 
Initiation of surgery/laparoscopy start Insufflation 
2) 
Abdominal exploration 
3) 
Completion of colon mobilization  
4) 
Colon transection  
5) 
At Colotomy 
6) 
At Enterotomy 
7) 
Anastomosis completion 
8) 
End of surgery- after re-insufflation before closure 
Final Assessments 
Statistical analysis to be performed on gas 
concentration measurements collected   
 
Arm 1 
20 participants 
 
Post insufflation but prior to initiation of surgical procedure, initiate Sample 
Collection as follows:  1. Open valve of trocar port to allow abdominal gas to pass 
through. 2. Open valve at Perf-AlertTM and initiate sample collection by turning on 
pump – let run for 60 seconds. 3. Close valve of trocar to stop the flow of gas from the 
abdomen.

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1.2 Study Objectives and End Points 
 
1.2.1  Primary Objectives  
 
To test the Perf-AlertTM device’s ability to detect, in humans, bowel gas leakage 
[Hydrogen (H2) and Methane (CH4)] into an insufflated abdomen during laparoscopic 
right large intestinal surgery with intracorporeal anastomosis.  
 
1.2.2  Secondary Objectives  
 
       The secondary objective of this study is to determine response time of the Perf-AlertTM 
device. 
1.2.3  Exploratory Objectives 
 
 
 
N/A 
 
 
1.2.4 Primary Endpoints 
 
The primary end points are the presence of Hydrogen (H2) and Methane (CH4) gas 
measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8 time points 
during the surgery. 
 
1) Initiation of surgery/laparoscopy start Insufflation 
2) Abdominal exploration 
3) Completion of colon mobilization  
4) Colon transection  
5) At Colotomy 
6) At Enterotomy 
7) Anastomosis completion 
8) End of surgery- after re-insufflation before closure      
 
Initiation of surgery and end of surgery.  All data to be analyzed will be gathered during 
a single surgical procedure. 
 
 
1.2.5 Secondary Endpoints 
 
The response time of the Perf-AlertTM device measured in seconds from obtaining 
the sample (from opening the valve to obtain sample) to first detecting a gas 
presence at the device electronic sensors. 
 
1.2.6 Covariates: 
 
  Demographics 
   Preoperative Diagnosis 
   Existing Medical Conditions  
   Statin drugs in the last 3 months 
   Antibiotics in the last 3 months  
   Intra-abdominal pressure 

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   Anesthetic gases 
 Total CO2 volume 
    Intraoperative complications 
 
 
 
2. Background 
 
2.1 Disease 
 
 
Undetected intraoperative bowel injuries are rare but devastating complications of laparoscopic 
surgery. Intraoperative small and large intestinal injuries have been reported in the range of 0.1-
9.2%, and 1.3-4.8% are diagnosed after surgery [1-3]. Multiple risk factors are described in the 
literature to play a role in the iatrogenic bowel injuries such as lysis of adhesions, history of 
previous abdominal surgery, electrocautery, utilization of grasping forceps or scissor, obesity, 
bowel obstruction, and restricted visual field [1-7]. Further, laparoscopic procedures such as large 
bowel resections with anastomosis can often develop leaks leading to similar complications 
including severe morbidity and mortality. The leak test is one method of testing for anastomotic 
leak after completion of bowel anastomosis, although some studies show it has not significantly 
decreased the anastomotic leak occurrence [8]. Another intervention to prevent the occurrence of 
an anastomotic leak or to decrease the severity of the leak after the occurrence is diverting stoma 
creation, with conflicting reports on its role in leak prevention [9]. If the injury is not detected and 
treated at the time of the surgical procedure, the patient can suffer severe complications including 
septic shock and eventually death [1, 7-12].  
 
A novel alternative method for early detection of intraoperative bowel injuries may help to avoid 
or decrease some of the most dreadful postoperative complications such as peritonitis, septic 
shock, and eventually death. Bowel gases Hydrogen (H2) and Methane (CH4) are only two of the 
gases produced in the large intestine as a by-product result of bacterial fermentation [12-13]. 
When the bowel is injured or intentionally opened during surgery, these gases escape into the 
abdominal cavity and could be useful for early detection of bowel injury. Sentire Medical Systems, 
USA has developed a novel device that may be able to detect these gases during surgery. 
Unpublished data from preclinical studies show that the device sensors were able to detect small 
quantities of hydrogen and methane gases within 30 seconds of analysis [12]. The first human trial 
with 8 patients undergoing Roux-en-y gastric bypass reported that hydrogen gas was detected by 
the Sentire device in real-time during surgery, and suggested that the device could be used for the 
detection of iatrogenic intraoperative bowel injuries [12]. 
This study aims to test the Perf-AlertTM device’s ability to detect, in humans, bowel gas leakage 
[Hydrogen (H2) and Methane (CH4)] into an insufflated abdomen during laparoscopic right colon 
surgery with intracorporeal anastomosis. 
 
2.2 Investigational Agent/Device, or Surgical Treatment/Method 
 
Our goal is to test a novel device that can detect bowel gas leakage from perforation and alert the 
surgeon during the operation by evaluating the gases present in the insufflated abdomen during 
surgery.  During laparoscopic surgery, CO2 is inserted into the abdominal cavity in order to 
perform the operation. This is a dynamic process as insufflation is constant during the entire 
procedure to maintain constant pressure and compensate for any small leaks due to the insertion 
and retrieval of instruments.  
 
This study will determine the ability of a novel device to be attached to a standard trocar during the 
operation and periodically draw a small amount of gas from the abdomen to evaluate the gas and 

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accurately detect gaseous content from the bowel. Before the device can be used to detect bowel 
perforations, first we must ensure that it can accurately detect bowel gas in an insufflated 
abdomen. 
 
The Investigational device, Perf-AlertTM, consists of a 15” x 13” x 7” unit containing gas sensors 
and valves, a small box containing a one way, ultra-low pressure pump, user controls (buttons), 
and software algorithms, which control the operation of the device ( Image1).  It is used in 
conjunction with a single-use, disposable kit consisting of sterile tubing and filters used for sample 
collection and transport (Image 2). The sensing unit will be connected via a sterile tube/filter set to 
any trocar port in use during the procedure. At specific time points during the procedure, a one-
way valve will be opened and the unit’s pump turned on pulling small aliquots of gas from the 
abdominal cavity to the sensing unit. The system’s architecture is configured such that sample 
collection, transport, analysis, and feedback occur in a single step such that sample collection and 
sensor feedback occur in real-time.  A standard laptop running an analytical software program is 
connected to the unit to record and log sensor readings. No changes to the device are anticipated 
during the course of the study. 
 
 
 
Image1. Investigational device, Perf-AlertTM  
 
 
 
 
 
 
Image 2. A single use, disposable kit consisting of sterile tubing and filters 
 

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2.3 Rationale 
 
Undetected bowel perforation is a rare but dangerous complication of laparoscopic surgery. If 
the injury is not detected and treated at the time of the surgical procedure, the patient can 
suffer severe morbidity, including septic shock and eventually death. Inadvertent and 
undetected bowel perforations have occurred during laparoscopic surgeries of all types: 
cholecystectomy, hernia repair, hysterectomy, oophorectomy, etc. Further, laparoscopic 
procedures involving the bowel, such as bariatric (foregut) and colorectal (bowel resections and 
anastomosis), can often develop leaks leading to similar complications, including severe 
morbidity and mortality [1, 7-9]. This research is important to the colorectal surgery field as it 
may provide an alternative for early detection of bowel injury or anastomosis leak during the 
intraoperative time, and thus avoid or decrease some of the most dreadful postoperative 
complications such as peritonitis, septic shock, and eventually death. 
 
2.4  Risk/Benefit Assessment  
 
2.4.1 Known Potential Risks 
 
No changes in the care or treatment of the patients will be made as a result of this study, it is only 
intended to be observational, and therefore, minimal risk is anticipated.  The technology being 
studied will not come into direct contact with the patient. A sterile tubing will be connected to the 
trocar in the patient during the operation. As sterile tubing is routinely connected to trocars, there is 
little to no physical risk to the patient. The same type of tubing and setup will be used for 
measurements as the one used for the insufflation of CO2. 
  
Another potential physical risk is the time under anesthesia. The additional amount of time that the 
patient will be under anesthesia due to the collection of the gas samples will be under 5 minutes, 
mitigating any increased risk to the patients due to a long duration under anesthesia.  
  

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Another potential physical risk is the need to ex-sufflate and re-insufflate the abdomen prior to the 
final gas sample collection. Ex-sufflation and re-insufflation occur routinely during laparoscopic 
surgery due to instrument exchange, and since there will be no instruments in the patient during 
this ex-sufflation/re-insufflation, the risk to the patient will be no higher than the risk during the 
regular surgical procedure. The surgeon and study personnel will be responsible for triggering the 
device to sample the intra-abdominal gas at the predefined time points, they will not have direct 
contact with any bodily fluids or gases.  Therefore, we do not anticipate any significant risks or 
exposure risks to the patients or study personnel. 
  
Finally, a previous clinical study involving the roux-en-y bariatric procedure was conducted with no 
adverse patient events [11]’ Information on this study is available at Clinicaltrials.gov 
(https://clinicaltrials.gov/ct2/show/NCT02679118?term=Sentire&cond=Bowel+Perforation&cntry=U
S&rank=1) 
  
  
Another potential risk related to this research is the loss of privacy. However, all the necessary 
measures will be taken to protect the subject's privacy. The electronic data will be kept in 
password-protected computers and the paper data will be stored in a locked cabinet in the locked 
research office located at K802B. 
 
2.4.2 Known Potential Benefits 
 
There will not be any direct benefits to the participating subjects. This device is not intended to 
treat or to alter treatment, therefore we do not expect there to be any benefit to the participating 
subjects in this study. 
 
We hope the information learned from this study will lead to the development of a solution that 
could minimize intraoperative bowel injury and would be of significant benefit to future patients 
and providers. 
 
 
2.4.3 Assessment of Potential Risks and Benefits 
 
Given the potential benefits offered by minimizing one of the most consequential and costly 
complications of laparoscopy, the potential risks of the study are minimal. Specifically, the 
device to be investigated will not come into contact with the patient at any time and is simply 
connected via a standard tube set to a trocar in use during the procedure. The tubing utilized 
is the same as that used to connect the insufflator to the trocar and standard in all 
laparoscopic procedures.  Secondly, the surgeon will not alter the procedure in any way, with 
the exception of 60-90 second pauses at each time point during sample collection. The total 
additional anesthesia time required for each subject will be less than 5 minutes.  We believe 
the benefits of this study overweight the risk. 
 
2.5 Correlative Studies Background 
 
Not Applicable 
 
 
 

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3. Study Design 
 
3.1 Overall Design 
 
Research question: Can detectable levels of bowel gas methane (CH4) and/or hydrogen 
(H2) be detected in the abdominal cavity when the bowel is open during laparoscopic right 
colectomy with intracorporeal anastomosis using Perf-AlertTM detection system? 
 
Research Hypothesis: H1: Bowel gas, methane (CH4) and/or hydrogen (H2) can be 
detected in the abdominal cavity when the bowel is open during laparoscopic right 
colectomy with intracorporeal anastomosis using the Perf-AlertTM detection system. 
 
Design 
Prospective pilot, single-center, single arm, open label, phase 1 investigator-initiated study 
to determine device ability to detect bowel gas during laparoscopic right colectomy with 
intracorporeal anastomosis using Perf-AlertTM gas detection system on 20 subjects into 2 
Cohorts. 
 
Cohort 1: 10 subjects with measurement of bowel gas at 8 predetermined time  
                 points during right laparoscopic colectomy as follow: 
         
1) Initiation of surgery/laparoscopy start Insufflation 
2) Abdominal exploration 
3) Completion of colon mobilization  
4) Colon transection  
5) At Colotomy 
6) At Enterotomy 
7) Anastomosis completion 
8) End of surgery- after re-insufflation before closure      
                  
           Cohort 2:  10 subjects with continuous monitoring of bowel gases through the 
surgery. The level of H2 and CH4 gases will be noted at the 8 predetermined time 
points during the continuous monitoring as well. 
 
 
3.2 Scientific Rationale for Study Design 
 
 
Preliminary investigation of a novel device to detect intraoperative bowel perforation/leak 
during right laparoscopic colectomy.  The study will include a prospective quantitative assessment 
of intra-abdominal gaseous content during intracorporeal anastomosis procedures to determine the 
detectability of bowel gas or lack thereof when the bowel is intact and open. All study participants 
will be subject to the same protocol, and there will be no control group given the nature of the 
study and desired data. Each subject will be its own control using the baseline measurement as 
reference. For a phase one preliminary investigation, this design is appropriate because we cannot 
collect the study samples in a retrospective fashion, and the data from the prospective cohorts will 
provide the necessary information to test the study hypothesis and answer the research question. 
 
3.3 Justification for Dose  
 
Not Applicable 

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3.4 End of Study Definition 
 
A clinical trial is considered completed when participants are no longer being examined or the 
last participant’s last study visit has occurred. For this study it will be after subject 20 has 
completed the surgery. 
A participant is considered to have completed the study if he or she has right laparoscopic 
colectomy with intracorporeal anastomosis completed.  
 
4. Subject Selection 
 
4.1 Study Population 
 
 
Subjects who are undergoing right laparoscopic colectomy with intracorporeal anastomosis 
for regular care of their medical condition, and who meet the inclusion and exclusion criteria will 
be eligible for participation in this study.   
 
4.2 Inclusion Criteria 
 
 
1. Male or female ≥ 18 years of age. 
 
2. Documentation of a required elective right laparoscopic hemicolectomy with 
intracorporeal anastomosis 
      3.  Subject signed inform consent  
 
 
4.3 Exclusion Criteria  
1. Less than 18 years old  
2. Pregnant or breastfeeding 
3. Patients undergoing emergency laparotomy for perforated right colon or trauma  
4. Patients with Intraabdominal abscess, peritonitis or enteric fistula  
5. Patients who are on peritoneal dialysis 
6. Subjects do not speak English  
4.4 Lifestyle Considerations 
 
Not applicable  
 
4.5 Screen Failures  
 
 
Screen failures are defined as participants who consent to participate in the clinical trial but 
are not subsequently randomly assigned to the study intervention or entered in the study. A 
minimal set of screen failure information is required to ensure transparent reporting of screen 
failure participants, to meet the Consolidated Standards of Reporting Trials (CONSORT) 
publishing requirements, and to respond to queries from regulatory authorities. Minimal 
information includes demography, screen failure details, eligibility criteria, and any serious 
adverse event (SAE). 
  
       In this study, subjects who have signed the consent but do not meet the inclusion and 
exclusion criteria listed in sections 4.2 and 4.3 will be considered screen failures. 

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4.6 Strategies for Recruitment and Retention 
 
 
 
The potential subjects for this study will be identified from the practice of the Colon and Rectal 
Surgery, through screening of the daily schedule on EPIC. Subjects scheduled for right 
laparoscopic colectomy with intracorporeal anastomosis for regular treatment of their medical 
condition will be invited to participate in the study. The subjects willing to participate in the study 
will be presented with the research informed consent and introduced to the study. Subject 
understanding of the study will be assessed, and a full understanding of the study has to be 
demonstrated by the subject before they sign consent. The subjects will be recruited during the 
preoperative clinic visit or while in-patient 
We are targeting to recruit 20 subjects, male and female, of all ethnic groups. No vulnerable 
populations will be included in the study. The current colorectal practice includes 8 surgeons, and 
with no competing study, we believe that we will be able to recruit these subjects for 12 months. 
The participants will not be compensated for their participation in the study. Also, there are no 
extra visits that have to be made due to the research study. All the procedures are standard of 
care, except the gas samples. 
 
5. Registration Procedures 
 
5.1 Subject Registration (WCM only) 
 
Subjects will be registered within the WRG-CT as per the standard operating procedure for 
Subject Registration.  
 
 
 
5.2 Subject Registration (Sub-sites) 
 
Not applicable 
 
6. Study Procedures 
 
6.1 Schedule of Assessments 
 
  
Table 1. Schedule of trial events 
 
 
Before Surgery 
Day 0 
 Surgery  
Post op 
 In  Hospital 
 
30 ±2   
days 
Follow Up 
Informed consent 
X 
 
 
 
Inclusion/ Exclusion 
X 
 
 
 
Demographics 
X 
 
 
 
Medical history 
X 
 
 
 
Medication  
X 
 
 
 
Intraoperative data 
 
X 
 
 
Hydrogen H2 Samples 
 
X 
 
 
Methane Samples CH4 
 
X 
 
 
Anesthetic gases 
 
 
 
 

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Post op data  
 
 
X 
X 
 
6.1.1 Screening Visit (30 days before start of treatment) 
 
• 
Informed consent 
• 
Medical history 
• 
Physical exam  
• 
Medications 
• 
Collect vital statistics – age, gender 
 
 
 
 
6.1.2.    Day of Surgery 
• 
Intraoperative data 
• 
Hydrogen H2 Samples 
• 
Methane CH4 Samples  
• 
CO2 flow/rate 
• 
Intraabdominal Pressure (mmHg) 
• 
Anesthetic gases 
• 
Total Volume CO2 
 
 
 
Sample Collection Table 
Procedure Stage  
Laparoscopy 
Start 
Insufflation 
Abdominal 
Exploration 
Completion of  
Colon 
mobilization 
 
Colon 
transection 
At 
Colotomy 
At 
Enteroto
my 
After 
anastomosis 
completion 
Re-Insufflation 
Before Closure 
Sample # 
S1_Baselin
e 
S2 
S3* 
S4* 
S5 
S6 
S7 
S8 
  Time of 
collection  
 
 
 
 
 
 
 
 
H2 
 
 
 
 
 
 
 
 
CH4 
 
 
 
 
 
 
 
 
CO2 
 
 
 
 
 
 
 
 
CO2 
flow/rate 
 
 
 
 
 
 
 
 
Intraabdomin
al Pressure 
(mmHg) 
 
 
 
 
 
 
 
 
Volume 
 
 
 
 
 
 
 
 
Re-
Insufflation 
Y_N 
 
 
 
 
 
 
 
 

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*- Collect sample before smoke evacuation 
 
 
 
 
 
6.1.3 Follow-up Phase 
 
Subjects will be followed postoperatively up to discharge from hospital and once again at 30 ±2 
days after surgery. Relevant post-surgical complications will be collected.  
 
7. Study Intervention 
 
The anesthesia and the laparoscopic right colon surgery will be performed as per standard regular 
care. 
 
7.1 Study Intervention/Device Description   
 
The Perf-AlertTM device consists of a 15” x 13” x 7” unit containing gas sensors and valves, an 
ultra-low pressure pump, user controls (buttons), and software algorithms, which control the 
operation of the device. It is used in conjunction with a single-use, disposable kit consisting of 
sterile tubing and filters used for sample collection and transport. The sensing unit will be 
connected via a sterile tube/filter set to any trocar port in use during the procedure. At specific time 
points during the procedure, a one-way valve will be opened, and the unit’s pump turned on is 
withdrawing small aliquots of gas from the abdominal cavity to the sensing unit. The system’s 
architecture is configured such that sample collection, transport, analysis, and feedback occur in a 
single step such that sample collection and sensor feedback occur in real-time.  A standard laptop 
running an analytical software program is connected to the unit to record and log sensor readings. 
The device will sit outside the sterile operative field and operated by a study coordinator with a 
representative of the device manufacturer present in the operating for troubleshooting. 
 
7.2 Availability 
 
Perf-AlertTM is an investigational device supplied to investigators by Sentire Medical 
Systems, Inc. for the duration of the study 
 
7.3 Acquisition and Accountability  
 
 
 
Anesthetic 
gases 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Perf-ALertTM is an investigational device supplied to investigators by Sentire Medical Systems, Inc. 
for the duration of the study. The device will be stored at the research office located at K802C. The 
device will be examined by the Biomedical Engineering in the Greenberg Operating Rooms and 
will be approved for use in the operating room. 
 
7.10 Duration of Follow Up 
 
Not applicable 
 
 
7.11 Measures to Minimize Bias:  
 
This is a prospective pilot interventional, single-center, single-arm, open-label, phase 1 
investigator-initiated study to determine device ability to detect bowel gas during laparoscopic 
right hemicolectomy with intracorporeal anastomosis using Perf-AlertTM gas detection system 
on 20 subjects into 2 Cohorts. To minimize the selection bias, we will enroll 20 consecutive 
subjects willing to participate in the study. The first 10 subjects will be part of Cohort 1, and the 
following 10 subjects will be part of Cohort 2. 
 
7.12 Study Intervention/Follow-up Compliance 
 
        Subjects will be followed up to 30 ±2 days after surgery 
8. Study Intervention Discontinuation and Participant Discontinuation/Withdrawal 
 
8.1 Discontinuation of Study Intervention 
 
 
Any irregularity or complication during the surgery being performed will be grounds for 
discontinuation of the study intervention and withdrawal of the subject from the study. If the 
laparoscopic surgery has to be converted to an open surgical approach due to medical reasons or 
technical reasons, the study intervention will be discontinued and the subject withdrawn from the 
study. 
  
No data will be collected at the time of study intervention discontinuation, and any data previously 
collected will be excluded from the study analysis and appropriately destroyed. 
8.2 Participant Discontinuation/Withdrawal from the Study 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a participant from the study for the following 
reasons: 
 
• 
If any clinical adverse event (AE), laboratory abnormality, or other medical condition or 
situation occurs such that continued participation in the study would not be in the best 
interest of the participant 
The reason for participant discontinuation or withdrawal from the study will be recorded on 
the on the intraoperative Case Report Form (CRF) and reflected in the WCMC subject 
registration site. Subjects who sign the informed consent form but do not receive the study 
intervention may be replaced.  Subjects who sign the informed consent form, and receive 
the study intervention, and subsequently withdraw, or are withdrawn or discontinued from 
the study will be replaced. 

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8.3 Lost to Follow Up 
The participant’s role in the study is completed at 30 days during which time all data is 
collected.  The subject are coming regularly up to 30 days postop follow up, so we do not 
anticipate lost to follow up.  
 
9. Correlative/Special Studies  
 
Not applicable 
 
9.1 Laboratory Correlative Studies 
 
9.1.1 Title – Laboratory Correlative Study #1 
 
9.1.1.1 Collection of Specimen(s) 
 
9.1.1.2 Handling of Specimen(s) 
 
9.1.1.3 Shipping of Specimen(s) (if multicenter) 
 
9.1.1.4 Site(s) Performing Correlative Study (if multicenter) 
 
9.2 Special Studies 
 
9.2.1 Title – Special Correlative Study #1 
 
9.2.1.1 Assessment 
 
9.2.1.2 Method of Assessment 
 
9.2.1.3 Timing of Assessment 
 
10.  Measurement of Effect 
 
10.1 Response Criteria 
 
 
Measurement of gastrointestinal gases (CH4 and/or H2) when the bowel is in an open 
condition will constitute a positive response for this study. 
 
10.2 Duration of Response  
 
Not applicable 
 
10.3 Progression-Free Survival  
 
Not Applicable 
 
10.4 Other Response Parameters 
 
Not applicable  
 
11. Data Reporting / Regulatory Considerations 
 
11.1 Data Collection 
 
 
The data collection plan for this study is to utilize RedCap and the device data from the gas 
sample analyses.  

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11.1.1 REDCap 
 
REDCap (Research Electronic Data Capture) is a free data management software 
system that is fully supported by the Weill-Cornell Medical Center CTSC.  It is a tool for 
the creation of customized, secure data management systems that include Web-based 
data-entry forms, reporting tools, and a full array of security features including user and 
group based privileges, authentication using institution LDAP system, with a full audit 
trail of data manipulation and export procedures.  REDCap is maintained on CTSC-
owned servers that are backed up nightly and support encrypted (SSL-based) 
connections.  Nationally, the software is developed, enhanced and supported through a 
multi-institutional consortium led by the Vanderbilt University CTSA. 
 
11.2 Regulatory Considerations 
 
11.2.1 Institutional Review Board/Ethics Committee Approval  
 
As required by local regulations, the Investigator will ensure all legal aspects are covered, 
and approval of the appropriate regulatory bodies obtained, before study initiation.  
Before initiation of the study at each study center, the protocol, the ICF, other written material 
given to the patients, and any other relevant study documentation will be submitted to the 
appropriate Ethics Committee. Written approval of the study and all relevant study 
information must be obtained before the study center can be initiated or the IP is released to 
the Investigator. Any necessary extensions or renewals of IRB approval must be obtained 
for changes to the study, such as amendments to the protocol, the ICF, or other study 
documentation. The written approval of the IRB together with the approved ICF must be filed 
in the study files.  
The Investigator will report promptly to the IRB any new information that may adversely affect 
the safety of the patients or the conduct of the study. The Investigator will submit written 
summaries of the study status to the IRB as required. On completion of the study, the IRB 
will be notified that the study has ended.  
 
All agreed protocol amendments will be clearly recorded on a protocol amendment form and 
will be signed and dated by the original protocol approving signatories. All protocol 
amendments will be submitted to the relevant institutional IRB for approval before 
implementation, as required by local regulations. The only exception will be when the 
amendment is necessary to eliminate an immediate hazard to the trial participants. In this 
case, the necessary action will be taken first, with the relevant protocol amendment following 
shortly thereafter.  
Once protocol amendments or consent form modifications are implemented at the lead site, 
Weill Cornell Medicine, updated documents will be provided to participating sites, as 
applicable. Weill Cornell Medicine must approve all consent form changes prior to local IRB 
submission.  
Relevant study documentation will be submitted to the regulatory authorities of the 
participating countries, according to local/national requirements, for review and approval 

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before the beginning of the study. On completion of the study, the regulatory authorities will 
be notified that the study has ended.  
 
11.2.2 Ethical Conduct of the Study  
The Investigators and all parties involved should conduct this study in adherence to the 
ethical principles based on the Declaration of Helsinki, GCP, ICH guidelines and the 
applicable national and local laws and regulatory requirements.  
 
This study will be conducted under a protocol reviewed and approved by the applicable ethics 
committees and investigations will be undertaken by scientifically and medically qualified 
persons, where the benefits of the study are in proportion to the risks. 
 
11.2.3 Informed Consent 
 
The investigator or qualified designee must obtain documented consent according to ICH-
GCP and local regulations, as applicable, from each potential subject or each subject’s 
legally authorized representative prior to participating in the research study. Subjects who 
agree to participate will sign the approved informed consent form and will be provided a copy 
of the signed document.   
 
The initial ICF, any subsequent revised written ICF and any written information provided to 
the subject must approved by IRB prior to use. The ICF will adhere to IRB requirements, 
applicable laws and regulations. 
 
11.2.4 Compliance with Trial Registration and Results Posting Requirements  
 
Under the terms of the Food and Drug Administration Modernization Act (FDAMA) and the 
Food and Drug Administration Amendments Act (FDAAA), the Sponsor-Investigator of the 
trial is solely responsible for determining whether the trial and its results are subject to the 
requirements for submission to http://www.clinicaltrials.gov. Information posted will allow 
subjects to identify potentially appropriate trials for their disease conditions and pursue 
participation by calling a central contact number for further information on appropriate trial 
locations and trial site contact information. 
This study will be registered on clinicaltrials.gov. 
 
11.2.5 Record Retention 
 
Essential documents are those documents that individually and collectively permit evaluation 
of the study and quality of the data produced.  After completion of the study, all documents 
and data relating to the study will be kept in an orderly manner by the Investigator in a secure 
study file.  Essential documents should be retained for 2 years after the final marketing 
approval in an ICH region or for at least 2 years since the discontinuation of clinical 
development of the IP. In addition, all subjects medical records and other source 
documentation will be kept for the maximum time permitted by the hospital, institution, or 
medical practice.   
 
12. Statistical Considerations 
 

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12.1 Study Design/Endpoints 
 
Research question: Can detectable levels of bowel gas methane (CH4) and/or hydrogen 
(H2) be detected in the abdominal cavity when the bowel is open during laparoscopic right 
colectomy with intracorporeal anastomosis using Perf-AlertTM detection system? 
 
Research Hypothesis: H1: Bowel gas, methane (CH4) and/or hydrogen (H2) can be 
detected in the abdominal cavity when the bowel is open during laparoscopic right 
colectomy with intracorporeal anastomosis using the Perf-AlertTM detection system. 
 
Design 
Prospective pilot, single-center, single arm, open label, phase 1 investigator-initiated study 
to determine device ability to detect bowel gas during laparoscopic right colectomy with 
intracorporeal anastomosis using Perf-AlertTM gas detection system on 20 subjects into 2 
Cohorts. 
 
Cohort 1: 10 subjects with measurement of bowel gas at 8 predetermined time  
                 points during right laparoscopic colectomy as follow: 
         
Initiation of surgery/laparoscopy start Insufflation 
2) Abdominal exploration 
3) Completion of colon mobilization  
4) Colon transection  
5) At Colotomy 
6) At Enterotomy 
7) Anastomosis completion 
8) End of surgery- after re-insufflation before closure                            
           Cohort 2:  10 subjects with continuous monitoring of bowel gases through the 
surgery. The level of H2 and CH4 gases will be noted at the 8 predetermined time 
points during the continuous monitoring as well. 
 
Primary end point 
 
Level of Hydrogen (H2) and Methane (CH4) gas measured in ppm or mg/L (parts per 
million or milligrams per liter (mg/L) at 8 time points during the surgery:  
 
Initiation of surgery/laparoscopy start Insufflation 
2) Abdominal exploration 
3) Completion of colon mobilization  
4) Colon transection  
5) At Colotomy 
6) At Enterotomy 
7) Anastomosis completion 
8) End of surgery- after re-insufflation before closure      
 
Secondary endpoint 
 
The response time of the Perf-AlertTM device measured in seconds from obtaining 
the sample (from opening the valve) to first detecting a gas presence at the device 
electronic sensors. 

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Covariates: 
• Demographics 
• Preoperative Diagnosis 
• Existing Medical Conditions  
• Statin drugs in the last 3 months 
• Antibiotics in the last 3 months 
• Intra-abdominal pressure 
• Anesthetic gases 
• Total CO2 volume 
• Intraoperative complications 
 
12.2 Sample Size/Accrual Rate 
 
 
As this is a pilot study, a sample of 20 consecutive subject corresponding to the inclusion and 
exclusion criteria will accrued for the two study cohorts. Cohort 1- 10 subjects and Cohort 2- 10 
subjects.   
 
12.3 Stratification Factors  
 
No stratification factors and no interim analysis will be done. 
 
 12.4 Analysis of Endpoints 
 
12.4.1 Analysis of Primary Endpoints 
 
The gas sample gas composition will be analyzed automatically by the Perf-AlertTM gas detection 
system at the 8 different predetermined time points listed in 12.1. The measurements will be 
recorded in the data collection forms. The maximum value for the particular sample gases – H2 
and CH4, will be recorded and included in the descriptive analysis.  
 
Specifically, the presence of Hydrogen (H2) and Methane (CH4) gas measured in ppm or mg/L 
(parts per million or milligrams per liter (mg/L) at the 8 time points during the surgery will be 
descriptively assessed.  Descriptive statistics (e.g., mean, standard deviation, median, interquartile 
range, frequency and percent) will be calculated for these parameters.  Ninety-five percent 
confidence intervals will be calculated for all parameters of interest to assess the precision of the 
obtained estimates.  No formal hypothesis testing will be performed in the pilot study.  However, 
pairwise time point comparisons will be evaluated by the paired t-test or Wilcoxon signed-rank test, 
as appropriate.  Due to the small sample size in this pilot study, all analyses will be considered 
exploratory and hypothesis-generating with no adjustment for multiple comparisons. All p-values 
will be two-sided with statistical significance evaluated at the 0.05 alpha level. All analyses will be 

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conducted using SPSS for Windows v.25 (IBM Corp. Released 2016. IBM SPSS Statistics for 
Windows, Version 24.0. Armonk, NY: IBM Corp). 
 
12.4.2 Analysis of Secondary Endpoints 
 
Descriptive analysis with measurements of central tendency and dispersion will also be used for 
the secondary endpoints presentation.  
 
12.5 Interim Analysis 
 
            Not Applicable 
 
 12.6 Reporting and Exclusions 
 
12.6.1 Evaluation of Toxicity 
 
Not applicable 
 
12.6.2 Evaluation of Response 
 
                  Not applicable 
 
13. Adverse Event Reporting Requirements  
 
This study will not report specific adverse events, as subjects are undergoing surgery for regular 
care. Furthermore, the device that will be used to collect and analyze the bowel gases from the 
abdominal cavity during surgery is not in direct contact with subjects and does add additional 
physical risk to the subjects. During laparoscopy, the abdominal cavity is being insufflated with 
carbon dioxide (CO2) gas, and a standard pressure between 12mm -15 mm/Hg is maintained 
throughout the surgery in the abdominal cavity for visualization through a CO2 insufflation tubing 
connected with one of the surgical trocars. If the pressure changes, for example, during instrument 
exchange through the laparoscopic port, the CO2 insufflator automatically starts the CO2 flow, so 
the pressure could be maintained between 12mm -15 mm/Hg. When a gas sample for the study is 
collected from the abdominal cavity, the insufflator will simultaneously replace any volume of gas 
removed with new CO2 gas. Therefore, there is no additional risk to the patient due to the gas 
sample collection for research during the surgery. All the intraoperative complications, should there 
be any, would be part of the regular surgical care risk. 
However, all intraoperative complications will be collected as part of the study data collection. Also, 
to ensure safety, the intra-abdominal pressure level will be collected as a data point at the time of 
sample collection as part of the safety monitoring measure.  
  
Any hydrogen (H2) and methane (CH4) detected by the device at time points when clinically, these 
gases are not expected to be found in the abdominal cavity, the operating surgeon will be notified. 
 
 
13.1 Adverse Event Definition 
 
This study does not have specific adverse events. All the interventions are part of regular 
surgical care. The device is not in direct contact with the subject during the surgery. Obtaining 
the gas sample will remove about 500 ml of gas for 90 seconds (1.5 minutes), which is 

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automatically replaced by the CO2 inflow simultaneous with gas sample collection. Therefore, it 
is not anticipated the abdominal pressure to decrease below 12 mm/Hg.   
 
 
13.1.1 Investigational Agent or Device Risks (Expected Adverse Events) 
 
We believe this is a nonsignificant risk device as the device and the expected risk is no 
more than the minimal risk. 
The device: 
• 
Does not come into direct contact with the subject during the surgery 
• 
Does not introduce any energy to the subject 
Further, the device will be labeled appropriately and examined by the biomedical 
engineering at operating rooms at WCMC-NYPH.  
 
13.1.2 Adverse Event Characteristics and Related Attributions 
 
Not Applicable 
 
Specify the adverse event reporting system you will utilize for tracking adverse events 
during the conduct of this study (i.e., NCI Common Terminology Criteria for Adverse Events 
(CTCAE), Vaccine Adverse Event Reporting System (VAER), Division of AIDS (DAIDS) 
Table for Grading the Severity of Adult and Pediatric Adverse Events, Manufacturer and 
User Facility Device Experience Database (MAUDE) and the Special Nutritionals Adverse 
Event Monitoring System).  
 
For example, the following text is text that may be used when utilizing the CTCAE and 
should be changed to reflect the correct AE reporting system.  
 
CTCAE term (AE description) and grade:  The descriptions and grading scales found in 
the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will 
be utilized for AE reporting.  A copy of the CTCAE version 5.0 can be downloaded from the 
CTEP web site (http://ctep.cancer.gov). 
 
• 
Attribution of the AE: 
- Definite – The AE is clearly related to the study treatment. 
- Probable – The AE is likely related to the study treatment. 
- Possible – The AE may be related to the study treatment. 
- Unlikely – The AE is doubtfully related to the study treatment. 
- Unrelated – The AE is clearly NOT related to the study treatment. 
 
 
 
13.1.3 Recording of Adverse Events 
 
While this study will not report adverse events related to the study, the study will collect all the 
intraoperative complications and record them on the data collection forms in the subject's research 
chart. All complications, should there be any, will be recorded in the subject’s medical record as 
they are part of the regular surgical care. 
We do not have expected adverse events related to the Perf-AlertTM device use. However, we are 
reporting unanticipated problems/ unexpected adverse events, which include if the Perf-AlertTM 
device stopping work during surgery or malfunction, and these events will be reported to the IRB, 

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and the device's sponsor Sentire Medical Systems, Inc., USA.  This is described in section 14.1.2 of 
the protocol and is now added to sections 13.1.3 and 13.2.3 of the protocol. In general, we are 
collecting intraoperative and postoperative complications.      
13.1.4 Reporting of AE to WCM IRB 
            This study will not be reporting AE. 
 
13.1.5 Reporting Events to Participants 
 Not Applicable.    
 
13.1.6 Events of Special Interest- 
Not Applicable. 
If applicable, include content in this section otherwise type “Not Applicable.” 
 
13.1.7 Reporting of Pregnancy 
             Not Applicable. 
 
 
13.2 Definition of SAE 
 
SAEs include death, life threatening adverse experiences, prolongation of 
hospitalization, disability or incapacitation, and any other serious events that may 
jeopardize the subject or require medical or surgical intervention to prevent one of the 
outcomes listed in this definition.  
 
13.2.1 Reporting of SAE to IRB 
 
             Not Applicable. 
 
All SAEs occurring on this study will be reported to the IRB according to the IRB policy, 
which can be accessed via the following link:   
http://researchintegrity.weill.cornell.edu/forms_and_policies/forms/Immediate_Reporting_P
olicy.pdf.  
 
13.2.2 Reporting of SAE to FDA [For Protocols Where WCMC is the Sponsor-
Investigator] 
              Not Applicable. 
 
IND application sponsor must report any suspected adverse reaction or adverse 
reaction to study treatment that is both serious and unexpected. Unexpected fatal or 
life-threatening suspected adverse reactions represent especially important safety 
information and must be reported to FDA as soon as possible but no later than 7 
calendar days following the sponsor’s initial receipt of the information. 
i. death, 
ii. a life-threatening adverse event,   
iii. in-patient hospitalization or prolongation of existing hospitalization, 
iv. a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions, or   
v. a congenital anomaly or birth defect 

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Page # 24 
 
 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the patient or research subject and may require 
medical or surgical intervention to prevent one of the outcomes listed as serious 
 
CDER INDs:  
Food and Drug Administration 
Center for Drug Evaluation and Research 
Division of xxxx Products  
5901-B Ammendale Road  
Beltsville, MD 20705-1266  
CDER-only Biologic INDs:  
Food and Drug Administration  
Center for Drug Evaluation and Research  
Therapeutic Biologic Products Document Room  
5901-B Ammendale Road  
Beltsville, MD 20705-1266  
CBER INDs:  
Office of xxxx  
Center for Biologics Evaluation and Research  
Food and Drug Administration  
Suite 200N 1401 Rockville Pike  
Rockville, MD 20852-1448  
 
13.2.3 Reporting of SAE to Sentire Medical Systems, Inc.  
         We are reporting Unanticipated Problems/ Unexpected adverse events which include the Perf-
AlertTM device stop working during surgery, or malfunction, and these events will be reported to the 
IRB and the device sponsor Sentire Medical Systems, Inc.,USA.  This is described in section 14.1.2 
of the protocol, and now added to In general we are collecting intraoperative and postoperative 
complications. 
 
 
13.3 AE/SAE Follow Up 
           Not Applicable. 
 
13.4 Time Period and Frequency for Event Assessment and Follow Up 
 
Not Applicable 
 
 
14. Unanticipated Problems Involving Risks to Subjects or Others 
 
14.1 Definition of Unanticipated Problems Involving Risks to Subjects or Others 
(UPIRTSO) 
 

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In this study, unanticipated adverse device effect will be defined as any unanticipated adverse 
device effect, any serious adverse effect on health or safety, or any life-threatening problem or 
death caused by, or associated with, a device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the investigational plan or application 
(including a supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects (21 CFR 812.3(s)).] 
 
14.1.2 Unanticipated Problem Reporting 
 
The investigator will submit to the sponsor Sentire Medical Systems, Inc. and to the reviewing 
Institutional Review Board (IRB) a report of any unanticipated adverse device effect occurring 
during an investigation as soon as possible, but in no event later than 10 working days after the 
investigator first learns of the effect (21 CFR 812.150(a)(1)), A sponsor who conducts an 
evaluation of an unanticipated adverse device effect under 812.46(b) shall report the results of 
such evaluation to the Food and Drug Administration (FDA) and to all reviewing IRB's and 
participating investigators within 10 working days after the sponsor first receives notice of the 
effect. Thereafter the sponsor shall submit such additional reports concerning the effect as FDA 
requests (21 CFR 812.150(b) (1)).   
 
 
15. Data and Safety Monitoring Plan (DSMP) 
 
 
 
To ensure the safety of clinical research subjects and protect the validity and integrity of 
research data, subjects will be well acquainted with the research study prior to signing research 
informed consent. Further, the subjects will be selected strictly according to the study inclusion and 
exclusion criteria. The electronic data collected as part of this study will be stored in a password-
protected computer, and the paper data will be locked in the locked cabinet in the clinical research 
office located at K802C. We do not anticipate any adverse events related to this study. However, all 
intraoperative surgical complications will be collected as part of this study data. We will report 
unanticipated adverse events to the WCMC IRB and to Sentire Medical Systems. 
 

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7) Llarena, N. C., Shah, A. B., & Milad, M. P. (2015). Bowel injury in gynecologic laparoscopy: 
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11) Künzli, B. M., Spohnholz, J., Braumann, C., Shrikhande, S. V., & Uhl, W. (2018). Clinical 
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12) Wynne, E.K., Azagury, D.E. Novel device to detect enterotomies in real time during 
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