Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function
Phase: NA
Conditions: Gastrointestinal Diseases, Ileus Paralytic, Ileus
Sponsor: Yale University

APPROVED BY THE YALE UNIVERSITY IRB 4/22/2022
 
 
 
 
Myoelectric Activity Following Colorectal 
Surgery and Return of Bowel Function 
 Protocol Number 
2000032548 
 
Protocol Version 
April 21, 2022 
1.4 
 
IDE Number: 
IDE Holder: 
ClinicalTrials.gov Registration: NCT05298774 
 
PRINCIPAL INVESTIGATOR: 
Name  
Ira Leeds, MD 
Department.    Surgery – Division of Colon & Rectal Surgery 
Telephone Number.   475-224-8745 
Email Address         ira.leeds@yale.edu 
 
 
Confidentiality Statement: 
 
 
 
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REVISION HISTORY: 
Revision # 
Version Date 
 
 
 
 
 
 
 
 
 
 
 
 
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Synopsis 
Primary Objective 
To measure myoelectric signals with the G-Tech WPS and determine if a correlation exists 
between signal strength and the rate of gastrointestinal recovery following colorectal surgery. 
Determine the relationship between gastrointestinal myoelectrical signal strength and clinical 
markers of recovery such as passage of flatus/bowel movement, oral tolerance of diet, and 
discharge readiness.  
 
Secondary Objective (if applicable) 
To measure myoelectric signals with the G-Tech WPS and determine if there are differences in 
signal patterns for right colon resections, left colon resections, and rectal resections. 
Study Duration 
12 months for data collection followed by 12 months of data analysis 
Study Design  
This is a single-arm, prospective, non-randomized, feasibility study. 
Number of Study Sites 
1 (Yale New Haven Hospital) 
Study Population 
Patients undergoing elective colorectal surgery 
Number of Participants 
200 
Primary Outcome Variables 
GI functional recovery after surgery as measured by first flatus 
Secondary and Exploratory Outcome Variables (if applicable) 
Rate of inpatient postoperative ileus; rate of readmission for post-discharge ileus; GI functional 
recovery as measured by first bowel movement 
 
 
 
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Abbreviations 
Abbreviation  
Explanation 
AE 
Anticipated adverse event 
CRF 
Case report form 
GI 
gastrointestinal 
SAE 
Serious adverse event 
WPS 
Wireless Patch System 
 
 
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Glossary of Terms 
Glossary 
Explanation 
Erythema 
Reddening of the skin that is a non-specific 
sign of skin irritation, inflammation, or injury.  
It is caused by dilatation of superficial blood 
vessels in the skin 
Myoelectric 
The electric property of a muscle 
Rash 
A reddened inflamed skin usually temporary 
Transcutaneous 
Transdermal; performed through the skin 
 
 
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Table of Contents 
Preface .................................................................................. Error! Bookmark not defined. 
Synopsis ............................................................................................................................... 3 
Primary Objective .............................................................................................................. 3 
Secondary Objective (if applicable) ................................................................................... 3 
Study Duration ................................................................................................................... 3 
Study Design ..................................................................................................................... 3 
Number of Study Sites ....................................................................................................... 3 
Study Population ............................................................................................................... 3 
Number of Participants ...................................................................................................... 3 
Primary Outcome Variables ............................................................................................... 3 
Secondary and Exploratory Outcome Variables (if applicable) .......................................... 3 
Abbreviations ........................................................................................................................ 5 
Glossary of Terms ................................................................................................................. 6 
1 
Introduction .................................................................................................................. 10 
1.1 
Introductory Statement .......................................................................................... 10 
2 
Background .................................................................................................................. 11 
2.1.1 
Device Preclinical Experience ........................................................................ 11 
2.1.2 
Device Clinical Experience ............................................................................. 11 
2.2 
Background/prevalence of research topic ............................................................. 11 
3 
Rationale/Significance.................................................................................................. 13 
3.1 
Problem Statement ............................................................................................... 13 
3.2 
Purpose of Study/Potential Impact ........................................................................ 13 
3.2.1 
Potential Risks ............................................................................................... 13 
3.2.2 
Potential Benefits ........................................................................................... 14 
4 
Study Objectives .......................................................................................................... 15 
4.1 
Hypothesis ............................................................................................................ 15 
4.2 
Primary Objective.................................................................................................. 15 
4.3 
Secondary Objectives (if applicable) ..................................................................... 15 
5 
Study Design ............................................................................................................... 16 
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5.1 
General Design Description .................................................................................. 16 
5.1.1 
Study Date Range and Duration .................................................................... 16 
5.1.2 
Number of Study Sites ................................................................................... 16 
5.2 
Outcome Variables ............................................................................................... 16 
5.2.1 
Primary Outcome Variables ........................................................................... 16 
5.2.2 
Secondary and Exploratory Outcome Variables (if applicable) ....................... 16 
5.3 
Study Population ................................................................................................... 16 
5.3.1 
Number of Participants .................................................................................. 16 
5.3.2 
Eligibility Criteria/Vulnerable Populations ....................................................... 16 
6 
Methods ....................................................................................................................... 18 
6.1 
Treatment – Device ............................................................................................... 18 
6.1.1 
Intended Use for Device  (provide the following information for each device 
being investigated in the study) .................................................................................... 18 
6.1.2 
Device Administration and Schedule .............................................................. 19 
6.1.3 
Method of Assignment/Randomization (if applicable) ..................................... 19 
6.1.4 
Device Calibration .......................................................................................... 21 
6.1.5 
Storage Conditions ........................................................................................ 21 
6.1.6 
Concomitant therapy ...................................................................................... 21 
6.1.7 
Restrictions .................................................................................................... 21 
6.2 
Assessments ........................................................................................................ 21 
6.2.1 
Efficacy .......................................................................................................... 21 
6.2.2 
Safety ............................................................................................................ 22 
6.2.3 
Adverse Events Definition and Reporting ....................................................... 22 
6.2.4 
Pharmacokinetics (if applicable)..................................................................... 24 
6.2.5 
Biomarkers (if applicable) .............................................................................. 24 
6.3 
Study Procedures ................................................................................................. 24 
6.3.1 
Study Schedule .............................................................................................. 25 
6.3.2 
Informed Consent .......................................................................................... 25 
6.3.3 
Screening ...................................................................................................... 25 
6.3.4 
Enrollment ..................................................................................................... 25 
6.3.5 
On Study Visits .............................................................................................. 25 
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6.3.6 
End of Study and Follow-up ........................................................................... 26 
6.3.7 
Removal of subjects ....................................................................................... 26 
6.4 
Statistical Method ................................................................................................. 26 
6.4.1 
Statistical Design ........................................................................................... 26 
6.4.2 
Sample Size Considerations .......................................................................... 26 
6.4.3 
Planned Analysis ........................................................................................... 27 
6.4.4 
Subsets and Covariates ................................................................................. 28 
6.4.5 
Handling of Missing Data ............................................................................... 28 
7 
Trial Administration ...................................................................................................... 29 
7.1 
 Ethical Considerations: Informed Consent/Assent and HIPAA Authorization........ 29 
7.2 
Institutional Review Board (IRB) Review ............................................................... 29 
7.3 
Subject Confidentiality .......................................................................................... 29 
7.4 
Deviations/Unanticipated Problems ...................................................................... 30 
7.5 
Data Collection ..................................................................................................... 30 
7.6 
Data Quality Assurance ........................................................................................ 30 
7.7 
Study Records ...................................................................................................... 30 
7.8 
Access to Source .................................................................................................. 31 
7.9 
Data or Specimen Storage/Security ...................................................................... 31 
7.10 
Retention of Records ............................................................................................ 31 
7.11 
Study Monitoring ................................................................................................... 31 
7.12 
Data Safety Monitoring Plan ................................................................................. 31 
7.13 
Study Modification................................................................................................. 31 
7.14 
Study Discontinuation ........................................................................................... 31 
7.15 
Study Completion ................................................................................................. 31 
7.16 
Conflict of Interest Policy....................................................................................... 31 
7.17 
Funding Source .................................................................................................... 32 
7.18 
Publication Plan .................................................................................................... 32 
8 
Appendices .................................................................................................................. 33 
9 
List of Tables ............................................................................................................... 34 
 
 
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1 Introduction 
1.1 
Introductory Statement 
This document is a protocol for a human research study. The purpose of this protocol is to 
ensure that this study is to be conducted according to ICH GCP guidelines, and according to 
CFR 21 Part 812, other applicable government regulations, and Institutional research 
policies and procedures. 
 
 
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2 Background 
2.1.1 Device Preclinical Experience 
 
G-Tech Medical has developed a noninvasive wireless patch system that measures 
electrical activity from the gastrointestinal smooth muscles on the abdominal surface.   
 
2.1.2 Device Clinical Experience 
 
This technology has been studied as part of several non-significant risk IRB approved 
studies in both adults and pediatric populations to evaluate the patterns of gastrointestinal 
myoelectrical signals following surgery.20–22 The studies demonstrate that signals measured 
by the G-Tech Wireless patches correlate with clinical markers of postoperative recovery 
such as time to feeding and time to flatus following pancreaticoduodenectomy and general 
abdominal surgeries respectively. The study in patients undergoing 
pancreaticoduodenectomy procedures was conducted in collaboration with researchers at 
Stanford University.20 The study demonstrated that measurement of gastric activity 
beginning immediately after pancreaticoduodenectomy with the G-Tech Wireless Patch 
System, based on the measured spectral peak near 3 cpm, could distinguish patients with 
shorter or longer times to diet readiness. The study demonstrated the potential utility of the 
G-Tech Patch System in providing objective data to identify patients who are progressing as 
well as, or better than expected, and those who are at risk for delayed gastric emptying. In 
another open, prospective study, researchers examined the use of the G-Tech Wireless 
Patch System in predicting time to first flatus by looking at colonic myoelectrical activity 
following general abdominal surgeries.21 Patients with early flatus had stronger early colonic 
activity than patients with late flatus. At 36 h post-surgery, a linear fit of time to flatus vs 
cumulative colonic myoelectrical activity predicted first flatus as much as 5 days (± 22 h) 
before occurrence.   
 
 
2.2 
Background/prevalence of research topic 
 
Gastrointestinal recovery after any visceral surgery is a complex dynamic process with 
multiple factors ranging from complexity of the surgery, degree of bowel handling and 
preoperative comorbidities affecting whether the recovery happens over few days, or is a 
slow prolonged affair lasting weeks.1 Delays in the gastrointestinal recovery process or ileus 
is accompanied by distention of the abdomen, pain, nausea, vomiting and the inability to 
tolerate oral feeding.2,3 Interventions to alleviate the ileus/distention include insertion or 
reinsertion of a nasogastric tube, instating nil per os and, if necessitated, parenteral 
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nutrition.4  All of these factors contribute not only to patient discomfort, but extend length of 
stay (LOS), increase hospital resource utilization and thereby add to overall costs.5–7   
 
Clinically, the markers of gastrointestinal recovery are noted by passage of flatus, defecation 
and the ability to tolerate solid food without significant nausea and vomiting.8 Passage of 
stool or flatus - considered a surrogate for intestinal and anastomotic continuity - is often 
used as the trigger to start stepwise dietary orders with the patient’s ability to tolerate each 
step marking their readiness for the subsequent meal.  Fast-track and Enhanced Recovery 
After Surgery (ERAS) programs that promote early feeding in advance of these clinical 
markers, along with opioid sparing techniques and use of minimally invasive procedures 
have been shown to be safe and beneficial for many patients by demonstrating earlier 
recovery and shorter length of stay.9–11 However, it has also been shown that, for as many 
as 25% of cases, the strategy does not work as noted earlier, with the need for reinsertion of 
the nasogastric tube and reinstating nil per os status. In a recent study of 513 consecutive 
colorectal patients who were on an ERAS protocol, 128 patients (24.7%) needed 
postoperative reinsertion of nasogastric tube at the 3.9±2.9 postoperative day.9 This 
suggests that, while early postoperative feeding is beneficial to patients in whom recovery is 
on track, it does not work in cases where patients are not ready for it.   
 
At present, there is no reliable measurement that can predict gastrointestinal recovery/diet 
readiness for patients in advance of these clinical markers that may allow for interventions or 
fast-track programs to facilitate timely recovery. Auscultation for return of bowel sounds, long 
part of the standard of care, is controversial in its usefulness to indicate recovery. Bowel 
sounds have shown to have poor correlation with flatus/defecation and have proved 
unsuccessful in guiding diet interventions.12,13  
 
Smooth muscle electrical activity on the other hand is directly related to gastrointestinal 
function and motility. Researchers have previously shown a 1:1 correlation between 
electrical and mechanical (contractile) events in the colon with internally placed electrode-
strain gauge force transducers.14–16 Electrical activity in the colon has been reported across 
a wide range of frequencies ranging from 0 to 40 cycles per min (cpm)).17 Condon et. al have 
documented the progressive return of colonic electrical related to resolution of postoperative 
ileus and clinical recovery following surgery.18,19 These measurements have been performed 
using electrodes placed internally during surgery, a major impediment towards broader use 
of such technology.   
 
 
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3 Rationale/Significance 
3.1 
Problem Statement 
GI functional recovery after surgery is unpredictable and contributes to increased length of 
stay and postoperative readmissions for ileus. 
 
3.2 
Purpose of Study/Potential Impact 
The purpose of the Phase 1 study is to determine if the myoelectrical measurements made 
by the G-Tech Wireless Patch System correlate with clinical markers of postoperative 
recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge 
readiness. Subsequently the data will be studied to establish which information in the signals 
is important in determining when to feed patients and possibly discharge them. 
 
These pilot prospective, open clinical studies suggests that myoelectrical activity, measured 
on the abdominal surface with a noninvasive wireless patch system, carries predictive value 
in determining time to feeding and time to flatus following open abdominal surgery. Having 
such information in advance of clinical measures could facilitate timely interventions, be it 
early feeding or delaying feeding as dictated by the patient’s unique recovery profile. The G-
Tech Wireless Patch System would provide a unique insight into the process allowing for a 
tailored protocol that could improve patient satisfaction and optimize recovery. The system 
could also enable feedback on the impact to the overall gastrointestinal myoelectrical activity 
of medications, particularly opioids, used for pain management that are known to inhibit 
gastrointestinal function by disrupting the normal recovery patterns of colonic motility.23–25 
While it remains to be seen, in addition to predicting time to flatus/bowel movement early on, 
the ability to continue monitoring the patient may allow one to predict onset of secondary 
complications, such as wound infections or anastomotic leaks, that are associated with ileus.  
Although not part of this protocol, given the wireless noninvasive nature of the system the 
patients could be discharged home with the patches, whereby they would serve as a remote 
monitoring tool. This could be particularly useful in cases where the patients may have been 
discharged early and may be at a high risk for readmission. The system would then send 
updates/alerts to the care team for management and potentially avoid preventable 
readmissions. 
 
 
3.2.1 Potential Risks 
 
The risks associated with the G-Tech Patch System are related with the use of the G-
Tech Patch (electrical risks, skin allergy or chemical) and the export of the data 
(anonymized data sent to G tech).  
 
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3.2.2 Potential Benefits 
There are no direct benefits to participants. The information gained from their experience 
with the device may decrease healthcare utilization needs of future patients. 
 
 
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4 Study Objectives 
4.1 
Hypothesis 
 
Myoelectric signaling patterns of the abdominal cavity after surgery will correlate with first 
flatus. 
 
4.2 
Primary Objective 
To measure myoelectric signals with the G-Tech WPS and determine if a correlation exists 
between signal strength and the rate of gastrointestinal recovery following colorectal surgery. 
Determine the relationship between gastrointestinal myoelectrical signal strength and clinical 
markers of recovery such as passage of flatus/bowel movement, oral tolerance of diet, and 
discharge readiness.  
 
4.3 
Secondary Objectives (if applicable) 
To measure myoelectric signals with the G-Tech WPS and determine if there are differences 
in signal patterns for right colon resections, left colon resections, and rectal resections. 
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5 Study Design 
5.1 
General Design Description 
 
Single-arm, nonrandomized feasibility study to evaluate the ability to correlate myoelectric 
signals of the abdomen after surgery to GI functional recovery. 
 
5.1.1 Study Date Range and Duration 
Data Collection: June 1, 2022 to May 30, 2023  
Data Analysis: June 1, 2022 to May 30, 2024 (data analysis intentionally overlaps with 
collection as it is done algorithmically in near real-time) 
 
5.1.2 Number of Study Sites 
Single site. Yale New Haven Hospital 
 
5.2 
Outcome Variables 
5.2.1 Primary Outcome Variables 
GI functional recovery after surgery as measured by first flatus 
5.2.2 Secondary and Exploratory Outcome Variables (if applicable) 
• 
Rate of inpatient postoperative ileus 
• 
Rate of readmission for post-discharge ileus 
• 
GI functional recovery as measured by first bowel movement 
 
5.3 
Study Population 
 
Patients undergoing resection of portions of the colon and rectum with anastomosis. 
 
 
5.3.1 Number of Participants 
200 
5.3.2 Eligibility Criteria/Vulnerable Populations 
 
Any subject who undergoes an open or laparoscopic colon or rectum resection surgery 
Inclusion Criteria: 
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1. Willing and able to provide informed consent 
2. Eighteen (18) years of age or older  
3. Subject is willing and able to follow all study requirements 
4. Subject has undergone or will undergo a laparoscopic or open colorectal surgery with 
resection and anastomosis 
Exclusion Criteria: 
1. Subject is pregnant or suspects pregnancy. 
2. Known allergy to medical grade adhesive. 
 
 
 
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6 Methods 
6.1 
Treatment – Device  
6.1.1 Intended Use for Device  (provide the following information for each device 
being investigated in the study) 
The G-Tech WIRELESS Patch System is a non-invasive wireless gastrointestinal 
monitoring system. The platform has received approval via the 510(k) process 
supervised by the U.S. Food and Drug Administration. The system consists of G-Tech 
Patches, the G-Tech Patch Monitor, an iOS application, and data analysis algorithms.  
 
 
 
 
 
 
The G-Tech Patch acquires and transmits electrical signals from the gastrointestinal tract 
via Bluetooth to the G-Tech Patch Monitor.  The G-Tech Patch Monitor receives the raw 
data and periodically uploads it to a secure cloud server. Additionally, the Patch Monitor 
has a patient interface to allow the patient to manual enter events such as meals, bowel 
movements, pain or the taking of medications.  
 
G Tech Patches
G-Tech App 
Cloud Server 
Data analysis 
Figure 1 The G-Tech Wireless Patch System (WPS) 
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Data analysis algorithms process the uploaded data to measure and report myoelectrical 
motor activity levels for the stomach and intestines. These measurements will be made 
available to the study investigators to identify correlations between return and patterns of 
myoelectrical activity with time to feeding and discharge. Patients do not have 
independent access to either the raw data or calculated results except as shared with 
them by their physician. 
 
 
 
 
6.1.2 Device Administration and Schedule 
The G-Tech patches will be placed on patient post-operatively following surgery either in the 
Post Anesthesia Care Unit (PACU) or in their hospital room, within 4 hours of being 
transported out of the operating room. Research staff will activate three (3) G-Tech patches 
and pair them with the G-Tech App on an iPhone 7 (provided). The patches will be 
periodically sending the data to the paired iPhone 7, which will remain by the patient’s 
bedside until discharge. The G-Tech Patches are intended to run continuously for up to 6 
days and have been shown to run continuously for up to 14 days in pilot testing. The patient, 
caregiver or staff member shall record activities such as first solid meal, first flatus, first 
bowel movement on the easy-to-use iPhone app during the patients stay. The inpatient 
physician-led team will also remind the patient to enter information into the app daily. The 
recorded events and gut myoelectrical activity are transferred wirelessly via the paired 
iPhone to the cloud. The Patches shall be replaced as needed. All patches are removed 
before patient is discharged. 
 
Skin Preparation  
 
Figure 2 The G-Tech Patch and G-Tech Patch Monitor App 
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Locate the approximate patch locations on the abdomen according to Figure 2. Patch 
locations can be varied depending upon the surgery incisions. Patches are not sterile and 
should be placed at least an inch distance from any incision. Clip abdominal hair as needed 
in the patch location if not clipped prior to surgery. Clean the skin thoroughly using alcohol 
pads and let dry before applying the patches.  
 
G-Tech Patch Placement Procedure 
Patches should be placed on the patient as soon as possible and in no case later than 4 
hours after surgery. Staff member shall activate and apply G-Tech Patches (recommended 
number of patches is 3) to the patient in the locations shown in Figure 3. The G-Tech 
Patches are intended to run continuously for up to 6 days. Patches shall be replaced as 
needed. Patches are removed before patient is discharged. 
 
Study subject instructions for reporting events such as diet and physical symptoms 
The patient, caregiver or staff member shall record activities such as first solid meal, first 
flatus, first bowel movement on an easy-to-use iPhone app during the patient’s stay. The 
recorded events and gut myoelectrical activity are transferred wirelessly via the paired 
iPhone to the cloud. If they forget to log an event, they may change the time to backlog.  
 
 
   
 
 
 
 
 
L
R
Approximate patch 
l
ti
Figure 3 G-Tech Patch abdominal locations 
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6.1.3 Method of Assignment/Randomization (if applicable) 
n/a 
 
6.1.4 Device Calibration  
n/a 
6.1.5 Storage Conditions 
Each device comes sealed from the manufacturer and is designed to be used and re-
processed. Sealed patches will be kept in a temperature-controlled (10-40 degrees Celsius), 
locked research cabinet in the PI’s divisional offices. Used patches will be placed in a sealed 
plastic bag and returned to the manufacturer per their re-processing instructions. The re-
processing itself has been reviewed and approved by the U.S. FDA under the 
manufacturer’s 510(k) approval. The investigator and research team have no role in re-
processing other than returning opened and activated patches back to the manufacturer 
through regular U.S. mail. 
6.1.6 Concomitant therapy 
No restrictions 
 
6.1.7 Restrictions 
No tub bathing while device is in use (showers ok). 
The G-Tech Patch has an IP23 rating which means it is protected from touch by fingers 
and objects greater than 12 millimeters. The rating also indicates that it is protected 
from water spray less than 60 degrees from vertical. It is advised to take short 5-minute 
showers with back facing shower head. Tub bathing or any type of bathing where the 
device could be submersed in water or exposed to moisture or water or soaked with 
water (sponge bath or bed bath) during washing is not permitted.   
 
 
6.2 
Assessments 
6.2.1 Efficacy 
n/a 
Figure 4 Logging events in the G-Tech App 
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6.2.2 Safety 
The investigator will collect data and report the treatment or device related events that occur 
during the Study.  Anticipated adverse events in this study are adverse events that are not 
considered serious and have previously been identified in the nature, severity, or the degree 
of incidence.  An anticipated adverse event is synonymous with adverse event.  These are 
not serious, and they are possibly, probably, or definitely related to the device. 
Assessment for unanticipated adverse device effects  and serious adverse events will take 
place at each treatment visit prior to, during, and after each treatment, and at each follow-up 
visit. 
 
 
6.2.3 Adverse Events Definition and Reporting 
Adverse Event Reporting Requirements 
Adverse event data will be collected on the adverse event case report form for the study.  
Adverse events are not required to be reported immediately to G-Tech Medical.  Adverse 
events are to be collected, and data is to be provided on the case report form. 
 
Assessing for Adverse Events 
Assessment for adverse events will take place during the wearing of the G-Tech Patch device.  
List of Anticipated adverse events related to the G-Tech Patch: 
 
• 
Erythema 
• 
Pruritis (itching) 
• 
Ecchymosis (bruising) 
• 
Rash 
• 
Discomfort   
 
Unanticipated Adverse Device Effect 
Unanticipated Adverse Device Effect Definition (UADEs) 
An unanticipated adverse device effect (UADE) is defined as “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 the 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”.  
 
UADE Reporting Requirements (21 CFR 812.46 & 812.150) 
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UADEs must be reported by the clinical investigator to the reviewing IRB and G-Tech 
Medical, as described below:1 
• 
An investigator shall notify G-Tech Medical immediately but no later 
than within 24 hours first notification of a UADE. 
• 
G-Tech Medical, with the assistance of the study site, must 
immediately conduct an evaluation of a UADE. 
• 
G-Tech Medical must report the results of the evaluation to the 
reviewing IRB, and participating investigator within 10 working days 
after G-Tech Medical first receives notice of the effect (§§ 812.46(b), 
812.150(b)(1)).  
• 
Investigators are required to submit a report of a UADE to the 
reviewing IRB and G-Tech Medical as soon as possible, but in no 
event later than 10 working days after the investigator first learns of the 
event (§ 812.150(a)(1)).  
 
Assessing for UADEs 
Assessment for UADEs will take place at each treatment visit prior to, during, and after each 
treatment, and at each follow-up visit. 
 
Serious Adverse Events (SAEs) 
Serious Adverse Event Definition 
Serious adverse events are anticipated and serious in nature.  Serious adverse event is 
defined as follows: 
 
Results in death, 
 
Is life threatening, 
 
Requires inpatient hospitalization or prolongation of existing hospitalization, 
 
Results in persistent or significant disability/incapacity, or 
 
Is a congenital anomaly / birth defect 
 
SAE Reporting Requirements 
An investigator shall notify G-Tech Medical immediately but no later than within 24 hours of a 
SAE. G-Tech Medical shall conduct an immediate investigation of any SAE.  An investigator 
shall submit to G-Tech Medical and to the reviewing IRB a report of any SAE occurring 
during an investigation as soon as possible, but in no event later than 10 working days after 
the investigator learns of the effect.   
 
Assessing for SAEs 
Assessment for SAEs will take place at each treatment visit prior to, during, and after each 
treatment, and at each follow-up visit. 
 
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Categories of Device Relationship 
The following categories will be used to document adverse events and serious adverse events 
relatedness to the investigational device or treatment, and what is reportable to G-Tech 
Medical. 
ATTRIBUTION 
DEFINITION 
DATA 
COLLECTED 
Unrelated 
The adverse event is clearly not related to 
the device or procedure(s). This is NOT 
collected. 
NO 
Possibly  
Related 
The adverse event may be related to the 
device or treatment(s).  This will be collected 
according to the reporting requirements in 
this protocol. 
YES 
Probably 
Related 
The adverse event is likely related to the 
device or treatment (s). This will be collected 
according to the reporting requirements in 
this protocol. 
YES 
Definitely 
Related 
The adverse event is clearly related to the 
device or treatment (s).  This will be 
collected according to the reporting 
requirements in this protocol. 
YES 
Unknown 
The investigator cannot determine the 
relatedness of the adverse event to the 
device. This will be collected according to 
the reporting requirements in this protocol. 
YES 
 
 
 
6.2.4 Pharmacokinetics (if applicable) 
n/a 
6.2.5 Biomarkers (if applicable) 
n/a 
6.3 
Study Procedures 
 
 
 
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If a patient is unreachable by telephone, an alternative recruitment strategy will be used 
where they are approached in person in the preoperative readiness area prior to proceeding 
to the OR. The same scripted paragraph will be read, and they will be offered the opportunity 
to e-consent using the REDCap form provided on a study-supplied, secured iPad. 
 
6.3.1 Study Schedule 
Preoperative period – Study Consent 
Within 4 hours of existing operating room – Patches placed by study staff 
Daily postoperative visit – reminder to enter information to the supplied iPhone 
Day of discharge – Removal of patches by study staff 
 
6.3.2 Informed Consent 
Informed consent will be obtained using the documents reviewed and approved by the Yale 
IRB of the participant or their legally authorized representative. The process will be managed 
with the patient by a non-clinician member of the study team to avoid undue influence or 
coercion. The patient will be able to review the electronic informed consent document in the 
place and time of their own choosing. 
 
6.3.3 Screening 
Patients will be treated according to standard of care. The study team will perform a daily 
review of postings by colorectal surgeons included on this proposal (Longo, Reddy, Pantel, 
Mongiu, and Leeds). Eligibility criteria used to review these postings will be accessible in the 
patient’s electronic medical record.  
 
6.3.4 Enrollment  
Patients will be recruited by a non-clinician member of the study team by telephone. This 
device study represents low-risk. Informed consent will be obtained preoperatively by 
telephone. Patients will verbally hear a scripted consent by a member of the study team and 
be asked for their assent. If they agree, they will be electronically emailed a unique single-
use REDCap link to complete the e-consent which will include the scripted paragraph heard 
earlier as well as all necessary consent components.   
6.3.5 On Study Visits 
Electronic informed consent – Average read time 10 minutes. Patients will be consented in 
electronic form and have up to 3 weeks to review document if desired and consent. 
Postoperative patch placement – 5 minutes 
Daily visit – 5 minutes 
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Day of discharge patch removal – 5 minutes 
 
6.3.6 End of Study and Follow-up 
End of study will be discharge of the patient and removal of patches, or early withdrawal by 
patient or clinician request.  
30-days after discharge each patient’s electronic medical record will be reviewed for 
documentation of primary and secondary end points and entered into a REDCap database. 
6.3.7 Removal of subjects 
During the study, it is possible that study subjects may be withdrawn from the study.  If a 
withdrawal is related to the study procedure causing an adverse event, a Study Termination 
Form will be completed for each subject withdrawal.  Factors that may lead to a withdrawal 
from the study may include, but are not limited to the following: 
 
Subject Withdrawal 
At any time, a study subject may voluntarily withdraw from the study.  This withdrawal will not 
affect their future medical treatment or benefits.   
 
Physician Decision/Medical Decision 
Should a physician decide that the requirements of the protocol are detrimental to the health 
and welfare of the study subject, the study subject may be withdrawn from this study.  The 
reason for the decision will be documented in the case report form. If the subject is found to 
not be wearing the device in its proscribed fashion and the data cannot be interpreted in its 
intended form, a member of the study team will complete a Study Termination Form and 
review with the prinicipal investigator upon withdrawal. 
 
6.4 
Statistical Method 
6.4.1 Statistical Design 
 
 
 
 
6.4.2 Sample Size Considerations 
This study aims to enroll 200 subjects. In a similar study1 where subjects were enrolled and 
monitored after pancreaticoduodenectomy surgery, it was observed that 75 subjects 
 
1 Dua, M.M., Navalgund, A., Axelrod, S., Axelrod, L., Worth, P.J., Norton, J.A., Poultsides, G.A., 
Triadafilopoulos, G. and Visser, B.C., 2018. Monitoring gastric myoelectric activity after 
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provided the required power to detect significant difference between early and late oral 
tolerance diet groups. The increase sample size shown here is to observe myoelectric 
differences between right colon, left colon, and rectum resections. 
 
6.4.3 Planned Analysis 
6.4.3.1 Primary Analyses 
The primary endpoint is to determine if there is a correlation between the measured motor 
activity metrics of the various GI organs with measures of recovery, and to mathematically 
characterize the correlation in a manner that leads to predictive ability.  The study is 
retrospective without intention to treat.  Data analysis is performed by the staff of G-Tech 
Medical located in Mountain View, CA using proprietary software developed specifically for 
this purpose.  Data is accessed on a secure cloud server to which it was uploaded by the 
mobile app connected to the patches. 
Data analysis consists of extracting the myoelectric motor activity measured by the patches 
in ten-minute time segments and assigning them to an organ or organs.  The motor activity 
at any one time (instantaneous) and the cumulative activity up to that point in time will be 
examined for correlation to parameters associated with recovery rate such as time to first 
flatus, time to first solid meal, time to discharge, etc.  This will be done across all time points 
to find the earliest time that offers predictive value.  The specific final analysis approach 
taken will depend on the findings of this pilot study. 
In the study2 with colonic myoelectric activity measurements after open abdominal surgery 
an inverse correlation was found between cumulative colon signal strength and time to first 
flatus which was approximately linear and was best characterized by the root mean square 
(RMS) deviation of the residuals from a linear fit, in units of hours.  The optimal time for this 
analysis was found to be at 36 hours after surgery. 
 
Similarly in the study1 with patients undergoing pancreaticoduodenectomy procedure, a 
correlation was found between cumulative signal strength of the stomach and time to first full 
meal that was also inverse but not well represented by a linear or other fit.  In this case the 
analysis involved assigning patients to one of two groups, early and late feeders.  The 
stomach activity data were then tested for predictive value against these groups.  Patients 
with stronger signals were more likely to be in the early feeding group and vice versa.  A 
statistical analysis was performed using a receiver-operator characteristic approach that led 
 
pancreaticoduodenectomy for diet “readiness”. American Journal of Physiology-Gastrointestinal and Liver 
Physiology, 315(5), pp.G743-G751. 
 
2 Navalgund, A., Axelrod, S., Axelrod, L., Singhal, S., Tran, K., Legha, P. and Triadafilopoulos, G., 2019. 
Colon myoelectric activity measured after open abdominal surgery with a noninvasive wireless patch system 
predicts time to first flatus. Journal of Gastrointestinal Surgery, 23(5), pp.982-989. 
 
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to specificity and sensitivity values as a function of time after surgery, which allowed 
determination of the optimal time, which was again at approximately 36 hours. 
 
6.4.3.2 Secondary Objectives Analyses 
In addition to the analysis above, electronic medical record review will allow for the rate of 
ileus, readmission, and first bowel movement to be further correlated with the processed 
myoelectric signal. 
6.4.3.3 Safety 
Anticipated and unanticipated adverse device events will be monitor through hospitalization and 
30-days after surgery based on the definitions above. Descriptive statistics will be reviewed with 
the study team and the manufacturer. 
6.4.3.4 Analysis of Subject Characteristics 
Descriptive statistics will be reported for age, sex, race, indication for surgery, type of 
anatomic resection, ostomy present preoperatively, ostomy present postoperatively,  
duration of operation, operative approach (open, laparoscopic, robotic). 
6.4.3.5 Interim Analysis (if applicable) 
n/a 
6.4.3.6 Health economic evaluation 
n/a 
6.4.3.7 Other 
n/a 
6.4.4 Subsets and Covariates 
See subject characteristics above 6.4.3.4. 
6.4.5 Handling of Missing Data 
Missing data will be first attempted to be mitigated by soliciting patient recall through an 
additional telephone encounter. If information remains missing, this patient will be dropped 
from further analysis if the missing data is necessary. 
 
 
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7  Trial Administration 
7.1 
 Ethical Considerations: Informed Consent/Assent and HIPAA Authorization 
 
Declaration of Helsinki 
Compliance with the Declaration of Helsinki provides public assurance that the rights, safety, 
and well-being of trial subjects are protected, and that the clinical trial data are credible.   
 
7.2 
Institutional Review Board (IRB) Review 
The protocol will be submitted to the IRB for review and approval. Approval of the protocol 
must be obtained before initiating any research activity. Any change to the protocol or study 
team will require an approved IRB amendment before implementation.  The IRB will 
determine whether informed consent and HIPAA authorization are required.   
The IRB will conduct continuing review at intervals appropriate to the degree of risk, but not 
less than once per year. 
A study closure report will be submitted to the IRB after all research activities have been 
completed.    
Other study events (e.g. data breaches, protocol deviations) will be submitted per Yale’s 
institution's  IRB's policies. 
 
7.3 
Subject Confidentiality 
 
Subject confidentiality is held in strict trust by the research team.  Subject medical record 
review will be limited to the just the elements needed to complete the study.  Only authorized 
HIPAA and GCP trained study team members will be allowed to extract research data from 
medical records and enter it into REDCap. No direct subject identifiers will be entered into 
the data provided to the manufacturer. 
Each subject will be assigned a unique study number. A master list linking the unique study 
number to the human subject will be maintained in a secured Yale Box.com file held by the 
PI. Each subject will be assigned an alphanumeric character consisting of 4 alpha 
characters, followed by 3 decimal digits. The 4 alpha characters shall represent the 
site/institution name. The 3 decimal digits shall start with the number (001) followed by 
consecutive numbering of all consented study subjects.  For example, Yale’s third subject 
consented and enrolled will be numbered:  
Y A L E – 0 0 3.  
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All subjects enrolled will be numbered consecutively even if they are a screen failure.  The 
subjects will be identified as consented, enrolled, and receiving the investigational device in 
the screening and device accountability log on Yale’s REDCap,  
 
7.4 
Deviations/Unanticipated Problems 
Protocol deviations are not permitted in this study.  A protocol deviation is only acceptable if 
it is to protect the welfare and safety of a subject.  A Protocol Deviation Case Report Form 
will be required to be completed if a protocol deviation occurs.   
 
7.5 
Data Collection 
Screening, Demographics, and Eligibility Case Report REDCap Form 
The Principal Investigator will ensure collection of screening and eligibility data that allows 
for documentation to show the study subject meets all eligibility criteria and has been 
properly selected to participate in the study. This can be achieved through a case report 
form submitted via REDCap. Additionally, demographics and clinical history shall be used to 
further document the subject’s appropriateness for this study and collect the characteristics 
of the subject that contribute to the analysis of the statistical characteristics of the study 
population.  
 
Recording Procedure and Clinical Markers Case Report Form 
The Principal Investigator will ensure collection of the time of device placement, and the device 
serial number.  The information shall be updated if a new device is used.  The Principal 
Investigator will ensure collection of clinical markers of recovery which at a minimum include 
time of first flatus, time of first bowel movement, time of first solid meal and time of discharge. 
These minimum set of inputs should be entered in the G-Tech Patch Monitor App. 
 
7.6 
Data Quality Assurance 
Data will be stored and collected into two centrally cloud-based locations. Myoelectric signal 
data and clinical markers of recovery will be fed into G-Tech’s centrally managed, 
deidentified cloud server via the G-Tech Patch Monitor App. Eligibilty criteria, clinical history, 
and 30-day recovery will be abstracted by a member of the study team, input into REDCap 
with a study tablet, and stored locally at the Yale REDCap instance. 
 
7.7 
Study Records 
 
Screening, Eligibility, and Clinical Case Report Form (REDCap) 
Informed e-Consent Log (REDCap) 
Recording Procedure and Clinical Marker Case Report Form (REDCap) 
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Protocol Deviation Form (REDCap) 
Study Exit Form (REDCap) 
Subject ID Log (PI Yale Box.com) 
 
7.8 
Access to Source 
Myoelectric signal analysis and G-Tech App clinical marker information will be provided back 
to the PI courtesy of G-Tech. The PI will use the unique identifier to re-link these results to 
the demographic and clinical characteristic data collected locally and held within REDCap. 
 
7.9 
Data or Specimen Storage/Security 
All data will be collected in REDCap. Archival logs and analytic datasets derived from the 
REDCap data will be maintained on a HIPAA-compliant partition of Yale Box.com in a file 
owned by the PI. 
 
7.10 Retention of Records 
Records will be retained up to 3 years to allow for subanalysis as needed. 
7.11 Study Monitoring 
Study monitoring will be performed by the internal study team with triggers for manufacturer 
notification and IRB notification as described above in study safety sections. 
 
7.12 Data Safety Monitoring Plan 
The risk level of this study is deemed to be low. The device has already received US FDA 
510(k) approval and the information collected from patients is not provided back to the 
treating clinical team.  
 
7.13 Study Modification 
Protocol deviations are not permitted. All changes to the study protocol will be submitted as 
an amendment for review to the Yale IRB. 
 
7.14 Study Discontinuation 
Study will be discontinued when meeting its enrollment goal or deemed to be unsafe to 
proceed after any IRB- or manufacturer-reviewed patient safety event.  
7.15 Study Completion 
The study is intended to be completed by May 30, 2024. Study completion will be officially 
recognized with termination documents submitted to the Yale IRB.  
7.16 Conflict of Interest Policy 
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No member of the internal study team maintains a conflicted relationship with the device 
manufacturer. Any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. 
Furthermore, persons who have a perceived conflict of interest will be required to have such 
conflicts managed in a way that is appropriate to their participation in the trial. The study 
leadership in conjunction with the appropriate conflict of interest review committee has 
established policies and procedures for all study group members to disclose all conflicts of 
interest and will establish a mechanism for the management of all reported dualities of 
interest. 
 All investigators will follow the applicable conflict of interest policies. 
7.17 Funding Source 
All expenses are supported by internal departmental research startup funds. There is no 
external source of funding  
7.18 Publication Plan 
Results of this study will be disseminated via peer-reviewed conference abstracts and 
scientific journals. 
 
 
 
 
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8 Appendices 
Appendix # 
Title 
1 
Informed e-Consent 
2  
Screening, Eligibility, and Demographics Form 
3 
Recording Procedure and Clinical Markers Case Report Form 
4 
Protocol Deviation Form 
5 
Exit Form 
6 
Adverse Event Form 
 
 
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9 List of Tables 
10 References 
1. 
Luckey, A., Livingston, E. & Taché, Y. Mechanisms and treatment of postoperative 
ileus. Arch. Surg. 138, 206–214 (2003). 
2. 
Mattei, P. & Rombeau, J. L. Review of the pathophysiology and management of 
postoperative ileus. World J. Surg. 30, 1382–1391 (2006). 
3. 
Kehlet, H. & Holte, K. Review of postoperative ileus. Am. J. Surg. 182, 3S-10S (2001). 
4. 
Ahmed, J., Mehmood, S. & MacFie, J. Postoperative Ileus in Elective Colorectal 
Surgery: Management Strategies. in Contemporary Issues in Colorectal Surgical 
Practice 35–54 (2012). doi:10.5772/32456 
5. 
Goldstein, J. L. et al. Inpatient Economic Burden of Postoperative Ileus Associated 
with Abdominal Surgery in the United States. P&T 32, 82–90 (2007). 
6. 
Iyer, S., Saunders, W. B. & Stemkowski, S. Economic burden of postoperative ileus 
associated with colectomy in the United States. J. Manag. Care Pharm. 15, 485–494 
(2009). 
7. 
Flynn, D. N., Speck, R. M., Mahmoud, N. N., David, G. & Fleisher, L. A. The impact of 
complications following open colectomy on hospital finances: a retrospective cohort 
study. Perioper. Med. 3, 1 (2014). 
8. 
Van Bree, S. H. W. et al. Identification of clinical outcome measures for recovery of 
gastrointestinal motility in postoperative ileus. Ann. Surg. 259, 708–714 (2014). 
9. 
Grass, F. et al. Postoperative ileus in an enhanced recovery pathway—a retrospective 
cohort study. Int. J. Colorectal Dis. 32, 675–681 (2017). 
10. 
Delaney, C. P., Kiran, R. P., Senagore, A. J., Brady, K. & Fazio, V. W. Case-Matched 
Comparison of Clinical and Financial Outcome after Laparoscopic or Open Colorectal 
Surgery. Ann. Surg. 238, 67–72 (2003). 
11. 
Shapiro, S. B. et al. Implementation of an Enhanced Recovery After Surgery Program 
for Colorectal Surgery at a Community Teaching Hospital. Wmj 22–27 (2017). 
12. 
Read, T. E., Brozovich, M., Andujar, J. E., Ricciardi, R. & Caushaj, P. F. Bowel 
Sounds Are Not Associated with Flatus, Bowel Movement, or Tolerance of Oral Intake 
in Patients after Major Abdominal Surgery. Dis. Colon Rectum 60, 608–613 (2017). 
13. 
Waldhausen, J. H., Shaffrey, M. E., Skenderis, B. S., Jones, R. S. & Schirmer, B. D. 
Gastrointestinal myoelectric and clinical patterns of recovery after laparotomy. Ann. 
Surg. 211, 777–784 (1990). 
14. 
Sarna, S. K. Physiology and pathophysiology of colonic motor activity. Dig. Dis. Sci. 
36, 827–862 (1991). 
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15. 
Condon, R E, Cowles, Verne, Schulte, William J, Frantzides, Constantinos, 
Matsumoto, T. The effect of whole gut lavage on colon motility and gastrocolic 
response in the subhuman primate. Surgery 99, 531–536 (1986). 
16. 
Sarna, S. K. Myoelectric correlates of colonic motor complexes and contractile 
activity. Am. J. Physiol. 250, G213-20 (1986). 
17. 
Sarna, S. K., Waterfall, W. E. & Bardakjian, B. L. Types of human colonic electrical 
activities recorded postoperatively. Gastroenterology 81, 61–70 (1981). 
18. 
Condon, R. E. et al. Resolution of postoperative ileus in humans. Ann. Surg. 203, 
574–581 (1986). 
19. 
Condon, R. E. et al. Human colonic smooth muscle electrical activity during and after 
recovery from postoperative ileus. Am. J. Physiol. 269, G408-17 (1995). 
20. 
Dua, M. M. et al. Monitoring gastric myoelectric activity after 
pancreaticoduodenectomy for diet “readiness”. Am. J. Physiol. - Gastrointest. Liver 
Physiol. 315, G743–G751 (2018). 
21. 
Navalgund, A. et al. Colon Myoelectric Activity Measured After Open Abdominal 
Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus. J. 
Gastrointest. Surg. 23, 982–989 (2019). 
22. 
Taylor, J. S. et al. Cutaneous patches to monitor myoelectric activity of the 
gastrointestinal tract in postoperative pediatric patients. Pediatr. Gastroenterol. 
Hepatol. Nutr. 22, 518–526 (2019). 
23. 
Frantzides, C T, Cowles, Verne, Salaymeh, Basil, Tekin, Ercument, C. & Robert. 
Morphine effects on human colonic myoelectrical activity in the postoperative period. 
Am. J. Surg. 163, 144–149 (1992). 
24. 
Wolff, B. G. et al. Alvimopan, a novel, peripherally acting μ opioid antagonist: Results 
of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major 
abdominal surgery and postoperative ileus. Ann. Surg. 240, 728–735 (2004). 
25. 
Drake, T. M. & Ward, A. E. Pharmacological management to prevent ileus in major 
abdominal surgery: a systematic review and meta-analysis. Journal of Gastrointestinal 
Surgery 20, 1253–1264 (2016). 
 
 
 
 
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Appendix 1 
10.1.1 COMPOUND AUTHORIZATION AND CONSENT FOR PARTICIPATION IN A 
RESEARCH STUDY 
 
YALE UNIVERSITY SCHOOL OF MEDICINE 
YALE-NEW HAVEN HOSPITAL 
 
 
Study Title: Myoelectric Activity Following Colorectal Surgery and Return of Bowel Function  
Principal Investigator (the person who is responsible for this research): Ira Leeds, MD 
Phone Number: 203-785-2616  
 
Research Study Summary: 
• 
We are asking you to join a research study. 
• 
The purpose of this research study is to evaluate electrical signals made by your 
intestines that tell us how you are recovering after surgery. 
• 
Study procedures will include: small medical-grade patches placed on your skin that 
monitor your intestines and send the information to a smartphone. 
• 
No additional visits are required. 
• 
There are some risks from participating in this study. You may experience a skin reaction 
to the patch if you already have had reactions to other skin adhesives. Data about your 
recovery is shared in a non-identifiable way with the device manufacturer. 
• 
The study may have no benefits to you, but the data collected may help others with a 
similar surgery in the future. 
• 
Taking part in this study is your choice. You can choose to take part, or you can choose 
not to take part in this study.  You can also change your mind at any time.  Whatever 
choice you make, you will not lose access to your medical care or give up any legal 
rights or benefits. How we care for you will not change based on your decision to 
participate. 
• 
If you are interested in learning more about the study, please continue reading, or have 
someone read to you the rest of this document. Take as much time as you need before 
you make your decision. Ask the study staff questions about anything you do not 
understand. Once you understand the study, we will ask you if you wish to participate. If 
you agree, this form will need to be signed to participate. 
 
Why is this study being offered to me? 
We are asking you to take part in a research study because you have a planned surgery 
involving your intestines, colon, or rectum. We are looking for 200 participants 18 years old 
or older to be part of this research study.  
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Who is paying for the study? 
This study has no external funding and is being supported by internal funds. 
 
Who is providing other support for the study? 
The medical device is being provided free of charge by the manufacturer. 
 
What is the study about?  
The purpose of this study is to record the electrical signals that naturally occur in your digestive 
tract and motility patterns in individuals who undergo surgery.  Patients who have surgery 
have the potential to experience delayed recovery of their bowel movements or passing gas. 
Delayed recovery, or ileus, causes the intestinal contents to back up because the bowels do 
not move in a rhythmic way that is needed.  The symptoms resulting from this include painful 
distended abdomen, nausea, vomiting, and dehydration.  A device, the G-Tech Wireless Patch 
System (WPS) has been developed by a company, G-Tech Medical, Inc., which measures the 
electrical activity from your intestines.  The device uses adhesive to adhere to your skin and 
it is placed on your stomach or abdomen to measure the natural electrical activity.  The 
purpose of the study is to determine if the measurements made by the G-Tech Wireless Patch 
System correlate with clinical markers of gastrointestinal recovery such as passage of flatus 
or your first bowel movement, oral tolerance of diet, and discharge readiness. 
 
This study is solely for obtaining patterns in various individuals to determine if the myoelectric 
signals measured by the G-Tech Wireless Patch System correlate with rate of gastrointestinal 
recovery following surgery.    
 
What are you asking me to do and how long will it take?  
The device will be placed post-operatively within 4 hours of your surgery. The patches will 
typically remain on until discharge. You will be asked to return the patches prior to 
discharge. While you are an inpatient, you may shower with the patches in place if the 
surgical team has approved of showering after surgery. 
 
What are the risks and discomforts of participating?  
A potential risk in this study is the adhesive on the patch may cause mild irritation and leave 
temporary red or pink areas or possibly glue marks on your skin, which should go away on 
their own a few days after the patch is removed.    
 
How will I know about new risks or important information about the study?  
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We will tell you if we learn any new information that could change your mind about taking 
part in this study.  
 
What if there are unexpected findings from the study related to my participation? 
We do not anticipate findings that would directly relate to your care as the meaning of the 
data is not yet fully understood and the primary purpose of this study. If the results suggest a 
long-term relevance of the data to your current or future health status, we will communicate 
these findings to you.  
 
How can the study possibly benefit me? 
There are no direct benefits to you for participating in this study.  
 
How can the study possibly benefit other people? 
The results of this study will help the future development of technology and to potentially 
help future patients by optimizing their post-operative care and decrease their length of stay 
in the hospital. 
 
Are there any costs to participation?  
You will not have to pay for taking part in this study. There will be a few minutes of time each 
day for the first 6 days of your inpatient recovery that require your attention with study staff. 
 
Will I be paid for participation?  
This study is conducted without compensation for participants.  
 
How will you keep my data safe and private? 
We will keep information we collect about you confidential. We will share it with others if you 
agree to it or when we have to do it because U.S. or State law requires it.  
 
When we publish the results of the research or talk about it in conferences, we will not use 
your name. If we want to use your name, we would ask you for your permission separately 
from this consent.   
 
We will also share data with other researchers for future research but we will not use your 
name or other identifiers. We will not ask you for any additional permission. 
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What Information Will You Collect About Me in this Study? 
The information we are asking to use and share is called “Protected Health Information.” It is 
protected by a federal law called the Privacy Rule of the Health Insurance Portability and 
Accountability Act (HIPAA). In general, we cannot use or share your health information for 
research without your permission. If you want, we can give you more information about the 
Privacy Rule. Also, if you have any questions about the Privacy Rule and your rights, you 
can speak to Yale Privacy Officer at 203-432-5919. 
 
The specific information about you and your health that we will collect, use, and share 
includes: 
• Research study records 
• Medical and laboratory records of only those services provided in connection with this 
Study.   
• The entire research record and any medical records held by Yale New Haven Hospital 
from the month of your booking for surgery to the month after your discharge for 
surgery. 
• Records about phone calls made as part of this research 
• Records about your study visits 
• Information obtained during this research regarding 
 
HIV / AIDS test results 
 
Hepatitis infection 
 
Sexually transmitted diseases 
 
Other reportable infectious diseases 
 
Physical exams 
 
Laboratory, x-ray, and other test results 
 
Diaries and questionnaires 
 
The diagnosis and treatment of a mental health condition 
 
Use of illegal drugs or the study of illegal behavior 
 
Records about any study drug you received 
 
Records about the study device 
 
 
How will you use and share my information? 
We will use your information to conduct the study described in this consent form.  
We may share your information with: 
• 
The U.S. Department of Health and Human Services (DHHS) agencies 
• 
Representatives from Yale University, the Yale Human Research Protection Program 
and the Institutional Review Board (the committee that reviews, approves, and monitors 
research on human participants), who are responsible for ensuring research 
compliance.  These individuals are required to keep all information confidential.  
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• 
The U.S. Food and Drug Administration (FDA) This is done so that the FDA can review 
information about the device involved in this research.  The information may also be 
used to meet the reporting requirements of drug regulatory agencies.   
• 
The study sponsor or manufacturer of study drug/device 
• 
Drug regulatory agencies in other countries 
• 
Governmental agencies to whom certain diseases (reportable diseases) must be 
reported 
• 
Health care providers who provide services to you in connection with this study. 
• 
Laboratories and other individuals and organizations that analyze your health 
information in connection with this study, according to the study plan. 
• 
Principal Investigator of the study 
• 
Co-Investigators and other investigators  
• 
Study Coordinator and Members of the Research Team  
• 
Data and Safety Monitoring Boards and others authorized to monitor the conduct of the 
Study  
 
We will do our best to make sure your information stays private. But, if we share information 
with people who do not have to follow the Privacy Rule, your information will no longer be 
protected by the Privacy Rule. Let us know if you have questions about this. However, to 
better protect your health information, agreements are in place with these individuals and/or 
companies that require that they keep your information confidential. 
 
Why must I sign this document? 
By signing this form, you will allow researchers to use and disclose your information 
described above for this research study. This is to ensure that the information related to this 
research is available to all parties who may need it for research purposes. You always have 
the right to review and copy your health information in your medical record.  
 
What if I change my mind? 
The authorization to use and disclose your health information collected during your 
participation in this study will never expire.  However, you may withdraw or take away your 
permission at any time. You may withdraw your permission by telling the study staff or by 
writing to Ira Leeds, MD (789 Howard Ave, Tompkins 202, New Haven, CT 06519) at Yale 
University, New Haven, CT 06520. 
 
If you withdraw your permission, you will not be able to stay in this study but the care you get 
from your doctor outside this study will not change.  No new health information identifying 
you will be gathered after the date you withdraw. Information that has already been collected 
may still be used and given to others until the end of the research study to insure the 
integrity of the study and/or study oversight.   
 
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Who will pay for treatment if I am injured or become ill due to participation in the 
study?  
Because this study only involves recording your electrical activity in your abdomen, it is 
unlikely that you will experience injury related to this study.   Should you experience injury, 
you should see your physician. You and your insurance company may be billed for medical 
care.    
 
What if I want to refuse or end participation before the study is over?  
 
Taking part in this study is your choice. You can choose to take part, or you can choose not 
to take part in this study.  You also can change your mind at any time.  Whatever choice you 
make, you will not lose access to your medical care or give up any legal rights or benefits.  
 
We would still treat you with standard therapy or, at your request, refer you to a clinic or 
doctor who can offer this treatment. Not participating or withdrawing later will not harm your 
relationship with your own doctors or with this institution.   
 
To withdraw from the study, you can call a member of the research team at any time and tell 
them that you no longer want to take part.   
 
If you develop side effects, the researchers may withdraw you from participating in the 
research study. If you are unable to tolerate wearing the device in its proscribed fashion, you 
may be withdrawn from the study by the research team. 
 
 
What will happen with my data if I stop participating? 
Data already transmitted to the device manufacturer will not be able to censored. 
 
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Who should I contact if I have questions?  
 
Please feel free to ask about anything you don't understand.  
 
If you have questions later or if you have a research-related problem, you can call the 
Principal Investigator at 203-785-2616  
 
If you have questions about your rights as a research participant, or you have complaints 
about this research, you call the Yale Institutional Review Boards at (203) 785-4688 or email 
hrpp@yale.edu. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the 
Web site will include a summary of the results. You can search this Web site at any time. 
 
 
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Authorization and Permission 
 
Your signature below indicates that you have read this consent document and that you 
agree to be in this study.   
 
We will give you a copy of this form. 
 
 
Participant Printed Name 
 
Participant Signature 
 
Date 
Person Obtaining Consent Printed 
Name 
 
Person Obtaining Consent Signature 
 
Date 
 
 
 
Complete if the participant is not fluent in English and an interpreter was used to obtain 
consent.  Participants who do not read or understand English must not sign this full 
consent form, but instead sign the short form translated into their native language.  This 
form should be signed by the investigator and interpreter only.  If the interpreter is 
affiliated with the study team, the signature of an impartial witness is also required. 
 
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Print name of interpreter: ______________________________________ 
 
Signature of interpreter: ___________________________________    Date: _________ 
 
An oral translation of this document was administered to the participant in _____________ 
(state language) by an individual proficient in English and ____________ (state 
language).  
Print name of impartial witness: __________________________________ 
 
Signature of impartial witness: ________________________________Date: _________ 
 
See the attached short form for documentation. 
 
 
 
 
 
 
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Appendix 2 
Screening, Eligibility, and Demographics Form 
 
SCREENING  
Patient ID #__________________ 
Planned Surgery (pick one) 
 
Enterectomy Only 
Right-sided Colectomy 
 
Left-sided Colectomy 
 
Proctectomy 
Date of Planned Surgery __/__/___ 
 
ELIGIBILITY 
1. Inclusion Criteria (All responses must be “YES” below) 
YES 
NO 
a. 
Subject is willing and able to provide informed consent; 
 
 
b. 
Subject is ≥ 18 years of age; 
 
 
c. 
Subject is willing and able to follow all study requirements; 
 
 
d. 
Subject who will undergo or has undergone open or laparoscopic 
colorectal surgery 
 
 
2. Exclusion Criteria (All responses must be “NO” below) 
YES 
NO 
a. 
Subject has a known allergy to skin adhesives; 
 
 
b. 
Subject is pregnant or suspects pregnancy; 
 
 
 
2. Informed Consent Obtained 
a. Informed Consent Obtained  
 
 
 
 
Y  
N 
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b. Date of Informed Consent ___/___/__ 
1. Demographics  
1. 
Date of Birth 
____ ____ / ____ ____ / ____ ____ ____ ____ 
                MM                DD                        YYYY 
2. 
Gender 
 Male                  
 Female 
3. 
Stated Height 
____ Feet     ____ Inches 
4. 
Stated Weight 
____ ____ ____ lbs. 
5. 
Ethnicity 
Caucasian   
Black   
Hispanic   
 Asian  
Other: 
_______________ 
 
 
 
 
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Appendix 3 
Recording Procedure and Clinical Markers Case Report 
Form 
Patient ID #__________________ 
Date of Surgery ____/_____/_____ 
Procedure Performed (pick one)  
 
 
Ostomy Preop? Y   N 
 
Enterectomy Only 
 
 
 
 
Ostomy post?   Y    N 
Right-sided Colectomy 
 
Left-sided Colectomy 
 
Proctectomy 
POSTOPERATIVE MARKERS 
First Flatus Date ____/_____/_______ 
First BM Date    _____/_____/_______ 
First Solid Food _____/_____/_______ 
 
Clinical Ileus (emesis after POD 2, no flatus, reversal of diet order, +/- NGT placed)     
Y     N 
Readmission    Y    N 
Reason for Readmission (choose any) 
 
[ ] Ileus 
 
[ ] Dehydration 
 
[ ] Infection / Anastomotic Leak 
 
[ ] VTE 
 
[ ] Unknown 
 
[ ] Other: 
Readmission likely related to surgery?  Y   N 
 
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Appendix 4 
Protocol Deviation Form 
Date(s) Deviation Occurred:  
_________________________________________________________ 
(If this deviation occurred over multiple days, please indicate entire deviation period) 
Associated Study Visit (if applicable):  
__________________________________________________ 
Type of Deviation 
 Informed consent not properly obtained 
 Study procedure performed prior to consent 
 Subject enrolled outside inclusion/exclusion criteria 
 Required evaluation not performed 
 Follow up visit missed (specify visit in 2 above) 
 Follow up visit out of window (specify visit in 2 above) 
 Device used outside protocol requirements 
 Other deviations (specify in deviation description) 
Describe Deviation in Detail: 
 
 
 
Date Manufacturer Notified (if applicable): _________________________________ 
Name of Individual Notified (if applicable): 
___________________________________________ 
Was an Exemption Granted? 
 Yes, date:  ____________________ 
 No 
Did Deviation Meet IRB/EC Reporting Requirements?  Yes, date reported:  
_______________ 
 No 
Corrective Actions Taken (if required, otherwise, state N/A): 
 
 
 
 
 
 
 
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Appendix 5 
 
Study Exit Form 
 
1.1. Patient ID #__________________ 
1.2. Date of Study Exit:  _____________ 
1.3. Associated Study Visit (if applicable):  
________________________________________ 
1.4. Reason for Study Exit 
 Completed study visits as planned: if checked, skip to Principal Investigators’ 
signature 
 Screen Failure: if yes State reason for screen failure 
_______________________________ 
 Voluntary subject withdrawal, e.g., no longer wanted to participate 
 Investigator decision to withdraw subject from the study 
____________________________ 
 Other 
 
 
 
 
 
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Appendix 6 
 
Adverse Event Form 
 
 
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