Capsule Endoscopy for Hemorrhage in the ER
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Sponsor: George Washington University

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Capsule Endoscopy for HEmorrhage in the ER (CHEER) 
Protocol Identifying Number: ISR-2016-10770  
Principal Investigator: Andrew Meltzer 
George Washington University School of Medicine and Health Sciences 
Investigator Initiated Research 
Funded by Medtronic 
Version Number:  v.5 
9/27/19 
  
 
 

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STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the International Conference on Helsinki 
guidelines for Good Clinical Practice (ICH E6), and the Code of Federal Regulations on the 
Protection of Human Subjects (45 CFR Part 46). All personnel involved in the conduct of this 
study have completed human subjects’ protection training.   

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SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments provide the 
necessary assurances that this study will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, according to local legal and 
regulatory requirements and applicable US federal regulations and ICH guidelines. 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
 
 
Name:  
 
Title:  
 

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TABLE OF CONTENTS 
 
 
PAGE 
STATEMENT OF COMPLIANCE ................................................................................................ 3 
SIGNATURE PAGE .................................................................................................................... 4 
TABLE OF CONTENTS .............................................................................................................. 5 
LIST OF ABBREVIATIONS ......................................................................................................... 8 
PROTOCOL SUMMARY ............................................................................................................. 9 
1 
KEY ROLES AND CONTACT INFORMATION ................................................................. 11 
2 
INTRODUCTION:  BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ...... 13 
2.1 
Background Information ........................................................................................ 13 
2.2 
Rationale .............................................................................................................. 16 
2.3 
Potential Risks and Benefits ................................................................................. 16 
2.3.1 
Potential Risks .......................................................................................... 16 
2.3.2 
Potential Benefits ...................................................................................... 18 
3 
OBJECTIVES ................................................................................................................... 19 
3.1 
Study Objectives ................................................................................................... 19 
3.2 
Study Outcome Measures .................................................................................... 19 
4 
STUDY DESIGN .............................................................................................................. 21 
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................. 23 
5.1 
Subject Inclusion Criteria ...................................................................................... 23 
5.2 
Subject Exclusion Criteria ..................................................................................... 23 
5.3 
Strategies for Recruitment and Retention ............................................................. 23 
5.4 
Subject Withdrawal ............................................................................................... 24 
5.4.1 
Reasons for Withdrawal ............................................................................ 24 
5.4.2 
Handling of Subject Withdrawals ............................................................... 24 
5.5 
Premature Termination or Suspension of Study .................................................... 24 
6 
STUDY TIMETABLE ........................................................................................................ 25 
6.1 
Time line ............................................................................................................... 25 
6.2 
Data Collection Period .......................................................................................... 25 
6.3 
Final Analysis ....................................................................................................... 25 
7 
STUDY PROCEDURES ................................................................................................... 26 
7.1 
Screening and Randomization .............................................................................. 26 
7.2 
Procedural Treatment Protocol ............................................................................. 26 
7.3 
Study Outcomes ................................................................................................... 26 
7.3.1 
Primary Outcomes..................................................................................... 26 
7.3.2 
Secondary Outcomes ................................................................................ 26 
7.4 
Baseline Procedures ............................................................................................. 26 
7.5 
Patient Management and Follow-up ...................................................................... 26 
7.6 
Adverse Event Reporting ...................................................................................... 27 
8 
QUESTIONNAIRE ADMINISTRATION ............................................................................ 29 
8.1 
Cheer 1 Screening Log ......................................................................................... 29 
Screening Log lists all patients screened for the study and some demographic data. ....... 29 
8.2 
Cheer 2 Eligibility and Randomization Form ......................................................... 29 

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8.3 
Cheer 3 Patient Data Collection Form ................................................................... 29 
Patient data collection form is completed for all randomized patients. This form 
includes detailed medical data obtained during screening for the study. ............... 29 
8.4 
Cheer 4:  Video Capsule Endoscopy Data Collection sheet .................................. 29 
This form is completed by the Gastroenterologist completed the VCE read. ..................... 29 
8.5 
Cheer 5: EGD Data Collection Sheet .................................................................... 29 
This form is completed by the Gastroenterologist completing the EGD read 
Interpretation Form. .............................................................................................. 29 
8.6 
Cheer 6 Patient Satisfaction .................................................................................. 29 
This form is completed during the day 7 and day 30 follow up contact. ............................ 29 
8.7 
Cheer 7:  Patient Follow up ................................................................................... 29 
8.8 
Cheer 8: Hospitalization Course/ Chart Review .................................................... 29 
8.9 
Cheer 9:  Adverse Event Form/ Serious Event From............................................. 30 
9 
WEB DATA ENTRY SYSTEM .......................................................................................... 31 
10 
ASSESSMENT OF SAFETY ............................................................................................ 32 
10.1 
Unanticipated Problems ........................................................................................ 32 
10.1.1 Capsule Retention, Capsule Retention, Group Crossover ......................... 32 
10.2 
Serious Adverse Events ........................................................................................ 32 
10.3 
Reporting Procedures ........................................................................................... 32 
11 
HYPOTHESIS AND ANALYSIS ....................................................................................... 33 
11.1 
Study Hypotheses ................................................................................................. 33 
11.2 
Sample Size Considerations ................................................................................. 33 
11.3 
Final Analysis Plan ............................................................................................... 33 
11.4 
Cost-Effective Analysis ......................................................................................... 33 
12 
STUDY OVERSIGHT ....................................................................................................... 34 
12.1 
Site Visits .............................................................................................................. 34 
12.2 
Monthly Reports .................................................................................................... 34 
12.3 
Annual Reports ..................................................................................................... 34 
13 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .................. 35 
14 
QUALITY CONTROL AND QUALITY ASSURANCE ........................................................ 36 
15 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................. 37 
15.1 
Good Clinical Practices ......................................................................................... 37 
15.2 
Institutional Review Board .................................................................................... 37 
15.3 
Informed Consent Process ................................................................................... 37 
15.4 
Exclusion of Women, Minorities, and Children (Special Populations) .................... 37 
15.5 
Participant Confidentiality ..................................................................................... 37 
16 
DATA HANDLING AND RECORD KEEPING ................................................................... 38 
16.1 
Data Management Responsibilities ....................................................................... 38 
16.2 
Data Capture Methods .......................................................................................... 38 
16.3 
Schedule and Content of Reports ......................................................................... 38 
16.4 
Study Records Retention ...................................................................................... 38 
16.5 
Protocol Deviations ............................................................................................... 38 
17 
PUBLICATION/DATA SHARING POLICY ........................................................................ 39 
18 
LITERATURE REFERENCES .......................................................................................... 40 

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APPENDICES ........................................................................................................................... 41 
18.1 
APPENDIX A: Schedule of Events ........................................................................ 41 
18.2 
APPENDIX B – Document List .............................................................................. 42 
18.3 
 Screening Log...................................................................................................... 43 
18.4 
Patient Screening ................................................................................................. 44 
18.5 
Patient Data Collection ......................................................................................... 47 
18.6 
Patient Screening:  GBS Score ............................................................................. 48 
18.7 
Patient Lab Values Pre PillCam ............................................................................ 49 
18.8 
Patient Lab Values Post PillCam .......................................................................... 49 
18.9 
PillCam Data Collection ........................................................................................ 50 
18.10 EGD Data Collection ............................................................................................. 51 
18.11 Patient Satisfaction Day 7 and Day 30 .................................................................. 52 
18.12 Patient Follow-up Telephone Call Day 7 and Day 30 ............................................ 52 
18.13 Patient Chart Review ............................................................................................ 53 
18.14 Adverse Event Form ............................................................................................. 55 
18.15 Protocol Deviation ................................................................................................. 56 
 

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LIST OF ABBREVIATIONS 
AC 
Active Control 
CE 
Capsule Endoscopy (Risk Assessment) 
CERA 
Capsule Endoscopy Risk Assessment 
CFR 
Code of Federal Regulations 
CHEER 
Capsule Endoscopy for HEmorrhage in the ER 
CORE 
Central Reading Group for Endoscopy 
ED 
Emergency Department 
EGD 
Esophagogastroduodenoscopy 
GBS 
Glasgow Blatchford Score 
GI 
Gastrointestinal 
ICH 
International Conference on Harmonization 
IRB 
Institutional Review Board 
NIH 
National Institutes of Health 
RC 
Research Coordinator 
ST 
Standard (Risk Assessment)  
UGIB 
Upper GI Bleed 
US 
United States 
VCE 
Video Capsule Endoscopy 
 

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PROTOCOL SUMMARY 
Title: 
Capsule Endoscopy for HEmorrhage in the ER (CHEER) 
Précis: 
This is a multi-center randomized controlled trial examining the use 
of Video Capsule Endoscopy (VCE) to discharge low-moderate risk 
patients with suspected upper gastrointestinal bleeds (UGIB) from 
the Emergency Department (ED.) We will enroll 100 subjects at 4 
sites who present with signs of hemodynamically stable UGIBs and 
compare VCE risk assessment to an Active Control (AC) group who 
receive inpatient upper endoscopy (EGD).   
Objectives: 
Primary:  Our primary goal is to determine whether ED VCE is able 
to discharge low risk patients for outpatient management of upper GI 
bleeds.   
 
Secondary:  Our secondary objective is to estimate the sensitivity 
and specificity of VCE compared to subsequent EGD in the detection 
of serious bleeding lesions in the upper gastrointestinal (GI) tract. 
 
Sample size is 100 patients, age ≥  18 in 4 urban EDs, mixed 
gender, mixed race, hemodynamically stable with possible co-
morbidities. 
Population: 
Study subjects will be enrolled from larger pool of adult ED patients 
presenting with acute overt UGIB defined as bloody emesis and/or 
coffee ground vomiting and/or melena within the previous 48 hours. 
Number of Sites: 
4 
Study Duration: 
12 months 
Subject Participation 
Duration: 
30 days 
Estimated Time to 
Complete 
Enrollment: 
1 year 
 
 
 

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CERA 
AC 
Schematic of Study Design: 
ED Visit 
Prior to  
 
Enrollment 
 
 
 
Time Point 0 
 
 
15 – 20 minutes 
 
 
 
 
 
ED Visit 
Time 
Point 1 
0-100 minutes 
(Estimated) 
 
 
ED Visit 
Time Point 2 
<120 minutes  
+ 20-90mins  
(Estimated) 
 
 
Observation/ 
Admission 
Time Point 3 
 
 
 
 
Outpatient EGD 
Time Point 4 
 
 
 
 
 
Telephone Call 
Time Point 5 
Day 7 
 
 
 
Chart Review 
Time Point 5 
Day 30 
 
 
Final Assessments- Chart Review for Serious 
Adverse Events at Day 7 (Mortality, Re-
Bleeding, Total Blood Transfusions, Surgery, 
Capsule-specific). Mail reimbursement card.  
Complete electronic data entry.  
Total 100: Screen potential subjects for inclusion and exclusion criteria: order 
labs, obtain history and document. 
 
Administer pro-motility agent (Reglan 10mg 
IVP or Erythromycin 500mg IV). Set up 
equipment for VCE.  Alert CORE for CERA 
Group. 
• Subject ingests VCE, Video 20-90 minutes 
until reaches duodenum or battery shuts off.  
 
Inpatient EGD (approx. within 
24 hours) 
Communicate with Clinical Staff, 
Consent and Randomize Subjects to 
Telephone Call: (1) Serious Adverse Events? (2) Patient Satisfaction. 
 
 
Patient will be monitored for minimum of 4 
hours. VCE will be read by CORE 
ENDOSCOPY READING GROUP.  Repeat CBC 
at q4 hours.  
(Admitted) 
 
Patient follow up EGD within 3 
days (approx.) 
 
 
Stable X 4 Hours -> 
Discharge Home 
Unstable or High-
Risk VCE 

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1 KEY ROLES AND CONTACT INFORMATION 
Andrew C. Meltzer MD MS, Principal Investigator 
Associate Professor 
George Washington University School of Medicine and Health Sciences 
2120 L Street NW Suite 450 
Washington, DC 20037 
202-445-7044 (Cell) 
ameltzer@mfa.gwu.edu 
 
Melanie Bossi MPA, Regulatory Specialist 
Assistant Director, Clinical Research 
George Washington University Medical Faculty Associates 
2150 Pennsylvania Avenue NW Suite 8-416 
Washington, DC 20037 
202-741-2483 
mbossi@mfa.gwu.edu 
 
Nataly Montano, Lead Research Coordinator 
Clinical Research Coordinator 
George Washington Medical Faculty Associates 
Department of Emergency Medicine 
2120 L Street NW, Suite 450 
Washington, DC 20037 
202-741-2917 
nmontano@mfa.gwu.edu 
 
Yan Ma, MA, MS, PhD, Biostatistician  
Departments of Epidemiology and Biostatistics 
Milken Institute School of Public Health 
George Washington University 
950 New Hampshire Ave, NW 5th floor 
Washington, DC  20052 
202-994-0955 
yanma@gwu.edu 
 
Nina Gentile, MD, Temple Site Investigator 
Department of Emergency Medicine 
Lewis Katz School of Medicine at Temple University 
3401 North Broad Street 
Philadelphia, PA 19140 
nina.gentile@tuhs.temple.edu 
 
 
 

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Alexander T. Limkakeng, Jr., MD, MHSc, Duke Site Investigator 
Division of Emergency Medicine  
Duke University School of Medicine  
Box 3096, Office 2611 
Durham, NC 27710 
(919) 681-0196 
Alexander.limkakeng@duke.edu  
 
 
 

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2 INTRODUCTION:  BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
2.1 
Background Information 
Upper gastrointestinal (GI) hemorrhage is the primary diagnosis for 300,000 annual Emergency 
Department (ED) admissions in the US.  The challenge for the ED is to determine whether a 
patient with a suspected upper GI bleed (UGIB) needs urgent intervention (i.e. hospital 
admission for endoscopy, surgery and/or transfusion) or can be safely discharged for outpatient 
management.  The Glasgow-Blatchford Score (GBS) was developed to identify GI bleeds that 
require hospital admission and urgent intervention.  The GBS has a high sensitivity but low 
specificity.  For high risk bleeds, standard of care is hospital admission and a performance of 
esophagogastroduodenoscopy (upper endoscopy or EGD) within 24 hours.  However, many US 
hospitals do not have the resources to perform EGD on all patients suspected to have UGIB 
within 24 hours of admission.1 As a result, a significant proportion of patients with low-risk 
bleeds are admitted to the hospital for observation and may never receive EGD and many 
patients with high-risk lesions receive delayed care because of the inability to discriminate low 
risk from high risk bleeding events.  
 
Video capsule endoscopy (VCE) was initially approved in 2001 by the Food and Drug 
Administration as a noninvasive diagnostic test for occult UGIB. This technology represented a 
signiﬁcant advance in the investigation of intestinal diseases. Indications that have been 
validated include cryptogenic gastrointestinal bleeding, familial polyposis, and intestinal lesions 
in patients with Crohn's disease. Based on recent evidence, VCE represents a novel strategy to 
perform rapid diagnosis of suspected UGIB, portal hypertension, non-cardiac chest pain, 
gastroesophageal reflux disease in the emergency department (ED).  There are limited numbers 
of EDs in the United States that have used VCE on trial- and protocol-based patient studies, but 
the results are encouraging.2 Given the expanding role of advanced diagnostic and point-of-care 
testing in US EDs, VCE has great potential for future evaluation of ED gastrointestinal 
complaints. 
 
VCE offers potential advantages over traditional EGD including the ability to be performed 24 
hours a day without sedation and interpreted at the bedside by emergency physicians. In 
addition, VCE is much less invasive, is painless, and enables the patient to pursue normal daily 
activities after the procedure. ED physicians may use the information to make real-time 
decisions regarding the need for hospitalization, endoscopic hemostasis, and risk stratification. 
Real-time imaging has been shown to be helpful in early diagnosis of bleeding lesions [1], and 
the videos generated can be sent to an off-site specialist for an over-read after the initial ED 
interpretation. This workﬂow is similar to that of many current ED diagnostic tests such as 
electrocardiograms and radiology examinations. This ability to transmit images could become 
especially important in rural communities or in communities that have limited access to a 
gastroenterologist. Incorporation of VCE into ED practice could follow a trajectory similar to that 
of point-of-care ultrasonography, an imaging modality in which ED physicians have become 
increasingly skilled and for which indications continue to expand [2]. 
 
In patients requiring VCE, most contraindications are relative and the procedure has been 
performed safely in a variety of clinical settings [3]. Pacemakers and other electrical medical 

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devices are not a contra- indication to the procedure with newer versions of the capsules. The 
only absolute contraindications are bowel obstruction and pregnancy [4]. There is a low risk of 
non-natural excretion of the capsule estimated at less than 1 in 100 [5]. In general, the 
procedure poses signiﬁcantly less risk than traditional EGD, and multiple studies have shown 
that VCE is well tolerated in ED patients with suspected acute UGIB [6-8]. 
 
The American Society of Gastrointestinal Endoscopy states that credentials for VCE should be 
determined independently from other endoscopic procedures such as colonoscopy, 
sigmoidoscopy, or any other endoscopic procedure [9]. The American Society of 
Gastrointestinal Endoscopy emphasizes sound medical training, appropriate patient selection, 
correct interpretation, and continued medical management for all patients. VCE requires only 
image interpretation and does not require procedural skill training associated with other 
endoscopic procedures; therefore, ED physicians can meet these criteria with basic training.3  
 
In a study of 25 subjects, VCE interpretation by emergency physicians demonstrated excellent 
agreement with gastroenterologists for the presence of fresh or coffee-ground blood (0.96 
overall agreement; κ ¼ 0.90) [7]. In another study, 126 emergency physicians were asked to 
look at standardized videos from ED patients who presented with acute UGIB. Compared with 
expert gastroenterology-adjudicated interpretation, the sensitivity of ED physicians to detect 
blood was 0.94% (95% CI: 91%-96%) and speciﬁcity was 87% (95% CI: 80%-92%) [10]. 
 
Gastrointestinal hemorrhage is a common emergency condition, and the severity ranges from 
benign to life threatening. Risk stratiﬁcation of acute UGIB is challenging in the ED because 
traditional diagnostic approach using the physical exam, lab testing and radiographic studies is 
too nonspecific to be used without adjunctive endoscopy. As a result, many patients with an 
ultimately benign clinical course are admitted to the hospital and incur considerable costs. 
Without an ED-based endoscopy, alternative means to risk stratify patients with signs of UGIB 
include performing nasogastric aspiration, which is uncomfortable for patients [11], using clinical 
decision rules, such as the Rockall Risk Score and Glasgow-Blatchford Score, or admitting all 
patients with suspected upper gastrointestinal bleed for endoscopy [12]. 
 
Most endoscopy capsules are manufactured for use in the small bowel, but the esophageal 
capsule endoscope (PillCam UGI, Medtronic) is designed to visualize the upper gastrointestinal 
tract. The esophageal VCE is equipped with 2 cameras at either end that take 35 pictures per 
second for 30 minutes. Initial studies with early-generation esophageal VCE demonstrated a 
sensitivity of 92% and speciﬁcity of 95% to diagnose chronic reﬂux esophagitis [13]. In addition, 
the sensitivity and the speciﬁcity were found to be 97% and 99%, respectively, for the diagnosis 
of Barrett esophagus and 89% and 99%, respectively, for diagnosis of esophagitis [13]. 
 
The use of esophageal VCE in the ED to directly visualize the upper gastrointestinal tract and 
identify presence or absence of blood is a novel approach that has been studied in 4 ED-based 
studies. First, Rubin et al [14] studied 24 patients who presented to the ED with signs of UGIB. 
In this study, patients were randomized to either receive a VCE in the ED with real-time 
interpretation or receive standard care. Of the 12 patients in the experimental group, 7 had 

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bleeding detected on VCE and all had bleeding conﬁrmed with subsequent EGD within 6 hours 
of hospital admission. Of the 4 patients who had a negative result on VCE (1 could not tolerate 
a VCE), all 4 had subsequent negative ﬁndings on EGD. On average, patients in the 
experimental group had an EGD performed sooner than the control group, but there was no 
change in clinical outcomes. 
 
Gralnek et al [6] studied 41 patients who presented to the ED with UGIB and each received both 
a nasogastric tube and VCE. All patients had an EGD performed in the hospital within 12-24 
hours after presentation. Of the 41 patients, 18 had blood in the upper gastrointestinal tract 
detected by EGD; capsule endoscopy detected blood in 83% (15/18) of these cases compared 
with a nasogastric aspiration, which detected blood in 33.3% (6/18). It is important to note that in 
9 of these patients, the capsule detected blood in the duodenum, when nasogastric aspiration 
was reported to be either clear or bilious. Lack of detection of post-pyloric bleeding is an 
important limitation of nasogastric aspiration. Patients preferred VCE over nasogastric 
aspiration. 
 
A third study conducted in the ED on the use of VCE enrolled 25 subjects with acute upper 
gastrointestinal hemorrhage [7]. In this study, Meltzer et al demonstrated an 88% sensitivity 
(95% CI: 65%- 100%) and 64% speciﬁcity (95% CI: 35%-92%) for the detection of fresh blood 
compared with an EGD performed with 24 hours. Capsule endoscopy missed a bleeding lesion 
located in the post- pyloric region, which was not imaged because of expired battery life (30 
minutes). 
 
Most recently, the use of esophageal VCE in the ED was compared with the validated triage 
system, the Glasgow-Blatchford Score, to identify the number of patients who may be suitable 
for outpatient care [8]. Patients who presented to the ED for suspected acute UGIB were 
enrolled and administered esophageal VCE. For capsules that passed the pylorus and reached 
the duodenum, high-risk lesions were detected with a 95% sensitivity (95% CI: 72%-100%) and 
a 92% speciﬁcity (95% CI: 73%- 99%) compared with the Blatchford Score that demonstrated a 
94% sensitivity (95% CI: 72%-100%) and a 16% speciﬁcity (95% CI: 5%-37%). 
 
There has been one feasibility study published to test whether VCE can reduce hospital 
admissions in patients with suspected UGIB. In a prospective randomized controlled trial in 
which patients who presented with symptoms or signs suggestive of UGIB were randomized to 
receive either the standard treatment of hospital management versus VCE.  Patients were also 
graded by Glasgow Blatchford score (GBS) at the ED for assessment of need of hospital 
admission. In this study, seventy-one patients fulfilled the recruitment criteria, with 37 subjects 
randomized to the VCE group and 34 subjects randomized to standard group. Seven VCE 
patients with active bleeding or significant endoscopic findings were admitted to the hospital 
compared with the standard group in which all 34 patients were admitted. There was no 
difference in the clinical outcome in terms of recurrent bleeding and 30-day mortality. In 
addition, hospital admission was also greatly reduced if VCE results were used instead of the 
GBS to determine whether patients were admitted or managed in the outpatient setting.[9]  
 

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In all ED studies that have been conducted for acute upper gastrointestinal hemorrhage, VCE 
has performed well when it travels through the pylorus. However, several high-risk lesions were 
missed if the VCE did not travel through the pylorus before the battery expired. The time to pass 
the pylorus is variable. At 60 minutes, 98% of capsules visualize the duodenum [6]; when the 
battery life is only approximately 20-30 minutes, approximately 50% visualize the duodenum 
(12/25 [7], 44/83 [8], and 7/12 [14]). In one study, the single missed active bleeding occurred in 
a patient who was bleeding in the post-pyloric duodenum and in whom the VCE battery expired 
before reaching the post-pyloric region [7]. For standard EGD, the use of pro-kinetic agents 
such as erythromycin or metoclopramide has improved mucosal visualization and has been 
increasingly used before the procedure. This strategy, combined with 60 minutes of 
visualization, will likely increase the accuracy of VCE as well. 
 
The cost of the VCE is an important factor that affects future use in the ED. The physician 
Medicare national average fee is $705 for the PillCam UGI and $50 for the professional fee. 
Although expensive, VCE may be cost-effective if it safely reduces hospital admissions or 
emergency EGD. For comparison, in 2011, 236,000 patients received an EGD (International 
Classiﬁcation of Diseases, Ninth Revision code 45.13) in the hospital for an upper UGIB, the 
median length of stay was 4.0 days, and the median charges were $23,549.17 [12]. 
 
A decision-analytic model showed that VCE is cost effective for low- to moderate-risk patients 
despite increased upfront costs compared with clinical decision rules or nasogastric tubes. The 
use of VCE in the ED can potentially lead to more patients being safely discharged from the ED. 
The hospital admission is the single most expensive decision made by an emergency physician. 
Chandran et al [8] showed that the higher sensitivity of VCE compared with the Glasgow-
Blatchford Score would have saved $1691 per VCE by increasing the number of patients who 
could receive an outpatient EGD. 
 
Currently, the VCE does not replace the need for traditional EGD when hemostasis or biopsy is 
needed. Technological advancements may allow a VCE operator to control movement of the 
capsule, collect biopsy samples, and perform therapeutic functions. 
2.2 
Rationale 
We believe there is an opportunity to improve the risk stratification of acute UGIB that presents 
to the Emergency Department through the use of Video Capsule Endoscopy. Our primary 
hypothesis is that VCE allows for safe outpatient management of ED patients with suspected 
upper GI hemorrhage.  A multicenter randomized control trial is proposed to investigate the 
safety of this diagnostic modality. 
2.3 
Potential Risks and Benefits 
2.3.1 
Potential Risks 
Patients for whom study enrollment may interfere with standard clinical care will not be enrolled.  
Alternatives to study participation are for patient to receive standard of care treatment for UGIB.  

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We have considered a variety of potential risks to participants including cognitive, affective, 
physical, legal/confidentiality and economic risks. The PillCam UGI is manufactured by 
Medtronic and has been FDA approved with a robust published safety profile since approval in 
2004.  
The physical risks associated with the PillCam are generally related to potential non-natural 
excretion.  There is a small risk that the capsule could become stuck in the stomach or bowel. 
Based on published and unpublished data, the PillCam Small Bowel (SB) capsule has been 
reported to be retained in the GI tract for periods of at least 23 months without adverse events. 
The capsule has been shown to remain intact, without symptoms, for months. In fact, a large 
retrospective review by Chaifetz, et al. found that a retained capsule often leads to a diagnosis. 
Furthermore, the device is made of biocompatible materials and its internal parts are non-toxic. 
The incidence of capsule retention has been reported to be less than 1% but this figure may be 
higher in Crohn's disease or other conditions. The rate of surgical removal was noted to be 
0.75% (Barkun JS, Friedman S. Am J Gastroentrol 2002; 97:A83).  
Surgery may be required to remove a retained capsule. In general, if a patient does not pass the 
PillCam naturally through the upper GI tract due to gastroparesis, an EGD will be sufficient to 
retrieve the capsule.  Given that most patients will receive an EGD as part of their standard 
work-up for the disease, this does not pose a significant increased risk. Patients who are at 
increased risk of capsule retention are not appropriate study subjects including people with 
swallowing disorders or with known or suspected gastrointestinal obstructions, strictures or 
fistulas.    
Pregnant women will not be included.  
Also, people with cardiac pacemakers or other implanted electro-medical devices will not be 
given the PillCam given a theoretical risk that the devices could interact.  
Patients will be advised not to have an MRI for 30 days and to consult with their doctor prior to 
receiving an MRI in the future.  For patients who are unsure whether they excreted the PillCam, 
an abdominal X-Ray may be required as an outpatient to confirm passage. 
In order to maximize safety for all study subjects, only consented and enrolled subjects will be 
administered the PillCam under the personal supervision of the PI or under the supervision of a 
sub-investigator/trained research associate responsible to the PI.  In addition, the PillCam will 
be stored in a secure, limited access area. Product accountability log must include the protocol 
number, investigative site name, product name, medical units (i.e., video capsules), serial 
number and subject ID number.  
We anticipate low cognitive risk to participants.  Diagnosis of source of gastrointestinal bleeding 
lesion is presumably one of the reasons the patient presented for emergency care.  We do not 
anticipate an affective risk to participants.  Some participants may be bothered by the 
knowledge that the device will pass naturally and may take several days to be excreted.   
We believe the study poses a low privacy risk to subjects as all data will be encrypted and no 
PHI will be stored with data.   

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Finally, the study has a low economic risk since the device and the interpretation of the device 
are not being billed to the subject or his/her insurance company.  The only economic risk may 
result from an unanticipated complication of the device that will not be covered by Medtronic, 
LTD, the manufacturer of the pill camera, GWUH or MFA. 
Minor adverse events that occur will be reported directly to the principal investigator and overall 
study coordinator at the next business day.  Minor adverse events include inability to tolerate 
capsule, discomfort swallowing capsule, issues regarding video capture, issues regarding video 
transmission, erroneous video interpretation that has no significant impact on clinical care, 
protocol deviations, reactions to medication (pro-motility agent), delays in endoscopy 
interpretation, delays in EGD and others.  All minor adverse events will be shared with the entire 
research team at regularly scheduled monthly calls or sooner at the PI’s discretion.    
Any major adverse events that occur will be reported directly to the principal investigator who 
will be available to study subjects 24 hours a day. Severe adverse events will be reported to the 
entire research team, the DSMB and to IRB within 24 hours. Updates will be provided after a full 
investigation is completed.  Since the PillCam is an FDA-approved device and not an 
experimental device, all SAE’s will also be reported to the FDA. Potential major adverse events 
include missed high-risk lesions, delayed definitive care, patients who are discharged from 
hospital and experience a major outcome (see below), capsule retention in the small bowel, and 
any serious outcome that may be related to study protocol.  A DSMB will be formed that 
includes experts in emergency medicine, gastroenterology and research methodology.  DSMB 
will meet annually during which a report will be produced by PI and as needed for SAE’s.   
2.3.2 
Potential Benefits 
Immediate potential benefits include a focused effort by the research team to ensure that an 
EGD is performed within 24 hours of ED presentation for all subjects who are admitted and 
within 72 hours for all subjects who are discharged from the ED.  In addition, some subjects 
may avoid hospitalization and have their symptoms managed as an outpatient. Long-term 
potential benefits include better management of a condition that is common and can recur. 
2.3.3 Discussion  
The typical primary care, urgent care or emergency care provider is unable to evaluate common 
and serious conditions of the gastrointestinal tract such as a bleeding peptic ulcer. As such, 
more than 80% of patients who present to US ED’s with suspected bleeding in their upper GI 
tract require hospitalization, procedural sedation by an anesthesiologist, and a traditional tube-
based upper endoscopy by a gastroenterologist. While this traditional process is safe and 
effective, it is not efficient for low-risk patients and not timely for all high-risk patients. The 
opportunity to bring VCE to the front-lines of US medical care will revolutionize how we manage 
upper GI bleeding and shed light on critical diseases that have heretofore been hidden from 
providers.   This trial is an important step toward demonstrating that VCE is a safe and effective 
tool to risk-stratify upper GI bleeding and improve quality of emergency care for all patients.   

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3 OBJECTIVES 
3.1 
Study Objectives 
 
Our primary goal is to test whether ED Video Capsule Endoscopy (VCE) is able to safely 
discharge low risk patients for outpatient evaluation and management.  Our secondary objective 
is to estimate the sensitivity and specificity of VCE compared to subsequent EGD in the 
detection of serious bleeding lesions in the upper gastrointestinal (GI) tract. 
3.2 
Study Outcome Measures 
3.2.1 Primary Outcome: (1) Percent Discharged Home. Assumption is that 100% of Active 
Control (AC) group will be admitted. 
3.2.2 Secondary Outcome: Sensitivity and specificity of VCE compared to EGD. Endpoints will 
be defined in the following way: 
 
Positive Video Capsule Endoscopy will be defined as:  
1. 
Fresh blood or evidence of active bleeding visualized in upper GI tract.  
2. 
Coffee ground blood visualized in upper GI tract, but no active bleeding seen.  
3.      A High Grade Non-Variceal Lesion (Forrest Ia, Ib, IIa or IIb). 
4.      Signs of Variceal Hemorrhage. 
5.  
Signs of malignancy visualized in upper GI tract. 
 
Negative VCE: 
5. 
Clean stomach and duodenum, no fresh blood or coffee ground.  
6. 
Upper GI pathology non-causative/ incidental.  
7.      A low grade non-Variceal lesion (Forrest IIc, III). 
 
An Inconclusive VCE:   
8.        Any capsule that does not pass the pylorus before battery life is expired (and does not 
detect lesion in stomach or esophagus). 
 
Positive EGD 
1. 
Fresh blood or evidence of active bleeding.  
2. 
Coffee ground but no active bleeding seen.  
3.      A High Grade Non-Variceal Lesion (Forrest Ia, Ib, IIa or IIb). 
4.     Signs of Variceal Hemorrhage. 
 
Negative EGD 
5. 
Clean stomach and duodenum, no fresh blood or coffee ground.  
6.      Upper GI pathology non-causative/ incidental.  
7.      A low grade non-variceal lesion (Forrest IIc, III). 
 
Other Outcomes: 
1. Patient satisfaction with the VCE procedure. (Form Used: CHEER #4) 

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2. GI Physician Final Read and Site physician agreement of VCE results. (Form Used: CHEER 
#5) 
3. Serious Adverse Events at Day 7 and Day 30 (Mortality, Re-Bleeding, Total Blood 
Transfusions, Surgery, Capsule-specific). (Form Used: CHEER #7) 
4. ED Length of Stay (hours). 
5. Hospital Length of Stay (days). 
6. Cost-effective analysis.  
o At conclusion of study, we will construct a model using standard decision 
analysis software to examine the cost-effectiveness of three available strategies 
for a base-case patient who presents to the ED with either mild or moderate risk 
scenarios (by Glasgow-Blatchford Score) for requiring invasive hemostatic 
intervention (i.e., endoscopic, surgical, etc.) The three available diagnostic 
strategies are (1) direct imaging with video capsule endoscopy performed in the 
ED, (2) risk stratification using the Glasgow-Blatchford score, and, finally, (3) an 
admit-all strategy.   
 
  
 

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4 STUDY DESIGN 
4.1 
Study Design: Randomized Controlled Trial   
 
4.2 
Proposed Sites:  GWU, Temple, Duke and other additional sites TBD.  
 
4.3 
Patient Safety: The study will be conducted in compliance with Declaration of Helsinki 
and ICH-GCP guidelines. Study design will be vetted by the local IRB at each participating 
institution prior to commencement. 
 
4.4 
Study procedure: 
1. Screen potential patients with signs of upper GI bleeding (melena, h/o hematemesis or 
coffee-ground emesis) from general pool of ED patients. (Form used, CHEER:1)  
 
2. Patients who screen as eligible will be approached about potential interest, to review of 
inclusion and exclusion criteria, and obtain informed consent. (See below for full list of 
inclusion/ exclusion criteria.) 
 
3. Research Coordinator will calculate traditional risk stratification scores (Glasgow –
Blatchford and Rockall). 
 
4. All consented patients will be given a study ID and recorded in enrollment log. (Form 
used, CHEER:2) 
 
5. Once enrolled, all subjects will be randomized to either Active Control (AC) [admission 
plus EGD within hospital stay] or experimental Capsule Endoscopy Risk Assessment 
(CERA) in ED.   
 
6. Only patients randomized to the experimental arm will receive video capsule endoscopy 
in the emergency department. 20 to 60 minutes before capsule ingestion, each patient in 
the experimental arm receives a single dose of intravenous metoclopramide 10 mg (or 
erythromycin 500mg intravenously if there is a contraindication), which helps to promote 
gastric motility and improves visualization of the gastric mucosa at endoscopy.  The 
Research Coordinator (RC) will prepare the patient for VCE. (See below for description 
of procedure.)   
 
7. Within 2 hours of presenting to the ED, patient will ingest video capsule-- RC will monitor 
progress on real-time viewer for passage through pylorus. Upon passing the pylorus, we 
will record 5 more minutes of video or until battery runs out – whichever occurs first.  
 
8. Patient data will be completed using a standardized data collection tool including the 
following elements: chief complaint of patient, history of present illness, past medical 
history, pertinent lab findings, current medications, vital signs, focused physical exam 
findings and all relevant treatments administered during the ED and hospital stay. (Form 
Used, CHEER:3) 
 
 

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9. At completion of VCE, patient satisfaction regarding VCE will be assessed in patients in 
the experimental group. (Form used, CHEER: 4) 
 
10. For Active Control (AC) group each patient will be admitted.    
 
During hospital admission, EGD will be performed on all subjects and hemostasis 
therapy applied as necessary.  The study team decided against mandating that EGD be 
performed within 24 hours of hospital admission. This is a pragmatic trial.  The longer 
the duration between the inpatient EGD and the ED VCE the greater the likelihood of 
discrepancy in the findings that may be due to a change in the lesion as part of its 
natural course or due to treatments delivered. However, the primary objective of the 
study is not to evaluate diagnostic accuracy of the ED VCE.  The study team decided it 
was more important to enroll subjects in a timely manner than exclude subjects because 
the inpatient EGD was not completed within 24 hours.   
 
For the experimental CERA group, subjects will be monitored for a minimum of 4 hours 
after ingestion. VCE will be undergo a formal review after completion of the VCE by a 
staff gastroenterologist with extensive experience in VCEs of the small bowel, colon, and 
esophagus. Both research personnel and the gastroenterologist will undergo a capsule 
training program organized by Medtronic and receive accreditation after the training. 
 
11. Subjects in the experimental arm who have no sign of active bleeding, show no serious 
endoscopic findings on capsule, and have stable hemoglobin, blood pressure and heart 
rate for at least 4 hours will be discharged from the ED. Discharged CE patients will be 
scheduled to have an outpatient EGD within 3 days post discharge. Patients will be 
instructed to return to the ED sooner if signs of new bleeding develops. The Research 
Coordinator will facilitate setting up this appointment for the patient.  
 
Any subject in the experimental arm with a positive VCE or a negative VCE but has a 
drop in Hemoglobin ≥ 3 at 4 hours or an elevated HR or low BP will be admitted. A 
hemoglobin drop between 2 and 3 will NOT automatically transfer patient to active 
control arm. In these cases, decision to proceed will be up to discretion of treating 
physician.  We anticipate that all admitted patients in the experimental arm will undergo 
EGD in the hospital (same as AC arm.) 
 
12. Primary Outcome: (1) Percent Discharged Home. Assumption is that 100% of Active 
Control / standard risk assessment will be admitted. 
 
13. Secondary Outcome: Sensitivity and specificity of VCE compared to EGD 
 
14. Safety outcomes. Patient will be followed for clinical course and EGD results. Day 7 and 
Day 30, subject follow-up by telephone (if home) or in person (if still in hospital) to 
assess for adverse events or recurrent bleeding episode.  (Form Used, CHEER: 6,7) 
 
15. All VCE’s will be re-read by offsite gastroenterologists who are blinded to the first 
interpretation and the patient. 

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5 STUDY ENROLLMENT AND WITHDRAWAL 
5.1 
Subject Inclusion Criteria 
Individuals aged ≥ 18 years presenting to the Emergency Department with “likely upper GI 
bleed” (typically bloody emesis and/or coffee ground vomiting and/or melena) that has occurred 
within the previous 48 hours. 
 
5.2 
Subject Exclusion Criteria 
 
1. Upper GI Bleed with hemodynamic instability (BP<90 mmHg, pulse>120 beats per minute, 
and Hgb < 9 g/dL) 
2. High Risk Upper GI Bleed (Glasgow Blatchford Score* ≥ 6) 
3. Signs, symptoms or history of liver cirrhosis or liver failure 
4. Signs, symptoms or history of decompensated heart failure or congestive heart failure 
5. Presumed Pregnant, trying to conceive or breastfeeding  
6. Known history of gastric cancer 
7. Known history of gastric or esophageal varices 
8. GI surgery within the last 6 months 
9. Prior enrollment in the CHEER Study  
10. Prisoner or Ward of State 
11. Trouble swallowing, suspected bowel obstruction or perforation, per treating clinician 
12. Past UGI tract surgery (e.g., Bilroth I or II, esophagectomy, gastrectomy, bariatric 
procedure) that changes Gastrointestinal anatomy  
13. Known history of gastroparesis, esophageal stricture or Crohn’s disease  
14. Altered mental status that limits the ability to swallow a capsule 
15. Expected to have Magnetic Resonance Imaging (MRI) examination within 7 days 
16. Consumed medications within the past 12 hours that may coat the upper GI tract such as 
antacids or sucralfate or Maalox and potentially limits capsule visualization 
17. Patient either refuses or is unable to get traditional EGD  
18. Patient does not have reliable contact information – no phone, no permanent address 
19. Patient refuses  
20. Unable to provide written consent 
21. Non-English speaker 
22. Suspected middle or lower GI bleeding 
23. Treating ED Physician is not amenable to admission or discharge based on randomization 
or Video Capsule Endoscopy results.  
* As a modification, the GBS Score modified from the traditional GBS score to reduce the 
Hemoglobin cut-off for 6 points from 10g/dL to 9 g/dL (see Appendix B, CHEER 4; patient 
screening) 
5.3 
Strategies for Recruitment and Retention 
Patients will be screened and recruited through the Emergency Department.  Research 
assistants will be monitoring chief complaints and then reviewing the patient record, interview 
with provider and patients for inclusion and exclusion criteria.  

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5.4 
Subject Withdrawal 
5.4.1 
Reasons for Withdrawal 
A subject can withdraw at any time and for any reason.  Subject should provide written notice to 
PI as to withdrawal intent.  The PI can withdraw a patient from the study for noncompliance 
issues or serious medical conflicts.   
5.4.2 
Handling of Subject Withdrawals 
If subject withdraws from the study, no further contact will be attempted or made by study staff.  
If patient is withdrawn from study by PI for non-compliance or health related concerns, study 
staff will notify subject via phone call and/or IRB approved letter if direct contact cannot be 
made.   
5.5 
Premature Termination or Suspension of Study 
Notification of all study subjects. No further data collection. 
 
 

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6 STUDY TIMETABLE 
6.1 
Timeline 
 
 
 
 
 
 
 
 
 
 
 
 
December 2016 through April 2018 will be used for preparing and finalizing protocol, 
source documents and preparing submission for the IRB. 
During this time, we will also:   
• create the real time read group  
• create training plan 
• finalize DSMB members  
6.2 
Data Collection Period 
April 2018- April 2019 will begin screening and recruitment.  PI will travel to sites to 
ensure consistency with using source documents, data base entry and reading results 
from PillCam 
6.3 
Final Analysis  
April 2019-November 2019 will be for data cleaning, data analysis and manuscript 
preparation and submittal.   
 
 
Close out/Final 
Analysis 
1/16 
   4/18 
 
  
 
  
 
  
 
4/19 
 
10/19 
Recruitment & Follow-up  
Preparation 
Data processing   

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7 STUDY PROCEDURES 
7.1 
Screening and Randomization  
Potential study subjects will be identified while present in the Emergency Department.  While 
the patient is in the ED, a member of the research team will be notified.  This researcher will 
determine if the patient meets the inclusion and exclusion criteria.  If the patient meets 
enrollment criteria, the study protocol will be explained to the patient.  If they express interest in 
participation, informed consent will be obtained, randomization will take place, study procedures 
followed, and follow-up with GI for EGD will be arranged before the patient is discharged from 
the ED. 
7.2 
Procedural Treatment Protocol 
7.3 
Study Outcomes 
7.3.1 
Primary Outcomes 
Our primary goal is to test whether ED Video Capsule Endoscopy (VCE) is able to 
safely discharge low risk patients for outpatient evaluation and management.   
7.3.2 
Secondary Outcomes 
Our secondary objective is to estimate the sensitivity and specificity of VCE compared 
to subsequent EGD in the detection of serious bleeding lesions in the upper 
gastrointestinal (GI) tract. 
7.4 
Baseline Procedures  
In this randomized clinical trial, the following data and procedures will be performed at 
screening: 
• 
Informed consent  
• 
Eligibility  
• 
Medical history  
• 
Physical exam  
• 
Medications 
• 
Labs  
7.5 
Patient Management and Follow-up 
After randomization, patients are contacted on days 7 and 30.  All the interventions and 
clinical follow-up in this study are those normally performed in the treatment of patients 
diagnosed with Upper GI Bleed.  The only treatments that are not routine are the VCE 
PillCam event, read and subsequent discharge to home. Follow–up data will be 
collected in one of three ways:  telephone follow-up is the most preferred method, but 
email communication or texting to the patient’s cell-phone can also be used, in the case 
that a telephone call is not feasible. 

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7.6 
Adverse Event Reporting  
Detailed information concerning adverse events will be collected and evaluated throughout the 
conduct of the protocol.  Results of clinical observations, laboratory tests, and reported events 
form the basis for evaluating the safety profile of this therapy.  At all contacts, patients will be 
questioned regarding side effects or symptoms associated with the study medication which are 
as follows: 
 
• 
Difficulty swallowing the PillCam UGI  
• 
Capsule stuck in the stomach or bowel  
• 
Inability to pass PillCam naturally through a bowel movement  
• 
Surgical intervention  
• 
Aspiration  
• 
Possible skin irritation from the sensors 
 
The clinical center will report adverse events to the coordinating center in a timely fashion.  The 
coordinating center will summarize and report adverse events to the DSMB.   
Additional procedures are warranted for cases of serious adverse events which is defined by the 
FDA as a patient outcome that is:  (1) death; (2) life-threatening, i.e., the patient was at 
substantial risk of dying at the time of the adverse event or it is suspected that the use or 
continued use of the product would result in the patient's death; (3) hospitalization (initial or 
prolonged); (4) disability, i.e., resulted in a significant, persistent, or permanent change, 
impairment, damage or disruption in the patient's body function/structure, physical activities or 
quality of life; (5) congenital anomaly, i.e., there are suspicions that exposure to a medical 
product prior to conception or during pregnancy resulted in an adverse outcome in the child; (6) 
requires intervention to prevent permanent impairment or damage.  Serious adverse events will 
be reported immediately to the Study PI, site PI and the local IRB.  The PI will notify the DSMB.  
The only indication for breaking the randomization code is when it is medically necessary to 
unmask the study drug assignment to be able to treat the patient, such as an allergic reaction or 
severe side effect that appears to be related to the medication.

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8 QUESTIONNAIRE ADMINISTRATION 
Data will be collected on standardized forms on which nearly all responses have been pre-
coded. Each form is briefly described below:  
 
8.1 
Cheer 1: Screening Log 
Screening Log lists all patients screened for the study and some demographic data. 
8.2 
Cheer 2: Eligibility and Randomization Form  
Eligibility and randomization form will collect the specific inclusion and exclusion criteria 
for study consent and participation.  
Affix randomization label on this form. 
8.3 
Cheer 3: Patient Data Collection Form  
Patient data collection form is completed for all randomized patients. This form includes 
detailed medical data obtained during screening for the study.  
8.4 
Cheer 4:  Video Capsule Endoscopy Data 
Collection sheet 
This form is completed by the Gastroenterologist completed the VCE read.  
8.5 
Cheer 5: EGD Data Collection Sheet 
This form is completed by the Gastroenterologist completing the EGD read 
Interpretation Form.  
8.6 
Cheer 6: Patient Satisfaction 
This form is completed during the day 7 and day 30 follow up contact. 
8.7 
Cheer 7: Patient Follow up 
This form is completed during the day 7 and day 30 follow up contact, please verify 
information via EHR if necessary.  
8.8 
Cheer 8: Hospitalization Course/ Chart Review 
This form collects information on the hospitalization and procedures during the patient’s 
hospital stay.   

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8.9 
Cheer 9:  Adverse Event Form/ Serious Event 
From 
This form is completed if patient reports any AE or SAE’s. Report to PI within 24 hours, 
SAE’s are reported immediately.  
8.10:          Cheer 10: Protocol Deviation  
This form is completed if there is a deviation from the protocol at any time during the 
patient’s course of participating in the study. 

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9 WEB DATA ENTRY SYSTEM  
For this protocol, web data entry screens corresponding to the study forms listed above will be 
developed and maintained by GWU. Clinical center staff will enter data into the RedCap 
database for de-identified data.  GWU is no longer able to maintain identifying information in 
RedCap.  
Each site will maintain their own record keeping for maintaining their source documentation for 
patient information pertaining to follow up contact and file collection of physical source 
documentation.  Please follow your institutional IRB for record maintenance.   

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10 ASSESSMENT OF SAFETY 
10.1 
Unanticipated Problems  
10.1.1 Capsule Retention, Capsule Retention, Group Crossover 
10.2 
Serious Adverse Events  
 
Serious adverse events will be reported immediately to the Study PI and the local IRB.  
Additional procedures are warranted for cases of serious adverse events which is defined by the 
FDA as a patient outcome that is:  
 
(1) Death;  
(2) Life-threatening, i.e., the patient was at substantial risk of dying at the time of the 
adverse event or it is suspected that the use or continued use of the product would result 
in the patient's death;  
(3) Hospitalization (initial or prolonged);  
(4) Disability, i.e., resulted in a significant, persistent, or permanent change, impairment, 
damage or disruption in the patient's body function/structure, physical activities or quality 
of life;  
(5) Congenital anomaly, i.e., there are suspicions that exposure to a medical product prior to 
conception or during pregnancy resulted in an adverse outcome in the child;  
(6) Requires intervention to prevent permanent impairment or damage.  
 
If a patient in either group experiences any of the aforementioned six outcomes that may be 
possibly related to the research protocol, including but not limited to the following categories of 
risk:  
(1) Missed gastrointestinal lesion;  
(2) Capsule ingestion;  
(3) Capsule retention;  
(4) Delayed definitive care;  
10.3 
Reporting Procedures 
All adverse events get reported to site IRB, to study PI and DSMB. 

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11 HYPOTHESIS AND ANALYSIS 
11.1 
Study Hypotheses 
We hypothesize that there will be no significant difference in the hospital admission rate among 
subjects diagnosed with a high-risk lesion between the two study groups whereas there will be a 
significant difference in the hospital admission rate among subjects with a low risk lesion.   
11.2 
Sample Size Considerations 
With 100 patients, we will have adequate power (i.e. ≥ 80%) to detect a 25% difference or 
greater in admission rates for subjects with low risk lesions with p- value less than 0.05.  We 
assume that the controls will a 100% admission rate.  We anticipate 20% or less of all subjects 
to be diagnosed with a high-risk lesion, we are unlikely to have adequate power to detect a 
significant difference in the hospital admission rate between the two study groups.   
11.3 
Final Analysis Plan 
The analysis will be conducted in several stages.  First, we will compare the baseline 
characteristics of the two study groups to determine if randomization was successful.  We will 
also compare the baseline characteristics of the study samples by enrollment site.  Second, we 
will compare the VCE and EGD results and classify all study subjects according to whether 
there is a high versus low risk lesion present.  The VCE and EGD results may differ because 
they are not being performed at the same time and GI bleeds can resolve or change so it is 
unlikely that there will be perfect agreement between the two modalities.  In cases where one 
modality identifies a low risk lesion and the other one a high-risk lesion, we will classify the 
lesion as high risk.  If the VCE could not adequately visualize the tract, we will classify the 
results according to the EGD.  We will compare the sensitivity and specificity of VCE and EGD 
for identifying high risk lesions. Finally, we will separately compare the admission rates of high-
risk lesions and low risk lesions between the two study groups.  We will compare admission 
rates aggregated across the four study centers as well as within each study center.  
For tertiary outcomes, we will compare the outcomes by study group using a chi-square test 
statistic if the outcome is categorical such as the presence of an adverse event and a t test 
(normally distributed) or median test (non-normally distributed) if the outcome is continuous 
such as hospital or ED length of stay.   
11.4 
Cost-Effective Analysis  
 
A cost-effective model will be constructed to determine if the increased upfront cost of VCE is 
offset by the decreased cost due to fewer admissions.   
 

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12 STUDY OVERSIGHT 
A Data Safety Monitoring Board (DSMB) consisting of appropriately qualified independent 
experts has been appointed by the PI to provide review of data on patient safety and study 
progress. The membership roster is maintained by Site PI and study coordinator and is 
available from them as needed. PI will provide reports including adverse events. A summary of 
DSMB deliberations will be prepared distributed to the subsites to submit to their IRB. 
The Data and Safety Monitoring Board provides ongoing evaluation of the study progress 
including patient accrual and retention, monitoring of adverse events, and the adequacy and 
efficiency of the analysis plan to discern outcomes that might require study modifications, or 
result in early cessation of the study due to its benefits or harms. The DSMB does not evaluate 
the scientific merit or methodology of the study, nor does it directly participate in the execution 
of a study’s protocol, monitor the budget, or approve sub-protocols or other modifications to the 
study.  
 
The major responsibilities of the Board are:  
 
• 
To review the data analysis plan and make recommendations for additions or changes to 
the plan.  
 
• 
To assess the performance of each participating center and make appropriate 
recommendations regarding continuation, probationary status, or termination.  
 
• 
To consider patient accrual, overall study progress (timeline and follow-up participation), 
adverse effects and patient safety, treatment effectiveness/futility, and proper monitoring 
and reporting by the study team as these affect the ethical treatment of participants or 
the ethical conduct of research.  
 
• 
Report to the PI on any perceived problems with study conduct, enrollment, sample size, 
and data collection.  
 
12.1 
 Site Visits 
PI and study coordinator will visit all sites a minimum of once annually and each site will engage 
in monthly calls.   
12.2 
Monthly Reports 
Monthly Recruitment Reports - reports of the number of people screened and enrolled by 
month. Reports detailing recruitment, baseline patient characteristics, data quality, incidence of 
missing data and adherence to study protocol. 
12.3 
Annual Reports 
Data and Safety Monitoring Board (DSMB) Reports - The DSMB will prepare a written report 
which includes patient recruitment, baseline patient characteristics, center performance 
information with respect to data quality, timeliness of data submission and protocol adherence 
(in addition to safety and efficacy data). The reports also include adverse events, loss to follow-
up and all outcome variables as described previously in this protocol.  

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13 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Study staff will maintain appropriate medical and research records for this study, in compliance 
with ICH E6, Section 4.9 and regulatory and institutional requirements for the protection of 
confidentiality of subjects.   
 

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14 QUALITY CONTROL AND QUALITY ASSURANCE 
QC procedures will be implemented beginning with the data entry system and data QC checks 
that will be run on the database will be generated. Any missing data or data anomalies will be 
communicated to the site(s) for clarification/resolution. 
Following written SOPs, the monitors will verify that the clinical trial is conducted, and data are 
generated, documented (recorded), and reported in compliance with the protocol, GCP, and the 
applicable regulatory requirements (e.g., Good Laboratory Practices (GLP), Good 
Manufacturing Practices (GMP)). 
The investigational site will provide direct access to all trial related sites, source 
data/documents, and reports for the purpose of monitoring and auditing by the sponsor, and 
inspection by local and regulatory authorities. 
 

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15 ETHICS/PROTECTION OF HUMAN SUBJECTS 
15.1 
Good Clinical Practices 
The investigator will ensure that this study is conducted in full conformity with the principles set 
forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human 
Subjects of Research, as drafted by the US National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 
46 and/or the ICH E6.   
15.2 
Institutional Review Board 
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 in the study.   
15.3 
Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to participate in the 
study and continues throughout study participation.  Extensive discussion of risks and possible 
benefits of study participation will be provided to participants and their families, if applicable.  A 
consent form describing in detail the study procedures and risks will be given to the participant.  
Consent forms will be IRB-approved, and the participant is required to read and review the 
document or have the document read to him or her.  The investigator or designee will explain 
the research study to the participant and answer any questions that may arise.  The participant 
will sign the informed consent document prior to any study-related assessments or procedures.  
Participants will be given the opportunity to discuss the study with their surrogates or think about 
it prior to agreeing to participate.  They may withdraw consent at any time throughout the course 
of the study.  A copy of the signed informed consent document will be given to participants for 
their records.  The rights and welfare of the participants will be protected by emphasizing to 
them that the quality of their clinical care will not be adversely affected if they decline to 
participate in this study. The consent process will be documented in the clinical or research 
record.   
15.4 
Exclusion of Women, Minorities, and Children 
(Special Populations) 
All adults will be included. Children will be excluded because upper GI bleed is typically a 
disease of adults. 
15.5 
Participant Confidentiality 
All records will be confidential.  Subjects will not be identified in any reports or publications of 
this study.  It is possible that representatives of regulatory agencies and from the study’s 
sponsor may come to (the university/hospital) to review study information.  In that situation, 
copies of the relevant parts of the study records will be released with all identifying information 
removed.  Access to study records will be limited to those who need the information for 
purposes of this study, as well as your health care providers should they need access to the 
information.  All records are kept in a secure location and access is limited to research study 
personnel. 

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16 DATA HANDLING AND RECORD KEEPING 
 
16.1 
Data Management Responsibilities 
Each participating site will maintain appropriate medical and research records for this trial, in 
compliance with ICH E6 and regulatory and institutional requirements for the protection of 
confidentiality of participants. As part of participating in this study, each site will permit 
authorized representatives of the PI to examine (and when permitted by applicable law, to copy) 
clinical records for the purposes of quality assurance reviews, audits, and evaluation of the 
study safety, progress, and data validity.  
Source data are all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Examples 
include, but are not limited to, hospital records, clinical and office charts, laboratory notes, 
memoranda, recorded videos of upper Gi tract, recorded data from automated instruments, 
copies or transcriptions certified after verification as being accurate and complete, microfiches, 
photographic negatives, microfilm or magnetic media, x-rays, and participant files and records 
kept at the pharmacy, at the laboratories, and medico-technical departments involved in the 
clinical trial. It is acceptable to use CRFs as source documents. Except for videos, all data will 
be collected on CRFs.  
Study participation will also be recorded in the medical record to ensure that anyone who would 
access the patient medical record has adequate knowledge that the patient is participating in a 
clinical trial. 
 
16.2 
Data Capture Methods 
Data will be captured both via hand written source documents and a centralized web-based 
data entry system.  The centralized web system will be Redcap and will be administered by 
GWUH.  
16.3 
Schedule and Content of Reports 
The recruitment and follow-up periods begin in April 2017 and continue through April 2018. Data 
queries are generated and resolved during this time period through June 2018. Data close-out 
will be performed immediately following end of recruitment period. 
16.4 
Study Records Retention 
Study records will be maintained for at 3 years post study closure and per IRB specifications.   
16.5 
Protocol Deviations 
Protocol deviations will be maintained through protocol deviations source documentation that is 
entered into the centralized databased.  Protocol deviations will also be reported directly to 
study PI within 24 hours.   
 

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17 PUBLICATION/DATA SHARING POLICY 
This study will comply with the NIH Public Access Policy, which ensures that the public has 
access to the published results of NIH funded research. It requires scientists to submit final 
peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed 
Central upon acceptance for publication.   
 

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18 LITERATURE REFERENCES  
White CM, Kilgore ML. PillCam ESO Versus Esophagogastroduodenoscopy (EGD) in 
Esophageal Variceal Screening: A Decision Analysis. J Clin Gastroenterol. 2009 Aug 5. [Epub 
ahead of print] PubMed PMID: 19661814.  
Moglia A, Menciassi A, Dario P, Cuschieri A. Capsule endoscopy: progress update and 
challenges ahead. Nat Rev Gastroenterol Hepatol. 2009 Jun;6(6):353-62. Review. PubMed 
PMID: 19434097.  
Lapalus MG. Esophageal capsule endoscopy vs. EGD for the evaluation of portal hypertension: 
a French prospective multicenter comparative study. Am J Gastroenterol. 2009 
May;104(5):1112-8. Epub 2009 Mar 31.  
Seddighzadeh A, Wolf AT, Parasuraman S, Shetty R, Vallurupalli N, Reddy S, Goldhaber SZ. 
Gastrointestinal complications after 3 months of dual antiplatelet therapy for drug-eluting stents 
as assessed by wireless capsule endoscopy. Clin Appl Thromb Hemost. 2009 Mar-
Apr;15(2):171-6. Epub 2008 Dec 30. PubMed PMID: 19117963.  
Westerhof J, Koornstra JJ, Weersma RK. Capsule endoscopy: a review from the clinician's 
perspectives. Minerva Gastroenterol Dietol. 2008 Jun;54(2):189-207. Review. PubMed PMID: 
18319691.  
Gralnek IM, Adler SN, Yassin K, Koslowsky B, Metzger Y, Eliakim R. Detecting esophageal 
disease with second-generation capsule endoscopy: initial evaluation of the PillCam ESO 2. 
Endoscopy. 2008 Apr; 40(4):275-9. PubMed PMID: 18389444. 
[9] Sung J.J.Y., Tang R.S.Y., Ching J.Y.L., Rainer T.H., Lau J.Y.W. Use of capsule endoscopy 
in the emergency department as a triage of patients with GI bleeding.  (2016) Gastrointestinal 
Endoscopy, 84 (6), pp. 907-913. 
 
 
 
 

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APPENDICES 
18.1 
APPENDIX A: Schedule of Events 
 
2017 
December - February  Consensus building. Protocol Development 
 
2017 
January-December 
IRB submission at all sites 
January-December 
Contract between primary site GW and all enrolling sites 
January- December DSMB formation, steering committee convene, central CE reading team 
call schedule established for March 2017 to March 2018 
2018 
March  
 
CE training and Site Visit by PI and team 
April   
 
Enrollment kick off 
April-April 
   
Monthly Calls for entire team. Status reports. 
 
2019 
April 
 
 
Target Enrollment Reached, End recruitment 
April 
 
 
DSMB report prepared 
June 
 
 
Data Cleaning 
August  
 
First manuscript Draft Prepared 
September 
 
Manuscript Submitted (To be discussed: Dissemination plan.) 
 
 
 
 
 
 
 

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18.2 
APPENDIX B – Document List 
 
Cheer 1: Screening Log 
Cheer 2: Eligibility  
Cheer 3: Patient Data Collection Form  
Cheer 4: Patient Screening; GBS Score  
Cheer 5:  Patient Lab Values Pre- PillCam 
Cheer 6: Patient Lab Values Post-PillCam  
Cheer 7:  Video Capsule Endoscopy Data Collection sheet 
Cheer 8: EGD Data Collection Sheet 
Cheer 9: Patient Satisfaction Day 7 and Day 30 
Cheer 10:  Patient Follow up Day 7 and Day 30 
Cheer 11: Patient Chart Review 
Cheer 12:  Adverse Event Form/ Serious Event From 
Cheer 13: Protocol Deviation  
  

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18.3 
 Screening Log 
 

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18.4 
 Patient Screening 
Patient Screening 
Record ID ___________ Date of Screening _________________Initials of Person Completing Form________ 
 
1.Age of 18 or older  
Yes No (Must be YES to be eligible for study) 
2.Evidence of likely acute upper GI bleed (melena, hematemesis (bright red or coffee-ground) in 
the last 48 hours?  
Yes No (Must be YES to be eligible for study) 
3. Treating ED Physician is amenable to admission or discharge based on randomization and/or 
results of video capsule endoscopy.  
Yes No (Must be YES to be eligible) 
4.Upper GI Bleed with hemodynamic instability (BP<90 mmHg, pulse>120 beats per minute, and 
Hgb<9 g/dL)   
Yes No (Must be NO to be eligible for study)5. High Risk Upper GI Bleed (Glasgow Blatchford Score ≥ 
6) 
Yes No (Must be NO to be eligible for study)5. Presumed pregnant, trying to conceive or 
breastfeeding  
Yes No (Must be NO to be eligible for study) 
6. Signs, symptoms, or history of liver cirrhosis or liver failure   
Yes No (Must be NO to be eligible for study) 
7. Signs, symptoms, or history of decompensated heart failure or congestive heart failure 
Yes No (Must be NO to be eligible for study) 
8. Known history of gastric cancer  
Yes No (Must be NO to be eligible) 
9Known history of gastric of esophageal varices 
Yes No (Must be NO to be eligible for study)  
 
10. GI surgery within the last 6 months 
Yes No (Must be NO to be eligible for study) 
11. Prior enrollment in the CHEER Study  
Yes No (Must be NO to be eligible for study) 
12. Prisoner or Ward of State 
Yes No (Must be NO to be eligible for study) 
 
13. Trouble swallowing, suspected bowel obstruction or perforation, per treating clinician 

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Yes No (Must be NO to be eligible for study) 
 
14. Past UGI tract surgery (e.g., Bilroth I or II, esophagectomy, gastrectomy, bariatric procedure) 
that changes Gastrointestinal anatomy  
Yes No (Must be NO to be eligible for study) 
 
15. Known history of gastroparesis, esophageal stricture or Crohn’s disease  
Yes No (Must be NO to be eligible for study) 
 
16. Altered mental status that limits the ability to swallow a capsule 
Yes No (Must be NO to be eligible for study) 
 
17. Expected to have Magnetic Resonance Imaging (MRI) examination within 7 days 
Yes No (Must be NO to be eligible for study) 
 
18. Consumed medications within the past 12 hours that may coat the upper GI tract such as 
antacids or sucralfate or Maalox and potentially limits capsule visualization 
Yes No (Must be NO to be eligible for study) 
 
19. Patient either refuses or is unable to get traditional EGD  
Yes No (Must be NO to be eligible for study) 
 
20. Patient does not have reliable contact information – no phone, no permanent address 
Yes No (Must be NO to be eligible for study) 
 
21. Patient refuses  
Yes No (Must be NO to be eligible for study) 
 
22. Unable to provide written consent 
Yes No (Must be NO to be eligible for study) 
 
23. Non-English speaker 
Yes No (Must be NO to be eligible for study) 
 
24. Suspected milddle or lower GI bleeding 

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Yes No (Must be NO to be eligible for study) 
 
 
 
 
If eligible and consented, affix VCE label here.  
 
 
 
 

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18.5 
Patient Data Collection  
Patient Data Collection 
Initials of Person Completing Form __________________Time __________________________________ 
Gender Male Female 
Race White Black Asian Native American Other If other, please indicate 
Ethnicity (self-report) Hispanic Not Hispanic 
Date and time patient last ate __________________________________ 
Have you had any bloody or black "tar" stools in the past 24 hours? Yes No 
Have you had bloody or coffee ground vomit in past 24 hours? Yes No 
Have you felt weak or light headed in past 24 hours? Yes No 
Have you passed out or lost consciousness in the past 24 hours? Yes No 
 
How long ago did this episode of bleeding first start? 
Less than 4 hours 
Between 4 and 12 hours 
Between 12 and 24 hours 
Between 1-2 Days 
More than 2 Days 
Unsure 
Any allergies? Yes No 
Please list allergies __________________________________ 
Is patient on any current medications? Yes No 
Please list medications __________________________________ 
Currently taking Proton pump inhibitor (PPI) Antacids?  
Examples include Prilosec (omeprazole), protonix (pantoprazole), prevacid (lansoprazole), 
aciphex (raeprazole), nexium (esomeprazole)? Yes No 
 
Do you take any NSAIDS? Examples include aspirin, ibuprofen, Aleve, Advil, Motrin? Yes No 
 
Do you have any of the following medical problems?  
Heart attack OR Heart disease                       
 
Ulcer or Gastritis or Acid Reflux  
Diabetes Mellitus  
 
 
 
Hemorrhoids 
   
Cancer that spread 
 
 
 
Prior abdominal surgery OR pelvic surgery  
Kidney Failure OR on dialysis 
 
 
inflammatory bowel disease (Crohn’s OR Ulcerative Colitis) 
Previous Smoker OR Active Smoker 
 
Bowel Obstruction 
Liver Disease OR Liver Cirrhosis 
 
 
Other: _________________________________________________ 
 

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18.6 
Patient Screening:  GBS Score 
Patient Screening: GBS Score 
Gender Male Female 
Blood Urea (mg/dL) 
<18.2 (0 points) 
18.2-22.3 (2 points) 
22.4-28 (3 points) 
28-70 (4 points) 
>70 (6 points) 
Hemoglobin (g/dl)  
>13.0 (0 points for either gender) 
12.0-13.0 (1 point male 0 point female) 
9.0-12.0 (3 points male 1 point female) 
< 9.0(6 points for either gender) 
Systolic blood pressure (mmHg) 
 >110 (0 points) 
100-109 (1 point) 
90-99 (2 points) 
< 90 (3 points) 
 
Heart rate higher than 100 bpm Yes (1 point) No (0 points) 
Presentation with syncope Yes (2 points) No (0 points) 
Cardiac Disease (echocardiography evidence) Yes (2 points) No (0 points) 
Hepatic disease (chronic, acute liver disease) Yes (2 points) No (0 points) 
Presentation with melena Yes (1 point) No (0 points) 
 
GBS Score __________________________________ 
 
(NOTE: GBS <6 to be eligible for the study) 
 
 

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18.7 
Patient Lab Values Pre PillCam 
Record ID __________________________________ 
Date/Time Collected __________________________________ 
Hemoglobin ________________g/dL 
18.8 
Patient Lab Values Post PillCam 
Record ID __________________________________ 
Date/Time Collected __________________________________ 
Hemoglobin ________________g/dL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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18.9 
PillCam Data Collection  
Video capsule endoscopy (PillCam) data collection 
Date/Time PillCam given __________________________Initials person filling out form___________________ 
Provider reading PillCam ______________________________________________________________________ 
Real Time or Retrospective Read_______________________________________ 
 
ON THE ACCOMPANYING VIDEO CAPSULE ENDOSCOPY IS THERE EVIDENCE OF THE 
FOLLOWING? (Circle all that apply) 
a. Clean stomach and duodenum, i.e., no fresh blood or coffee ground 
b. Upper GI pathology non-causative/ incidental. 
c. A LOW grade non-Variceal lesion (Forrest IIc, III) 
d. A HIGH Grade Non-Variceal Lesion (Forrest Ia, Ib, IIa or IIb) 
e. Coffee ground blood  
f. Fresh blood or evidence of active bleeding 
g. Varices (either gastric or esophageal) or Variceal Hemorrhage 
h. Other sources of bleeding  
-Mallory-Weiss 
-Angiodysplasia 
-Gastritis 
-Esophagitis 
-Tumor 
i. If there is a bleeding source, where is it?  
-Esophagus 
-Stomach 
-Duodenum 
-None detected 
j. Did the capsule pass the pylorus before battery life expired (and does not detect lesion in 
stomach or  
esophagus.)   Yes No 
k. Based on your findings, would you recommend endoscopic hemostasis?  
Yes 
No 
 

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18.10 
 
EGD Data Collection 
Esophagogastroduodenoscopy (EGD) data collection 
Date and Time EGD performed _________________________ Initials person filling out form______________ 
Where was EGD performed? Inpatient   outpatient 
Provider reading EGD __________________________________ 
Rank of person performing EGD  
Attending GI 
Attending General Surgery 
GI Fellow 1st Year 
GI Fellow 2nd Year 
GI Fellow 3rd Year + 
IN THE ACCOMPANYING EGD (ENDOSCOPY), IS THERE EVIDENCE OF THE FOLLOWING? 
(Circle all that apply) 
a. Clean stomach and duodenum, i.e., no fresh blood or coffee ground 
b. Upper GI pathology non-causative/ incidental. 
c. A LOW grade non-Variceal lesion (Forrest IIc, III) 
d. A HIGH Grade Non-Variceal Lesion (Forrest Ia, Ib, IIa or IIb) 
e. Coffee ground blood 
f. Fresh blood or evidence of active bleeding. 
g. Varices (either gastric or esophageal) or Variceal Hemorrhage 
h. Other sources of bleeding 
Other sources of bleeding  
-Mallory-Weiss 
-Angiodysplasia 
-Gastritis 
-Esophagitis 
-Tumor 
i. If there is a bleeding source detected, where is it?  
Esophagus 
Stomach 
Duodenum 
None detected 
j. Did you perform endoscopic hemostasis?  
Yes  
No 
If yes, what intervention? _______________________________________ 
 

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18.11 
Patient Satisfaction Day 7 and Day 30 
Patient Satisfaction Day 7 and Day 30  
I understood the reason for the pill camera  
Strongly Agree 
Agree 
Neutral 
Disagree 
Strongly Disagree 
 
I understood the procedure for the pill camera.  
Strongly Agree 
Agree 
Neutral 
Disagree 
Strongly Disagree 
 
I felt the research team answered all my questions Yes No 
The pill camera was easy to swallow Yes No 
I would use the pill camera again Yes No 
Did you have any issues Yes No 
if Yes, what are they? __________________________________ 
 
18.12 
Patient Follow-up Telephone Call Day 7 and 
Day 30  
Patient Follow up Telephone Call Day 7 and Day 30 
Initials of person completing form __________________________________ 
You came to the ER on {date of visit} for possible bleeding.  
Are you experienced the same or similar symptoms?  Yes   No 
Please tell me what they are ________________________________ 
(If patient is continuing to have symptoms please list) 
Have you recently noticed blood in the stood? Yes   No 
Have you vomited any BRIGHT RED or COFFEE GROUND blood recently? Yes   No 
How long how has this episode of BLEEDING lasted?  
Between 1-2 days 
Between 3-4 days 

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Between 5-7 days 
Never went away 
Unsure 
Have you noticed any bloody or black tar stools in the past 24 hours? Yes No 
Have you passed out or lost consciousness in the past 24 hours? Yes No 
Have you seen a gastroenterologist since you were discharged? Yes No 
Did you have an upper endoscopy while you were in the hospital?  Yes No 
Did you have an upper endoscopy after being discharged from the hospital? Yes No 
What were the results of the endoscopy?  
Bleeding resolved 
Bleeding persisted 
New problem 
Unsure 
If patient has a new problem, please describe. __________________________________________________ 
Did you have a return visit to the hospital? Yes No 
Return date to the hospital? _______________________________________________________________ 
Which Hospital? _________________________________________________________________________ 
Where you hospitalized for recurrent bleeding? __________________________________ 
Did you have a second endoscopy? Yes No 
What were the results? _______________________________________ 
When were you discharged? __________________________________ 
18.13 
Patient Chart Review 
Patient Chart Review 
Initials of person abstracting information from chart __________________________________ 
Hospital discharge date __________________________________ 
Blood transfusion? Yes No 
Date of transfusion __________________________________ 
Number of PRBC? __________________________________ 
Additional endoscopy Yes No 
How many? __________________________________ 
Hemostatic therapy? Yes No 
Surgery? Yes No 
Date of surgery __________________________________ 
Please describe surgery. __________________________________________ 
Disposition?  

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Home 
Rehabilitation 
Nursing home 
Deceased 
Timer 
 
 
 
 
 
 
 
 
 

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18.14 
 Adverse Event Form  
Adverse Event Form  
Initials of person completing form __________________________________ 
Start Date/Time __________________________________ 
Stop Date/Time __________________________________ 
During PillCam Administration Yes No 
Post PillCam Administration Yes No 
Please describe the AE __________________________________________ 
Relationship to the Study Protocol/Procedures (Per Site PI)  
Unrelated 
Unlikely 
Possibly 
Probably 
Definite 
_________________________ 
Relationship to the PillCam (Per Site PI)  
Unrelated 
Unlikely 
Possibly 
Probably 
Definite 
_________________________ 
Primary Outcome  
Recovered/Resolved 
Under Treatment 
Change in AE/SAE Characteristic 
Sequelae 
Fatal 
Unknown 
_____________________ 
Serious Event?  Yes No  
Life Threatening? Yes No 
Required or prolonged hospitalization? Yes No 
Disability? Yes No 
Congenital Anomaly? Yes No 
Required intervention? Yes No 
Death? Yes No 
 
Was Site PI notified? Yes No 
Was the IRB notified? Yes No: If No, Why Not? _________________________________________________ 

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18.15 
Protocol Deviation  
Protocol Deviation  
Date of Event __________________________________ 
Description of the Deviation __________________________________ 
Reason for the deviation __________________________________ 
Corrective measures __________________________________ 
Was site PI notified? Yes No 
Was IRB notified? Yes No 
Why Not? __________________________________