Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times
Phase: NA
Conditions: Colorectal Polyp, Colorectal Adenoma, Colon Cancer
Sponsor: Indiana University

05/10/18 
 
 
 
 
 
 
Prospective Randomized controlled trial of High-Definition White-
light colonoscopy versus High-Definition White-light colonoscopy 
with Endocuff Vision for endpoints of procedural times 
 
NCT03361917 

 
 
Prospective Randomized controlled trial of High-Definition White-
light colonoscopy versus High-Definition White-light colonoscopy 
with Endocuff Vision for endpoints of procedural times 
 
 
Primary Investigator: 
 
 
Dr. Douglas Rex, 
Indiana University Hospital 
Indianapolis, IN 46202 
 
 
Introduction: 
Endocuff Vision ( Olympus) is a disposable device that has 8 independently moving soft 
flexible arms arranged in a single row. The device comes in several sizes and can fit the tips of 
most commonly used colonoscopes. During intubation, the arms fall flat to the body of the 
scope as not to impede forward motion. Endocuff Vision is an FDA approved device that fits 
over the end of a colonoscope and has flexible soft fingers that project from the sides.  These 
fingers can be used to pull back the folds in the colon and expose mucosa on the proximal 
sides.  A number of studies indicate that Endocuff improves the adenoma detection rate 
(ADR) during colonoscopy.  In a non-randomized retrospective evaluation, Endocuff resulted 
in better detection, faster insertion, and faster inspection (1).  
 
Our aim in this study is to show in a prospective randomized trial Endocuff Vision could 
improve insertion because during loop withdrawal the cuff tends to stabilize the position of the 
tip, preventing its backward movement and speeding loop removal.  Similarly, during inspection, 
the main goal is to evaluate the proximal sides of folds and flexures.  The process is made easier 
and quicker by the device. Third, during polypectomy, Endocuff Vision helps to stabilize the 
position and the scope tip.   
 
Methods:  
This will be a prospective, randomized controlled study.  Subjects referred for screening or 
surveillance colonoscopy will be prospectively enrolled. They will be randomized to one of 
two arms, i.e High Definition colonoscopy or High Definition colonoscopy with Endocuff 
Vision. 
 
A member of the research team will approach a potential subject to discuss participation in the 
study, including background of the proposed study, inclusion and exclusion criteria, benefits 
and risks of the procedures and follow-up. If this is of interest to the subject, the informed 
consent form is discussed and presented. The subject must sign the consent form prior to 
enrollment. This form will have prior approval of the study site's Institutional Review Board 
(IRB). Failure to obtain informed consent renders the subject ineligible for the study 
 

 
 
 
Objectives: 
Primary objectives of the study are: 
 To compare the insertion time, inspection time, the total time per polypectomy, and the 
total procedure time during High Definition colonoscopy with Endocuff Vision versus 
standard High Definition colonoscopy. 
 
Secondary objectives: 
 
 To compare the number of adenomas detected per subject with High Definition 
Endocuff Vision compared to Standard High Definition colonoscopy. 
 
 To compare the detection rates for polyp subtypes (including advanced   adenomas, 
serrated polyps, right sided adenomas, etc) for High Definition Endocuff Vision 
compared to Standard High Definition colonoscopy. 
 
Primary End-point:  
 
 The inspection  time will be shorter because the proximal sides of the folds are more 
quickly exposed with Endocuff Vision compared to standard colonoscope alone because 
of the ability of the Endocuff Vision to stabilize the position of the colonoscope tip 
during loop withdrawal, thus preventing its backward movement and speeding loop 
removal. 
 
 
Criteria: 
All colonoscopies in the study will be performed by a qualified professional. Patients will be 40 
and older and will be randomized to receive colonoscopy with or without the Endocuff.  Data 
collected will include the type of scope used (adult versus pediatric), age, gender, indication, 
history of prior abdominal surgery and type, identification of diverticulosis classified as mild 
moderate or severe, insertion time, total procedural time, total withdrawal time, inspection time 
(withdrawal time minus anytime suctioning, cleaning, and diagnostic biopsy or therapeutic 
procedure), and polypectomy time for each polyp removed. For each polyp, we will record the 
location, size, shape, and pathology.  
 
Inclusion criteria 
 
• Referral for screening or surveillance colonoscopy 
• Ability to provide informed consent 
• 40 years and older 
 
Exclusion criteria 

 
 
 
• Prior history of colon cancer 
• History of inflammatory bowel disease 
• Prior surgical resection of any part of the colon 
• Use of anti-platelet agents or anticoagulants that precludes the removal of polyps 
during the procedure 
• History of polyposis syndrome or HNPCC 
• Inability to give informed consent 
• Family history of colon cancer in a first degree relative < 60 years or two first degree 
relatives with colorectal cancer 
 
 
 
Statistical Analysis and Sample Size: 
 
• Normally distributed continuous variables will be summarized using means and 
standard deviations while non-normally distributed continuous variables will be 
summarized using medians and ranges. 
 
• The primary endpoints for the study will be the inspection time and insertion time, , the 
total time per polypectomy, and the total procedure time. 
 
• 
The secondary endpoints will be total time per polypectomy, total procedure times, and adenomas 
detected. 
 
 
• All colonoscopies in the study will be performed by a qualified professional. Patients will 
be 40 and older and will be randomized to receive colonoscopy with or without the 
Endocuff.  Data collected will include the type of scope used (adult versus pediatric), age, 
gender, indication, history of prior abdominal surgery and type, identification of 
diverticulosis (classified as mild moderate or severe), insertion time, total procedural time, 
total withdrawal time, inspection time (withdrawal time minus anytime suctioning, 
cleaning, and diagnostic biopsy or therapeutic procedure), and polypectomy time for each 
polyp removed. For each polyp, we will record the location, size, shape, and pathology.  
 
There will be a sample size of 200 subjects enrolled in this study. 100 randomized into two 
groups. With the sample size of 100 per group, the study will have 80% power to detect a 1 
minute difference in the inspection time between the two groups. The inspection and insertion 
times will be compared using a two-sided two sample t-test, 5% significance level, and standard 
deviation of 2.5 minutes. 
The data will be analyzed and the statistics performed by persons in the biostatistics department.  
 

 
 
Safety Risks to the patient and Data integrity: 
All paper charts pertaining to the patient will be kept under lock and key in coordinators office 
away from the endoscopy area. The data entry will be performed into an excel file which will 
be stored on an internal network drive with encryption and password security. Data 
management will include double data entry and regular back-up of the data. Only approved 
personnel by the IRB will have access to the file storage.  This file will also not have any 
identifiable information.  A study log with the identifiable information will be kept in a 
separate folder to enable the investigators to assist in any research audit. No procedural data 
except the date of examination will be entered into this log.  
 
Any subject who wishes to withdraw from this investigation on his/her own accord and for 
whatever reason is entitled to do so without obligation and prejudice to further treatment. In 
addition, the Investigator may decide for reasons of medical prudence, to withdraw a subject. In 
either event, the Investigator will clearly document the date and reason(s) for the subject’s 
withdrawal from this investigation in the CRF and should indicate whether or not he considers it 
was related to the study interventions. 
 
References: 
(1). ZP Tsiamoulos et al. Gastrointest Endosc. 2017 Apr 13. Impact of a New Distal Attachment 
on Colonoscopy Performance in an Academic Screening Center