A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy



Status:Completed
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - Any
Updated:3/14/2019
Start Date:February 2015
End Date:December 2017

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A 4-arm Randomized Controlled Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval
colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices
attached to the colonoscope tip may improve the ADR of doctors performing a screening
procedure

Recent studies indicate that continuing medical education, time of colonoscopy during the
day, forced longer withdrawal time, use of high definition colonoscopes all result in
improving ADR although the gains have only been modest. To this end, adding novel devices to
the tip of colonoscope may improve the ability of doctors to perform a better procedure. We
therefore propose to identify the increase in ADR with 3 of these devices compared to
standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip
providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible
arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the
arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss
rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually
about 40%. All these devices are FDA approved and are distributed in the United States.

Inclusion Criteria:

- Screening or Surveillance Colonoscopy

Exclusion Criteria:

- Personal history of Colorectal cancer or Inflammatory bowel disease

- Surgical resection of the colon or known colonic stricture

- Personal or family history of Polyposis syndromes or Lynch syndrome

- Referral for incomplete colonoscopy or known therapeutic polyp clearance

- Severe diverticular disease

- Referral for a positive hemoccult test in the past 6 months

- Known coagulopathy

- Inability to provide informed consent
We found this trial at
1
site
550 University Boulevard
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
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