Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - Any
Updated:1/16/2019
Start Date:April 12, 2018
End Date:June 30, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.

The study aims to compare the results between colonoscopies with two different attachments on
the distal end of the colonoscope.

This will be a prospective, randomized controlled study. Subjects referred for a screening,
surveillance, or diagnostic colonoscopy will be prospectively enrolled. This study aims to
compare the number of adenomas detected per colonoscopy (APC) between an Endocuff colonoscopy
and an AmplifEYE colonoscopy.

It is estimated that the Endocuff Vision will result in an APC of 2.3. The investigators
consider that a clinically acceptable ADR for the Medivators device would be within 20% of
this value or 1.5.

Inclusion Criteria:

- 40 years of age or older

- Undergoing colonoscopy for screening, surveillance, or diagnostic purposes

- Able to provide written informed consent

Exclusion Criteria:

- Active Inflammatory Bowel Disease

- Prior resection of the colon

- Referred for resection of a polyp identified by another physician

- Referred for a previous incomplete colonoscopy
We found this trial at
1
site
Indiana University
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Douglas K Rex, MD
Phone: 317-948-0117
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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