Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 634
- Locations
- 2
- Primary Endpoint
- Number of Adenomas Detected Per Colonoscopy (APC).
Study Overview
Brief Summary
The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Number of Adenomas Detected Per Colonoscopy (APC).
Time Frame: During colonoscopy procedure
Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
Secondary Outcomes
- Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))(During colonoscopy procedure)
- Complications Encountered During Procedure(During Colonoscopy procedure)
- Passage of Device Through Sigmoid Colon(during insertion portion of colonoscopy)
- Polyps Per Colonoscopy (PPC)(During colonoscopy procedure)
- Time Comparison for Each Method(During colonoscopy procedure)
- Cecal Intubation Rate(During Colonoscopy procedure)
- Detection of Serrated Lesions(During colonoscopy procedure)
Investigators
Douglas K. Rex
Professor of Medicine
Indiana University