A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
NCT02345889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1262
Last updated 2019-03-12
Summary
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
Conditions
- Colorectal Neoplasms
Interventions
- DEVICE
-
Colonoscopy with EndoCuff™
colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
- DEVICE
-
FUSE® Colonoscopy
colonoscopy performed with the FUSE® (full spectrum endoscopy) system
- DEVICE
-
Colonoscopy with EndoRings™
colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
- DEVICE
-
Standard Colonoscopy
Current standard of care colonoscopy
Sponsors & Collaborators
-
Indiana University
lead OTHER
Principal Investigators
-
Douglas Rex, MD · Indiana University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-02-28
- Primary Completion
- 2017-12-31
- Completion
- 2017-12-31
Countries
- United States
Study Locations
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