A Prospective Randomized Comparison of Colonoscopy Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®) (Endocuff) Versus a Permanently Mounted Balloon (G-EYE®)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adenoma
- Sponsor
- Dr. Horst Schmidt Klinik GmbH
- Enrollment
- 970
- Locations
- 3
- Primary Endpoint
- Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision®
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The study is intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.
Detailed Description
This is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.
Investigators
Prof. Dr. Ralf Kiesslich
Prof.
Dr. Horst Schmidt Klinik GmbH
Eligibility Criteria
Inclusion Criteria
- •Screening and surveillance population for Adenoma and CRC.
- •The patient must understand and sign a written informed consent for the procedure.
Exclusion Criteria
- •Subjects with inflammatory bowel disease;
- •Subjects with a personal history of hereditary polyposis syndrome;
- •Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- •Subjects with diverticulitis or toxic megacolon;
- •Subjects with prior colonic surgery (exclusion appendectomy)
- •Subjects with a history of radiation therapy to abdomen or pelvis;
- •Pregnant or lactating female subjects;
- •Subjects who are currently enrolled in another clinical investigation.
- •Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
- •Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
Outcomes
Primary Outcomes
Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision®
Time Frame: June 2021
G-EYE® colonoscopy adenoma detection rate will be compared to the adenoma detection rate of EndoCuff Vision® colonoscopy. The primary performance measure is the adenoma detection rate (ADR), which is defined as the percentage of subjects with at least one adenoma found, in each of the study groups.