Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE®

Not Applicable

Completed

• Conditions: Colorectal Cancer; Adenoma

• Registration Number: NCT04708951
• Lead Sponsor: Dr. Horst Schmidt Klinik GmbH

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Status Verified: 2021-10
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-15
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 970

Inclusion Criteria

1. Screening and surveillance population for Adenoma and CRC.
2. The patient must understand and sign a written informed consent for the procedure.

Exclusion Criteria

1. Subjects with inflammatory bowel disease;
2. Subjects with a personal history of hereditary polyposis syndrome;
3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
4. Subjects with diverticulitis or toxic megacolon;
5. Subjects with prior colonic surgery (exclusion appendectomy)
6. Subjects with a history of radiation therapy to abdomen or pelvis;
7. Pregnant or lactating female subjects;
8. Subjects who are currently enrolled in another clinical investigation.
9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
11. Any patient condition deemed too risky for the study by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision®	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.

Trial Locations

Locations (3)

IU Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Helios Dr. Horst Schmidt Kliniken Wiesbaden; 🇩🇪 Wiesbaden, Germany