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Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE® | Clinical Trials | Clareo Health

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

A Prospective Randomized Comparison of Colonoscopy Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®) (Endocuff) Versus a Permanently Mounted Balloon (G-EYE®)

NCT04708951•Dr. Horst Schmidt Klinik GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Yes

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)
+1 more criteria

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

Key Dates

Start Date

January 1, 2021

Primary Completion Date

October 1, 2021

Completion Date

October 15, 2021

Last Updated

October 22, 2021

Enrollment

970

ACTUAL participants

Conditions

AdenomaColorectal Cancer

Interventions

ENDOCUFF VISION® device

DEVICE

G-EYE® colonoscope

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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