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

Dr. Horst Schmidt Klinik GmbH970 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

970

Conditions

Adenoma Colorectal Cancer

Interventions

ENDOCUFF VISION® deviceDEVICE

ENDOCUFF VISION® is a disposable cap placed on the tip of a standard colonoscope, intended to flatten colonic folds and assist in controlling the colonoscope's field of view and tip positioning

G-EYE® colonoscopeDEVICE

The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision®

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.

Time frame: June 2021

Data from ClinicalTrials.gov

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