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

NCT ID: NCT04708951

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

970 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-10-15

Brief Summary

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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

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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.

Conditions

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Adenoma Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized to one of two groups - ECV colonoscopy or G-EYE® colonoscopy
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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ECV colonoscopy

EndoCuff Vision® device (ECV)

Group Type ACTIVE_COMPARATOR

ENDOCUFF VISION® device

Intervention Type DEVICE

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® colonoscopy

G-EYE® colonoscope (G-EYE)

Group Type EXPERIMENTAL

G-EYE® colonoscope

Intervention Type DEVICE

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

Interventions

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ENDOCUFF VISION® device

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

Intervention Type DEVICE

G-EYE® colonoscope

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Horst Schmidt Klinik GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Prof. Dr. Ralf Kiesslich

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralf Kiesslich, Prof.

Role: PRINCIPAL_INVESTIGATOR

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Locations

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IU Health University Hospital

Indianapolis, Indiana, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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ENDOCUFF vs. G-EYE

Identifier Type: -

Identifier Source: org_study_id