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

Sponsor

Dr. Horst Schmidt Klinik GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT04708951

Collaborator

(none)

970

Enrollment

Locations

Arms

9.4

Actual Duration (Months)

323.3

Patients Per Site

34.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adenoma Colorectal Cancer	Device: ENDOCUFF VISION® device Device: G-EYE® colonoscope	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

970 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Oct 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ECV colonoscopy EndoCuff Vision® device (ECV)	Device: 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
Experimental: G-EYE® colonoscopy G-EYE® colonoscope (G-EYE)	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

Arm

Intervention/Treatment

Active Comparator: ECV colonoscopy

EndoCuff Vision® device (ECV)

Device: 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

Experimental: G-EYE® colonoscopy

G-EYE® colonoscope (G-EYE)

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)
Any patient condition deemed too risky for the study by the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IU Health University Hospital	Indianapolis	Indiana	United States	46202
2	NYU Langone Health	New York	New York	United States	10016
3	Helios Dr. Horst Schmidt Kliniken Wiesbaden	Wiesbaden		Germany	65199

Sponsors and Collaborators

Dr. Horst Schmidt Klinik GmbH

Investigators

Principal Investigator: Ralf Kiesslich, Prof., Helios Dr. Horst Schmidt Kliniken Wiesbaden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Dr. Ralf Kiesslich, Prof., Dr. Horst Schmidt Klinik GmbH

ClinicalTrials.gov Identifier:

NCT04708951

Other Study ID Numbers:

ENDOCUFF vs. G-EYE

First Posted:

Jan 14, 2021

Last Update Posted:

Oct 22, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Prof. Dr. Ralf Kiesslich, Prof., Dr. Horst Schmidt Klinik GmbH

Adenoma

Colorectal Cancer

Additional relevant MeSH terms:

Colorectal Neoplasms

Adenoma

Study Results

No Results Posted as of Oct 22, 2021