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

Colorectal Cancer Clinical Trial

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04708951
• Other study ID #: ENDOCUFF vs. G-EYE
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: October 2021
• Source: Dr. Horst Schmidt Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 970
• Est. completion date: October 15, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Helios Dr. Horst Schmidt Kliniken Wiesbaden	Wiesbaden
United States	IU Health University Hospital	Indianapolis	Indiana
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Horst Schmidt Klinik GmbH

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	June 2021