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

NCT04708951 | Completed FDA Device

• 1 other identifier: ENDOCUFF vs. G-EYE
• Study Type: interventional
• Target: 970
• Locations: 2 countries
• Sites: 3

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.

Conditions

Adenoma; Colorectal Cancer

Keywords

Adenoma; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ECV colonoscopy

ACTIVE COMPARATOR

EndoCuff Vision® device (ECV)

Device: ENDOCUFF VISION® device

G-EYE® colonoscopy

EXPERIMENTAL

G-EYE® colonoscope (G-EYE)

Device: G-EYE® colonoscope

Interventions

ENDOCUFF VISION® device 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

ECV colonoscopy

G-EYE® colonoscope 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

G-EYE® colonoscopy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening and surveillance population for Adenoma and CRC.
• The patient must understand and sign a written informed consent for the procedure.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Dr. Horst Schmidt Klinik GmbH: lead

Study Sites (3)

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, 65199, Germany

Location

MeSH Terms

Conditions

Adenoma; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ralf Kiesslich, Prof.

  Helios Dr. Horst Schmidt Kliniken Wiesbaden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

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

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 14, 2021
• Study Start: January 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 15, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); DE (1)