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

NCT04708951 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 970

Last updated 2021-10-22

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Dr. Horst Schmidt Klinik GmbH

    lead INDUSTRY

Principal Investigators

  • Ralf Kiesslich, Prof. · Helios Dr. Horst Schmidt Kliniken Wiesbaden

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-10-01
Completion
2021-10-15
FDA Device
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04708951 on ClinicalTrials.gov