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OpenTrials
Completed

NCT Number: NCT04708951

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision®

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr. Horst Schmidt Klinik GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2021
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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