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Completed

NCT Number: NCT03961893

Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas

Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.

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Key information

Conditions

Colorectal Adenoma Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication of complete colonoscopy for classic indications (bleeding, abdominal pain, transit disorders) or for family and personal antecedents of adenomas or colorectal cancers with the need for endoscopic control,
  • FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation,
  • Consent of participation signed,
  • Affiliation to a social security scheme, or beneficiary of such a scheme.

Exclusion criteria

  • Non-optimal preparation (boston score <7 or segment <2),
  • Adenomatous polyposis, familial or assimilated (juvenile, etc.),
  • Pregnant or likely to be pregnant (without effective contraception) or breastfeeding,
  • Patient in emergency or deprived of liberty or placed under the authority of a tutor,
  • Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.

Treatment and study plan

G-EYE first and standard colonoscope

Device

Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy

standard colonoscope first and G-EYE

Device

Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)

Primary outcomes

  1. Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)

    Time frame: Colonoscopy time

    Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections

Secondary outcomes

  1. Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)

    Time frame: Colonoscopy time

    Rate between the number of advanced adenomas detected by the second examination and the number of advanced adenomas detected by the two inspections

  2. Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female

    Time frame: Colonoscopy time

    Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in male and female

  3. Rate of complications

    Time frame: Colonoscopy time and 1 month after

    Global and for each arm

  4. Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup

    Time frame: Colonoscopy time

    Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections in FIT+ subgroup

  5. Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup

    Time frame: Colonoscopy time

    Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in FIT+ subgroup

  6. G-EYE assistance for endoscope stabilization

    Time frame: Colonoscopy time

    Yes or no

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: G-EYE-ADR

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 23, 2019
Registry last updated
Jun 23, 2023

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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