Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas (G-EYE-ADR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03961893
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Adenoma Device: G-EYE first and standard colonoscope Device: standard colonoscope first and G-EYE Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, single-phase, two-stage, randomized phase II study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : February 21, 2022
Estimated Study Completion Date : February 21, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Arm A: Standard colonoscopy then colonoscopy with G-EYE
Arm A: Standard colonoscopy then colonoscopy with G-EYE
Device: standard colonoscope first and G-EYE
Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)

Experimental: Arm B: G-EYE colonoscopy then standard colonoscopy
Arm B: G-EYE colonoscopy then standard colonoscopy
Device: G-EYE first and standard colonoscope
Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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,
  2. FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation,
  3. Consent of participation signed,
  4. Affiliation to a social security scheme, or beneficiary of such a scheme.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961893


Contacts
Layout table for location contacts
Contact: Dominique GENRE, MD 33491223778 DRCI.up@ipc.unicancer.fr

Locations
Layout table for location information
France
Institut Paoli Calmettes Recruiting
Marseille, Bouches Du Rhone, France, 13009
Contact: Dominique Genre, MD    0033491223778    drci.up@ipc.unicancer.fr   
Principal Investigator: Jean-Philippe RATONE, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Layout table for investigator information
Principal Investigator: Jean-Philippe RATONE, MD Institut Paoli-Calmettes

Layout table for additonal information
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03961893    
Other Study ID Numbers: G-EYE-ADR-IPC 2016-023
2018-A03292-53 ( Other Identifier: ANSM )
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Institut Paoli-Calmettes:
colonoscopy
g-eye
adenomas
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms