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

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ClinicalTrials.gov Identifier: NCT03961893
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:
compare the levels of adenomas missed by standard and G-EYE colonoscopes in patients over 50 years of age and in the subgroup of patients with a positive fecal immunochemical test.

Condition or disease Intervention/treatment Phase
Colorectal Adenoma Device: G-EYE first and standard colonoscope Device: standard colonoscope first and G-EYE Phase 2

Detailed Description:
compare the levels of adenomas missed by standard and G-EYE colonoscopes in patients over 50 years of age and in the subgroup of patients with a positive fecal immunochemical test.

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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: Diagnostic
Official Title: Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
Estimated Study Start Date : September 25, 2019
Estimated Primary Completion Date : October 25, 2021
Estimated Study Completion Date : November 30, 2021

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
two successive colonoscopies after patient approval and randomization of the order of implementation standard colonoscope first and G-EYE

Experimental: Arm B: G-EYE colonoscopy then standard colonoscopy
Arm B: G-EYE colonoscopy then standard colonoscopy
Device: G-EYE first and standard colonoscope
two successive colonoscopies after patient approval and randomization of the order of implementation G-EYE first and standard colonoscope




Primary Outcome Measures :
  1. compare the levels of adenomas missed by standard and G-EYE colonoscopes in patients over 50 years of age [ Time Frame: 1 month ]
    Adenomas missed by standard coloscopes and by colonoscopes equipped with G-EYE

  2. compare the levels of adenomas missed by standard and G-EYE colonoscopes in patients over 50 years of age in the FIT + subgroup. [ Time Frame: 1 month ]
    Adenomas missed in the FIT + subgroup by standard coloscopes and by colonoscopes equipped with G-EYE



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Age ≥ 50 years,
  2. Indication of complete colonoscopy for classic indications (bleeding, abdominal pain, transit disorders),
  3. Family and personal antecedents of adenomas or colorectal cancers with the need for endoscopic control,
  4. FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation,
  5. Consent of participation signed,
  6. 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. Person in emergency, person of legal age subject to a measure of legal protection (major under guardianship, guardianship or court bail), or unable to express consent,
  5. Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons.

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
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Contact: Dominique GENRE, MD 33491223778 DRCI.up@ipc.unicancer.fr

Locations
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France
Institut Paoli Calmettes Not yet 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
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Principal Investigator: Jean-Philippe RATONE, MD Institut Paoli-Calmettes

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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03961893     History of Changes
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: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Institut Paoli-Calmettes:
colonoscopy
g-eye
adenomas

Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms