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出境医 / 临床实验 / Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas (G-EYE-ADR)

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

Study Description
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

Study Design
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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: 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 : March 21, 2022
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
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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. 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.
Contacts and Locations

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

Locations
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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
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Principal Investigator: Jean-Philippe RATONE, MD Institut Paoli-Calmettes
Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date May 6, 2021
Actual Study Start Date  ICMJE January 21, 2020
Estimated Primary Completion Date February 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2019) 		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
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • 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
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
  • 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
  • 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
  • Rate of complications [ Time Frame: Colonoscopy time and 1 month after ]
    Global and for each arm
  • 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
  • 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
  • G-EYE assistance for endoscope stabilization [ Time Frame: Colonoscopy time ]
    Yes or no
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
Official Title  ICMJE Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Colorectal Adenoma
Intervention  ICMJE
  • Device: G-EYE first and standard colonoscope
    Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy
  • Device: standard colonoscope first and G-EYE
    Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)
Study Arms  ICMJE
  • Experimental: Arm A: Standard colonoscopy then colonoscopy with G-EYE
    Arm A: Standard colonoscopy then colonoscopy with G-EYE
    Intervention: Device: standard colonoscope first and G-EYE
  • Experimental: Arm B: G-EYE colonoscopy then standard colonoscopy
    Arm B: G-EYE colonoscopy then standard colonoscopy
    Intervention: Device: G-EYE first and standard colonoscope
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 21, 2022
Estimated Primary Completion Date February 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dominique GENRE, MD 33491223778 DRCI.up@ipc.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961893
Other Study ID Numbers  ICMJE G-EYE-ADR-IPC 2016-023
2018-A03292-53 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut Paoli-Calmettes
Study Sponsor  ICMJE Institut Paoli-Calmettes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Philippe RATONE, MD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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