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Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate (Cuff-Bercy)

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ClinicalTrials.gov Identifier: NCT03344055
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
KARSENTI, Société Française d'Endoscopie Digestive

Brief Summary:

This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.

This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV)


Condition or disease Intervention/treatment Phase
Colonic Adenoma Colonic Polyp Colonoscopy Device: Endocuff Vision (ECV) second generation Not Applicable

Detailed Description:

This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.

Number of patients:

2000 patients, 1000 in each group (with and without ECV). To limit the risk of bias, the investigators will random two teams of 12 endoscopists matched in number, volume of activity and Adenoma Detection Rate (evaluated over a period of the year preceding the study).

Both periods of study will be approximately 3-4 months in length. In order to achieve a perfect balance between the two groups of patients, an inclusion tracking chart will be initiate and will be carefully controlled. Rebalancing will be done for both periods of study to obtain 500 patients per group and per period (= 2000 patients included).

Inclusion of 500 consecutive colonoscopies in each team of investigators, a "colonoscopy with ECV" team, a "colonoscopy without ECV" team then switch and inclusion of 500 new consecutive colonoscopies in each team, ie 2000 colonoscopies in total.

The selection of the team that will begin with ECV (Team A) and the team that will finish with ECV (Team B) will be chosen at random before the start of the study.

A comparison of the two colonoscopy groups with ECV vs without ECV will be made for each team (the investigator will be his own control) and then on the overall population after the end of the trial.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : November 10, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: Colonoscopy with Endocuff Vision (ECV)
ECV-assisted colonoscopy ( with the use of Endocuff Vision (ECV) Second generation)
Device: Endocuff Vision (ECV) second generation
Colonoscopy performed with the use of "Endocuff Vision (ECV) second generation" at the tip of the scope

No Intervention: Standard colonoscopy
Standard colonoscopy (without the use of Endocuff Vision (ECV) Second generation)



Primary Outcome Measures :
  1. Adenoma detection rate (ADR) [ Time Frame: during procedure ]
    rate (%) of colonoscopies with one or more adenoma detected


Secondary Outcome Measures :
  1. Polyp detection rate (PDR) [ Time Frame: during procedure ]
    rate (%) of colonoscopies with one or more polyp detected

  2. Advanced neoplasia detection rate (ANDR) [ Time Frame: during procedure ]
    rate (%) of colonoscopies with one or more advanced neoplasia detected

  3. Serrated polyp detection rate (SPDR) [ Time Frame: during procedure ]
    rate (%) of colonoscopies with one or more serrated polyp detected

  4. Morbidity: perforation rate (%) [ Time Frame: 21 days after procedure ]
    Perforation rates (%)

  5. Morbidity: bleeding rate (%) [ Time Frame: 21 days after procedure ]
    Bleeding rates (%)

  6. caecal intubation rate (%) [ Time Frame: during procedure ]
    caecal intubation rate (complete colonoscopy)

  7. Time to reach caecum (sec) [ Time Frame: during procedure ]
    Time to reach caecum from the beginning of the procedure (in seconds)

  8. withdrawal time (sec) [ Time Frame: during procedure ]
    withdrawal time of the scope from the caecum to the end of the procedure (in seconds)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient scheduled for total colonoscopic exploration, during the period study
  2. Patient over or equal to 18 years
  3. ASA 1, ASA 2, ASA 3
  4. No participation in another clinical study
  5. Certificate of non opposition signed

Exclusion Criteria:

  1. Patient under 18 years old
  2. ASA 4, ASA 5
  3. Pregnant woman
  4. Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
  5. Inflammatory bowel disease
  6. Known colonic stenosis
  7. Diverticulitis less than 6 weeks old
  8. Patient unable to give consent or protected by law
  9. Opposition expressed for inclusion in the study

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): NCT03344055


Contacts
Contact: David Karsenti, MD +33 143967850 karsenti@club-internet.fr

Locations
France
Clinique PARIS-BERCY Recruiting
Charenton-le-Pont, France, 94220
Contact: David Karsenti       karsenti@club-internet.fr   
Sponsors and Collaborators
Société Française d'Endoscopie Digestive

Responsible Party: KARSENTI, MD, Principal Investigator, Société Française d'Endoscopie Digestive
ClinicalTrials.gov Identifier: NCT03344055     History of Changes
Other Study ID Numbers: 2017-A00549-44
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by KARSENTI, Société Française d'Endoscopie Digestive:
Adenoma Detection Rate
Endocuff
Colonoscopy

Additional relevant MeSH terms:
Adenoma
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical