CUFF-assisted Colonoscopy vs Standard Colonoscopy

NCT ID: NCT03758872

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1034 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-25
• Study Completion Date: 2019-09-26

Brief Summary

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 in routine colonoscopy.

This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group

Conditions

Colonic Polyp; Colonoscopy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

historical comparaison whithout cuff

517 patients included in 2017 without CUFF and 517 patients will be included in 2018 with CUFF for polyp detection

cuff assisted colonoscopy(with cuff use of endocuff vision second generation)

Intervention Type: DIAGNOSTIC_TEST

this is a cohort prospective comparative, a group without cuff in 2017, 517 patient included in the retrospective phase, and in 2018, 517 patient will be included in the prospective phase with CUFF for detecting polyps

Interventions

cuff assisted colonoscopy(with cuff use of endocuff vision second generation)

this is a cohort prospective comparative, a group without cuff in 2017, 517 patient included in the retrospective phase, and in 2018, 517 patient will be included in the prospective phase with CUFF for detecting polyps

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

colonoscopy with polypectomy or mucosectomy; standard colonoscopy ( without use of endocuff vision)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique du Trocadéro

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Du Trocadero

Paris, , France

Countries

France

Other Identifiers

2018-A01397-48

Identifier Type: -

Identifier Source: org_study_id