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NCT03758872 Clinical Trial

CUFF-assisted Colonoscopy vs Standard Colonoscopy

Colonoscopy Clinical Trial

— CUFF-TROCADERO  

Official title:
USE OF ENDOCUFF SECOND GENERATION IN THE COLIC POLYPS DETECTION: HISTORIC COHORTE PROSPECTIVE COMPARATIVE

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03758872
Other study ID # 2018-A01397-48
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 25, 2018
Est. completion date September 26, 2019

Study information
Verified date October 2018
Source Clinique du Trocadéro
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 1034
Est. completion date September 26, 2019
Est. primary completion date September 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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

Locations
Country Name City State
France Clinique Du Trocadero Paris

Sponsors (1)
Lead Sponsor Collaborator
Clinique du Trocadéro

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary detection of polyp or adenoma with cuff during procedure
Secondary POLYP DETECTION RATE during procedure
Secondary morbidity : perforation rate 21 DAYS AFTER PROCEDURE
Secondary CAECAL INTUBATION RATE DURING PROCEDURE
Secondary TIME TO REACH CAECUM SEC DURING PROCEDURE
Secondary WITHDRAWAL TIME SEC DURING PROCEDURE
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