Colonoscopy Clinical Trial
— Cuff-BercyOfficial title:
Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice
Verified date | January 2019 |
Source | Société Française d'Endoscopie Digestive |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 2059 |
Est. completion date | November 15, 2018 |
Est. primary completion date | November 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Clinique PARIS-BERCY | Charenton-le-Pont |
Lead Sponsor | Collaborator |
---|---|
Société Française d'Endoscopie Digestive |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma detection rate (ADR) | rate (%) of colonoscopies with one or more adenoma detected | during procedure | |
Secondary | Polyp detection rate (PDR) | rate (%) of colonoscopies with one or more polyp detected | during procedure | |
Secondary | Advanced neoplasia detection rate (ANDR) | rate (%) of colonoscopies with one or more advanced neoplasia detected | during procedure | |
Secondary | Serrated polyp detection rate (SPDR) | rate (%) of colonoscopies with one or more serrated polyp detected | during procedure | |
Secondary | Morbidity: perforation rate (%) | Perforation rates (%) | 21 days after procedure | |
Secondary | Morbidity: bleeding rate (%) | Bleeding rates (%) | 21 days after procedure | |
Secondary | caecal intubation rate (%) | caecal intubation rate (complete colonoscopy) | during procedure | |
Secondary | Time to reach caecum (sec) | Time to reach caecum from the beginning of the procedure (in seconds) | during procedure | |
Secondary | withdrawal time (sec) | withdrawal time of the scope from the caecum to the end of the procedure (in seconds) | during procedure |
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