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CUFF-assisted Colonoscopy vs Standard Colonoscopy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03758872
Acronym
CUFF-TROCADERO
Enrollment
1034
Registered
2018-11-29
Start date
2018-10-25
Completion date
2019-09-26
Last updated
2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyp, Colonoscopy

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

Interventions

DIAGNOSTIC_TESTcuff 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

Sponsors

Clinique du Trocadéro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
detection of polyp or adenoma with cuffduring procedure

Secondary

MeasureTime frameDescription
POLYP DETECTION RATEduring procedure
morbidity : perforation rate21 DAYS AFTER PROCEDURE
CAECAL INTUBATION RATEDURING PROCEDURE
TIME TO REACH CAECUMDURING PROCEDURESEC
WITHDRAWAL TIMEDURING PROCEDURESEC

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026