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Clinical Trials/NCT03758872
NCT03758872CompletedNot Applicable

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

Clinique du Trocadéro1 site in 1 country1,034 target enrollmentStarted: October 25, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,034
Locations
1
Primary Endpoint
detection of polyp or adenoma with cuff
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

detection of polyp or adenoma with cuff

Time Frame: during procedure

Secondary Outcomes

  • POLYP DETECTION RATE(during procedure)
  • morbidity : perforation rate(21 DAYS AFTER PROCEDURE)
  • CAECAL INTUBATION RATE(DURING PROCEDURE)
  • TIME TO REACH CAECUM(DURING PROCEDURE)
  • WITHDRAWAL TIME(DURING PROCEDURE)

Investigators

Sponsor
Clinique du Trocadéro
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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