NCT03344055

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,059

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

November 12, 2017

Last Update Submit

January 26, 2019

Conditions

Colonic AdenomaColonic PolypColonoscopy

Keywords

Adenoma Detection RateEndocuffColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate (ADR)

    rate (%) of colonoscopies with one or more adenoma detected

    during procedure

Secondary Outcomes (8)

  • Polyp detection rate (PDR)

    during procedure

  • Advanced neoplasia detection rate (ANDR)

    during procedure

  • Serrated polyp detection rate (SPDR)

    during procedure

  • Morbidity: perforation rate (%)

    21 days after procedure

  • Morbidity: bleeding rate (%)

    21 days after procedure

  • +3 more secondary outcomes

Study Arms (2)

Colonoscopy with Endocuff Vision (ECV)

ACTIVE COMPARATOR

ECV-assisted colonoscopy ( with the use of Endocuff Vision (ECV) Second generation)

Device: Endocuff Vision (ECV) second generation

Standard colonoscopy

NO INTERVENTION

Standard colonoscopy (without the use of Endocuff Vision (ECV) Second generation)

Interventions

Endocuff Vision (ECV) second generationDEVICE

Colonoscopy performed with the use of "Endocuff Vision (ECV) second generation" at the tip of the scope

Colonoscopy with Endocuff Vision (ECV)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique PARIS-BERCY

Charenton-le-Pont, 94220, France

Location

Related Publications (1)

  • Karsenti D, Tharsis G, Perrot B, Cattan P, Tordjman G, Venezia F, Zrihen E, Gillot D, Gillet A, Hagege C, Samama J, Etienney I, Lab JP, Guigui B, Zago J, Benkessou B, Burtin P, Cavicchi M. Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial. Gut. 2020 Dec;69(12):2159-2164. doi: 10.1136/gutjnl-2019-319565. Epub 2020 Mar 24.

    PMID: 32209605DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

November 12, 2017

First Posted

November 17, 2017

Study Start

November 15, 2017

Primary Completion

November 15, 2018

Study Completion

November 15, 2018

Last Updated

January 29, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)