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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03344055
Other study ID # 2017-A00549-44
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2017
Est. completion date November 15, 2018

Study information

Verified date January 2019
Source Société Française d'Endoscopie Digestive
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Description:

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.

Number of patients:

2000 patients, 1000 in each group (with and without ECV). To limit the risk of bias, the investigators will random two teams of 12 endoscopists matched in number, volume of activity and Adenoma Detection Rate (evaluated over a period of the year preceding the study).

Both periods of study will be approximately 3-4 months in length. In order to achieve a perfect balance between the two groups of patients, an inclusion tracking chart will be initiate and will be carefully controlled. Rebalancing will be done for both periods of study to obtain 500 patients per group and per period (= 2000 patients included).

Inclusion of 500 consecutive colonoscopies in each team of investigators, a "colonoscopy with ECV" team, a "colonoscopy without ECV" team then switch and inclusion of 500 new consecutive colonoscopies in each team, ie 2000 colonoscopies in total.

The selection of the team that will begin with ECV (Team A) and the team that will finish with ECV (Team B) will be chosen at random before the start of the study.

A comparison of the two colonoscopy groups with ECV vs without ECV will be made for each team (the investigator will be his own control) and then on the overall population after the end of the trial.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
France Clinique PARIS-BERCY Charenton-le-Pont

Sponsors (1)

Lead Sponsor Collaborator
Société Française d'Endoscopie Digestive

Country where clinical trial is conducted

France, 

Outcome

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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