Back to results

EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

Primary Purpose

Polyp, Adenoma, Cancer

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

EndoCuff-assisted colonoscopy

Standard colonoscopy

About this trial

This is an interventional diagnostic trial for Polyp focused on measuring colon cancer, adenoma, colon polyps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent

Exclusion Criteria:

pregnancy
age<18 years
known colonic strictures
chronic inflammatory bowel disease
active inflammation
s/p colonic resection

Sites / Locations

University Medical Center Göttingen
HELIOS St. Marienberg Hospital Helmstedt
Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
HELIOS Medical Center Siegburg, Department of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Endocuff-assisted colonoscopy

Standard colonoscopy

Arm Description

Endocuff-assisted colonoscopy

Standard Colonoscopy

Outcomes

Primary Outcome Measures

adenoma detection rate

completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.

Secondary Outcome Measures

polyp detection rate

number of LGIN and HGIN adenomas detected

LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia

polyp distribution

procedure time

withdrawal time

without intervention time due to polypectomy

ileum intubation rate

total colonoscopy rate

adverse events

perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy

Full Information

NCT ID

NCT02034929

First Posted

January 6, 2014

Last Updated

March 6, 2018

Sponsor

Helios Albert-Schweitzer-Klinik Northeim

1. Study Identification

Unique Protocol Identification Number

NCT02034929

Brief Title

EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

Official Title

A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helios Albert-Schweitzer-Klinik Northeim

4. Oversight

5. Study Description

Brief Summary

The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal. The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy. The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polyp, Adenoma, Cancer

Keywords

colon cancer, adenoma, colon polyps

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endocuff-assisted colonoscopy

Arm Type

Active Comparator

Arm Description

Endocuff-assisted colonoscopy

Arm Title

Standard colonoscopy

Arm Type

Active Comparator

Arm Description

Standard Colonoscopy

Intervention Type

Device

Intervention Name(s)

EndoCuff-assisted colonoscopy

Intervention Description

EC-assisted colonoscopy

Intervention Type

Device

Intervention Name(s)

Standard colonoscopy

Intervention Description

Standard colonoscopy

Primary Outcome Measure Information:

Title

adenoma detection rate

Description

completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.

Time Frame

25 minutes

Secondary Outcome Measure Information:

Title

polyp detection rate

Time Frame

1 Week

Title

number of LGIN and HGIN adenomas detected

Description

LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia

Time Frame

one week

Title

polyp distribution

Time Frame

25 minutes

Title

procedure time

Time Frame

25 Minutes

Title

withdrawal time

Description

without intervention time due to polypectomy

Time Frame

10 Minutes

Title

ileum intubation rate

Time Frame

10 minutes

Title

total colonoscopy rate

Time Frame

25 minutes

Title

adverse events

Description

perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy

Time Frame

25 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent Exclusion Criteria: pregnancy age<18 years known colonic strictures chronic inflammatory bowel disease active inflammation s/p colonic resection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tobias Meister, M.D.

Organizational Affiliation

Helios Albert-Schweitzer-Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center Göttingen

City

Göttingen

ZIP/Postal Code

37575

Country

Germany

Facility Name

HELIOS St. Marienberg Hospital Helmstedt

City

Helmstedt

ZIP/Postal Code

38350

Country

Germany

Facility Name

Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital

City

Northeim

ZIP/Postal Code

37154

Country

Germany

Facility Name

HELIOS Medical Center Siegburg, Department of Gastroenterology

City

Siegburg

ZIP/Postal Code

53721

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25470133

Citation

Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.

Results Reference

derived

Learn more about this trial

EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

We'll reach out to this number within 24 hrs