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Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate? (Endorings-2)

Primary Purpose

Colonic Adenoma, Colonic Polyp, Colonic Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Endorings-2
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Adenoma focused on measuring Colonoscopy; adenoma detection rate; endorings-2; endorings; device-assisted colonoscopy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with an indication for a screening colonoscopy.

Exclusion Criteria:

  • Patients under 18 years, pregnancy
  • Patients with prior colectomy or partial colectomy
  • Patients with a history of colorectal cancer
  • Patients with hereditary polyposis syndromes (FAP, HNPCC)
  • Patients with a stricture of the colon
  • Patients receiving anticoagulation prohibiting a colonoscopy
  • inability to have a patient education
  • bad conditions prohibiting a colonoscopy

Sites / Locations

  • Unversity Clinic MuensterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Endorings-assisted screening colonoscopy

Standard screening colonoscopy

Arm Description

146 patients with an indication for screening endoscopy will receive an Endorings-2-assisted colonoscopy.

146 patients with an indication for screening endoscopy will receive a standard colonoscopy.

Outcomes

Primary Outcome Measures

Evaluation of the adenoma detection rate during screening colonoscopy
The primary outcome of this study is the adenoma detection rate of the standard colonoscopy in comparison to the Endorings-assisted colonoscopy.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2017
Last Updated
June 15, 2020
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT03385434
Brief Title
Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?
Acronym
Endorings-2
Official Title
Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas, precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas are missed during the examination. Recently a new colonoscopy accessory, the Endorings-2 (EndoAid Ltd., Casearea, Israel), has been designed to improved the detection of adenomas during colonoscopy (adenoma detection rate). Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped with circular flexible silicon rings mechanically stretching the colonic folds during withdrawal. This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate in a prospective, blinded clinical trial. 292 patients with an indication for a screening colonoscopy shall be included (1:1 randomization in standard colonoscopy versus Endorings-2-assisted colonoscopy).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Adenoma, Colonic Polyp, Colonic Neoplasms, Colonoscopy
Keywords
Colonoscopy; adenoma detection rate; endorings-2; endorings; device-assisted colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
292 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endorings-assisted screening colonoscopy
Arm Type
Experimental
Arm Description
146 patients with an indication for screening endoscopy will receive an Endorings-2-assisted colonoscopy.
Arm Title
Standard screening colonoscopy
Arm Type
No Intervention
Arm Description
146 patients with an indication for screening endoscopy will receive a standard colonoscopy.
Intervention Type
Device
Intervention Name(s)
Endorings-2
Other Intervention Name(s)
Endorings-2 (EndoAid Ltd, Caesarea, Israel)
Intervention Description
292 patients with an indication for screening colonoscopy will be included. 146 patients will receive a standard colonoscopy and 146 patients will receive an Endorings-2 assisted colonoscopy (1:1 standard colonoscopy vs Endorings-2-assisted colonoscopy).
Primary Outcome Measure Information:
Title
Evaluation of the adenoma detection rate during screening colonoscopy
Description
The primary outcome of this study is the adenoma detection rate of the standard colonoscopy in comparison to the Endorings-assisted colonoscopy.
Time Frame
Intraoperative. Adenomas detected directly during the examination.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with an indication for a screening colonoscopy. Exclusion Criteria: Patients under 18 years, pregnancy Patients with prior colectomy or partial colectomy Patients with a history of colorectal cancer Patients with hereditary polyposis syndromes (FAP, HNPCC) Patients with a stricture of the colon Patients receiving anticoagulation prohibiting a colonoscopy inability to have a patient education bad conditions prohibiting a colonoscopy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Lenze, MD
Phone
+492518357935
Email
frank.lenze@uni-muenster.de
First Name & Middle Initial & Last Name or Official Title & Degree
Arne Bokemeyer, MD
Phone
+492518357935
Email
arne.bokemeyer@ukmuenster.de
Facility Information:
Facility Name
Unversity Clinic Muenster
City
Muenster
State/Province
NRW
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Lenze, MD, PhD
Phone
00492518358103
Email
frank.lenze@uni-muenster.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?

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