EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection
A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas
1 other identifier
interventional
500
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
4 active sites
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
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 6, 2014
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMarch 7, 2018
March 1, 2018
6 months
January 6, 2014
March 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adenoma detection rate
completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.
25 minutes
Secondary Outcomes (8)
polyp detection rate
1 Week
number of LGIN and HGIN adenomas detected
one week
polyp distribution
25 minutes
procedure time
25 Minutes
withdrawal time
10 Minutes
- +3 more secondary outcomes
Study Arms (2)
Endocuff-assisted colonoscopy
ACTIVE COMPARATOREndocuff-assisted colonoscopy
Standard colonoscopy
ACTIVE COMPARATORStandard Colonoscopy
Interventions
Eligibility Criteria
You may qualify if:
- indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent
You may not qualify if:
- pregnancy
- age\<18 years
- known colonic strictures
- chronic inflammatory bowel disease
- active inflammation
- s/p colonic resection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University Medical Center Göttingen
Göttingen, 37575, Germany
HELIOS St. Marienberg Hospital Helmstedt
Helmstedt, 38350, Germany
Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
Northeim, 37154, Germany
HELIOS Medical Center Siegburg, Department of Gastroenterology
Siegburg, 53721, Germany
Related Publications (1)
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.
PMID: 25470133DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tobias Meister, M.D.
Helios Albert-Schweitzer-Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med.
Study Record Dates
First Submitted
January 6, 2014
First Posted
January 14, 2014
Study Start
January 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
March 7, 2018
Record last verified: 2018-03