EndoRings Colonoscopy for Adenoma Detection
ER
EndoRings Versus Standard Colonoscopy for Adenoma Detection
1 other identifier
interventional
225
1 country
5
Brief Summary
Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy. EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2018
CompletedFirst Posted
Study publicly available on registry
March 19, 2018
CompletedStudy Start
First participant enrolled
March 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 12, 2019
February 1, 2019
1.8 years
March 6, 2018
February 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma detection rate
during colonoscopy
Study Arms (2)
EndoRings
ACTIVE COMPARATORColonoscopy is performed with the EndoRings attached
Standard Colonoscopy
ACTIVE COMPARATORStandard colonoscopy without any additional devices
Interventions
Eligibility Criteria
You may qualify if:
- indication for colonoscopy (screening, surveillance, diagnostic)
- age ≥ 45 years
- ability to give informed consent
You may not qualify if:
- pregnancy
- age \<45 years
- known colonic strictures
- chronic inflammatory bowel disease
- active inflammation
- s/p colonic resection
- bleeding disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
HELIOS HSK Kliniken
Wiesbaden, Hesse, 65199, Germany
Department of Gastroenterology, University Medical Center
Göttingen, Lower Saxony, 37075, Germany
HELIOS St. Marienberg Klinik Helmstedt
Helmstedt, Germany
Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
Northeim, 37154, Germany
HELIOS Medical Center Siegburg
Siegburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tobias Meister, Prof. Dr.
HELIOS Albert-Schweitzer Klinik
- PRINCIPAL INVESTIGATOR
Ralf Kiesslich, Prof. Dr.
HELIOS HSK Kliniken Wiesbaden
Central Study Contacts
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
- SPONSOR
Study Record Dates
First Submitted
March 6, 2018
First Posted
March 19, 2018
Study Start
March 27, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
February 12, 2019
Record last verified: 2019-02