A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
A 4-arm Randomized Controlled Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
1 other identifier
interventional
1,262
1 country
1
Brief Summary
Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
March 12, 2019
CompletedMarch 12, 2019
February 1, 2019
2.8 years
January 13, 2015
December 31, 2018
February 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Adenomas Per Colonoscopy
During Procedure
Secondary Outcomes (14)
Number of Participants With Detected Adenoma
During Procedure
Percentage of Participants With Detected Adenoma
During Procedure
Sessile Serrated Polyps Per Colonoscopy
During Procedure
Number of Participants With Detected Sessile Serrated Polyp
During Procedure
Percentage of Participants With Detected Sessile Serrated Polyp
During Procedure
- +9 more secondary outcomes
Study Arms (4)
FUSE® Colonoscopy
ACTIVE COMPARATORA FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
Colonoscopy with EndoCuff™
ACTIVE COMPARATORAn EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™
ACTIVE COMPARATORAn EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Standard Colonoscopy
ACTIVE COMPARATORA standard colonoscope will be used to complete the procedure
Interventions
colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
colonoscopy performed with the FUSE® (full spectrum endoscopy) system
colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
Eligibility Criteria
You may qualify if:
- Screening or Surveillance Colonoscopy
You may not qualify if:
- Personal history of Colorectal cancer or Inflammatory bowel disease
- Surgical resection of the colon or known colonic stricture
- Personal or family history of Polyposis syndromes or Lynch syndrome
- Referral for incomplete colonoscopy or known therapeutic polyp clearance
- Severe diverticular disease
- Referral for a positive hemoccult test in the past 6 months
- Known coagulopathy
- Inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Related Publications (1)
Rex DK, Repici A, Gross SA, Hassan C, Ponugoti PL, Garcia JR, Broadley HM, Thygesen JC, Sullivan AW, Tippins WW, Main SA, Eckert GJ, Vemulapalli KC. High-definition colonoscopy versus Endocuff versus EndoRings versus full-spectrum endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial. Gastrointest Endosc. 2018 Aug;88(2):335-344.e2. doi: 10.1016/j.gie.2018.02.043. Epub 2018 Mar 9.
PMID: 29530353DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
* Recruitment was uneven across the sites, and there were some differences between sites with regard to detection. Thus, some caution is appropriate in concluding generalizability. * Endoscopists were not blinded to which device was in use.
Results Point of Contact
- Title
- Rachel Lahr
- Organization
- Indiana University
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas Rex, MD
Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 13, 2015
First Posted
January 26, 2015
Study Start
February 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
March 12, 2019
Results First Posted
March 12, 2019
Record last verified: 2019-02