A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 592
- Locations
- 2
- Primary Endpoint
- Adenoma Detection Rates
Study Overview
Brief Summary
The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.
Detailed Description
This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Screening or Surveillance Colonoscopy
- •Able to provide written informed consent
Exclusion Criteria
- •Known narrow colon or colon stenosis
- •Personal history of Colorectal cancer
- •History of inflammatory bowel disease
- •Familial adenomatous polyposis syndrome (FAP)
- •Hyperplastic polyposis syndrome
- •Referral for incomplete colonoscopy or polyp clearance
Arms & Interventions
Control Arm (Standard Colonoscopy)
Standard colonoscopy with no device attachment.
EndoRings Colonoscopy
Colonoscopy with EndoRings device attached to the distal end of the scope.
Intervention: EndoRings device (Device)
Outcomes
Primary Outcomes
Adenoma Detection Rates
Time Frame: During colonoscopy procedure
Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.
Number of Adenomas Per Colonoscopy
Time Frame: During colonoscopy procedure
Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.
Secondary Outcomes
- Polyp Detection Rate(During colonoscopy procedure)
- Problems Encountered With Equipment(During colonoscopy procedure)
- Total Number of Detections(During colonoscopy procedure)
- Cecal Intubation Rate(During colonoscopy procedure)
- Time Comparison for Each Method(During colonoscopy procedure)
- Number of Detections Per Colonoscopy(During colonoscopy procedure)
- Patient Comfort Score(After colonoscopy was completed while patient was in recovery area of endoscopy unit)
Investigators
Douglas K. Rex
Professor of Medicine
Indiana University