EndoRings Colonoscopy vs Standard Colonoscopy

Not Applicable

Completed

• Conditions: Colorectal Polyp; Colon Cancer; Colorectal Adenoma
• Interventions: Device: EndoRings device

• Registration Number: NCT03418662
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-02
• Study Start: 2018-01-19
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-02-01
• Primary Completion: 2018-09-13
• Study Completion: 2018-09-13
• Results First Submitted: 2019-07-30
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Results First Posted: 2019-09-20
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

Inclusion Criteria

• Screening or Surveillance Colonoscopy
• Able to provide written informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EndoRings Colonoscopy	EndoRings device	Colonoscopy with EndoRings device attached to the distal end of the scope.

Primary Outcome Measures

Name	Time	Method
Adenoma Detection Rates	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	During colonoscopy procedure	Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.

Secondary Outcome Measures

Name	Time	Method
Polyp Detection Rate	During colonoscopy procedure	Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.
Problems Encountered With Equipment	During colonoscopy procedure	Occurrences of slippage of EndoRings or of device being removed on insertion.
Total Number of Detections	During colonoscopy procedure	Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.
Cecal Intubation Rate	During colonoscopy procedure	Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy.
Time Comparison for Each Method	During colonoscopy procedure	Comparison of the time required to reach the cecum, withdrawal time, and total procedure time.; Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps.; Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal).
Number of Detections Per Colonoscopy	During colonoscopy procedure	Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.
Patient Comfort Score	After colonoscopy was completed while patient was in recovery area of endoscopy unit	Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome).

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States