Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

Not Applicable

Completed

• Conditions: Colorectal Adenoma; Colorectal Polyp; Colon Cancer
• Interventions: Device: Endocuff Vision

• Registration Number: NCT03361917
• Lead Sponsor: Indiana University

Brief Summary

This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

Detailed Description

For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

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: 2017-11-29
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-05
• Study Start: 2017-12-11
• Primary Completion: 2018-04-18
• Study Completion: 2018-04-18
• Results First Submitted: 2019-04-05
• Results First Submitted QC: 2019-05-03
• Results First Posted: 2019-05-22
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subject referred for a screening or surveillance colonoscopy
• Subject is aged 40 years or older
• Subject has the ability to provide informed consent

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Exclusion Criteria

• Prior history of colon cancer
• History of inflammatory bowel disease
• Prior surgical resection of any part of the colon
• Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure
• History of polyposis syndrome or HNPCC
• Family history of colon cancer in a first-degree relative < 60 years or two first degree relatives with colorectal cancer
• Inability to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endocuff Vision	Endocuff Vision	Colonoscopy with Endocuff Vision attached to distal end of scope

Primary Outcome Measures

Name	Time	Method
Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)	During the withdrawal portion of the colonoscopy procedure	Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.

Secondary Outcome Measures

Name	Time	Method
Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)	During the insertion portion of the colonoscopy procedure	Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.
Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)	During the colonoscopy procedure	Total procedure time is the time from the initial insertion through the complete withdrawal of the scope
Polyps Per Colonoscopy	During the colonoscopy procedure	Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.
Detection Rates	During the colonoscopy procedure	The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.
Boston Bowel Preparation Score	During the withdrawal portion of the colonoscopy procedure after cleaning of the colon	Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision.; The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality.; The quality of the bowel preparation is assessed by the attending gastroenterologist.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States