Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

Not Applicable

Completed

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

• Registration Number: NCT03560128
• Lead Sponsor: Indiana University

Brief Summary

The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.

Detailed Description

This will be a prospective, randomized controlled study. Subjects referred for a screening, surveillance, or diagnostic colonoscopy will be prospectively enrolled. This study aims to compare the number of adenomas detected per colonoscopy (APC) between an Endocuff colonoscopy and an AmplifEYE colonoscopy.

It is estimated that the Endocuff Vision will result in an APC of 2.3. The investigators consider that a clinically acceptable ADR for the Medivators device would be within 20% of this value or 1.5.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-04-12
• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-18
• Primary Completion: 2018-12-18
• Study Completion: 2018-12-18
• Status Verified: 2019-09
• Results First Submitted: 2019-09-20
• Results First Submitted QC: 2019-09-20
• Last Update Submitted: 2019-09-20
• Results First Posted: 2019-10-08
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 634

Inclusion Criteria

• 40 years of age or older
• Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
• Able to provide written informed consent

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Exclusion Criteria

• Active Inflammatory Bowel Disease
• Prior resection of the colon
• Referred for resection of a polyp identified by another physician
• Referred for a previous incomplete colonoscopy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AmplifEYE Arm	AmplifEYE device	Colonoscopy with AmplifEYE device attached to the distal end of the scope.
Endocuff Vision Arm	Endocuff Vision device	Colonoscopy with Endocuff Vision device attached to the distal end of the scope.

Primary Outcome Measures

Name	Time	Method
Number of Adenomas Detected Per Colonoscopy (APC).	During colonoscopy procedure	Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.

Secondary Outcome Measures

Name	Time	Method
Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))	During colonoscopy procedure	Comparison of the number of participants with at least one adenoma detected (ADR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.; Comparison of the number of participants with at least one polyp detected (PDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Complications Encountered During Procedure	During Colonoscopy procedure	Comparison of amount of mucosal trauma (such as scratches), perforation (making a hole in the colon wall), or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.
Passage of Device Through Sigmoid Colon	during insertion portion of colonoscopy	Comparison of the number of times the device had to be removed to pass the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.
Polyps Per Colonoscopy (PPC)	During colonoscopy procedure	Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
Time Comparison for Each Method	During colonoscopy procedure	Comparison of the insertion time, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.; Insertion time: time it takes from the colonoscope first being inserted to when the cecum is reached Withdrawal time: time calculated from when withdrawing is started in the cecum until the colonoscope is removed. This includes time spent washing, suctioning, inspecting the colon, and removing polyps.; Inspection time: time spent actually examining the colon and does not include time spent for washing the colon, suctioning, and removing polyps.; Total procedure time: time from the initial insertion of the colonoscope through the complete withdrawal of the colonoscope.
Cecal Intubation Rate	During Colonoscopy procedure	Comparison of the number of procedures where the colonoscope was able to reach the cecum between AmplifEYE colonoscopy and Endocuff Vision colonoscopy.
Detection of Serrated Lesions	During colonoscopy procedure	Comparison of the number of participants with at least one Sessile Serrated Polyp detected (SSPDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.; Comparison of the number of participants with at least one flat polyp detected between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States