Computer Aided Detection, Tandem Colonoscopy Study

Not Applicable

Completed

• Conditions: Colonic Diseases
• Interventions: Diagnostic Test: Standard technique First; Diagnostic Test: combination technique First

• Registration Number: NCT04074577
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this project is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine in real-time how a computer-aided detection (CADe) algorithm will perform when compared to standard screening or surveillance colonoscopy alone. Design will be a multi-center, prospective, unblinded randomized tandem colonoscopy study. 196 patients referred for either screening or surveillance colonoscopy will be included.

Detailed Description

Not available

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: 2019-08-29
• Study First Submitted QC: 2019-08-29
• Study First Posted: 2019-08-30
• Study Start: 2020-09-17
• Primary Completion: 2020-10-14
• Study Completion: 2020-10-14
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients presenting to the endoscopy unit for a screening colonoscopy or a surveillance colonoscopy
• Willingness to undergo tandem colonscopies with and without the use of computer-aided software while undergoing conventional colonoscopy with sedation
• Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation

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Exclusion Criteria

• People with diminished cognitive capacity
• Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active GI bleed)
• Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation)
• Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation).
• Patients with inflammatory bowel disease
• Patients referred for endoscopic mucosal resection (EMR)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Technique followed by Combination	Standard technique First	Back-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. The first colonoscopy will be performed without automated polyp detection software (standard technique) followed immediately by another colonoscopy with automated polyp detection software (combination technique).
Combination +followed by Standard Technique	combination technique First	Back-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. In this arm, the first colonoscopy with be performed with automated polyp detection software (combination technique) followed immediately by another colonoscopy without automated polyp detection software (standard technique)

Primary Outcome Measures

Name	Time	Method
Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR)	1 Year	AMR will be calculated as the number of adenomas detected on the second pass or portion in either group divided by the total number of adenomas detected during both passes.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States