Computer Aided Detection, Tandem Colonoscopy Study

Study Overview
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Brief Summary
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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.

Official Title
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Computer Aided Detection, Tandem Colonoscopy Study

Conditions
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Colonic Diseases

Intervention / Treatment
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* Diagnostic Test: Standard technique First
* Diagnostic Test: combination technique First


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Technique followed by Combination<br>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). | Diagnostic Test: Standard technique First<br>* colonoscopy without automated polyp detection software<br>|
| Active Comparator: Combination +followed by Standard Technique<br>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) | Diagnostic Test: combination technique First<br>* automated polyp detection software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR) | 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. | 1 Year |