Computer Aided Detection, Tandem Colonoscopy Study

NYU Langone Health

Status: Completed

Conditions: Colonic Diseases

Treatments: Diagnostic Test: combination technique First; Diagnostic Test: Standard technique First

Study type: Interventional

Funder types: Other

Identifiers

NCT04074577

19-00801

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Standard Technique followed by Combination

Active Comparator group

Description:

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).

Treatment:

Diagnostic Test: Standard technique First

Combination +followed by Standard Technique

Active Comparator group

Description:

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)

Treatment:

Diagnostic Test: combination technique First