Computer Aided Detection, Tandem Colonoscopy Study

NCT04074577 | Completed

• 1 other identifier: 19-00801
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard Technique followed by Combination

ACTIVE COMPARATOR

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

Combination +followed by Standard Technique

ACTIVE COMPARATOR

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

Interventions

Standard technique First DIAGNOSTIC_TEST

colonoscopy without automated polyp detection software

Standard Technique followed by Combination

combination technique First DIAGNOSTIC_TEST

automated polyp detection software

Combination +followed by Standard Technique

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Seth Gross, MD

  New York Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: August 30, 2019
• Study Start: September 17, 2020
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

US (1)