Computer Aided Detection, Tandem Colonoscopy Study

June 28, 2021 updated by: NYU Langone Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Technique followed by Combination
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
colonoscopy without automated polyp detection software
ACTIVE_COMPARATOR: Combination +followed by Standard Technique
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
automated polyp detection software

What is the study measuring?

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)
Time Frame: 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.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Seth Gross, MD, New York Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 17, 2020

Primary Completion (ACTUAL)

October 14, 2020

Study Completion (ACTUAL)

October 14, 2020

Study Registration Dates

First Submitted

August 29, 2019

First Submitted That Met QC Criteria

August 29, 2019

First Posted (ACTUAL)

August 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-00801

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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