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OpenTrials
Completed

NCT Number: NCT04074577

Computer Aided Detection, Tandem Colonoscopy Study

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.

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Key information

Conditions

Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard technique First

Diagnostic Test

colonoscopy without automated polyp detection software

combination technique First

Diagnostic Test

automated polyp detection software

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2019
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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