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OpenTrials
Completed

NCT Number: NCT03637712

Deep-Learning for Automatic Polyp Detection During Colonoscopy

The primary objective of this study is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine whether a combination of colonoscopy and an automatic polyp detection software is a feasible way to increase adenoma detection rate compared to standard colonoscopy.

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Key information

Age range

18 year–99 year

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: No

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

Inclusion criteria

  • Patients presenting for routine colonoscopy for screening and/or surveillance purposes.
  • Ability to provide written, informed consent and understand the responsibilities of trial participation

Exclusion criteria

  • People with diminished cognitive capacity.
  • The subject is pregnant or planning a pregnancy during the study period.
  • 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 with any polypoid/ulcerated lesion > 20mm concerning for invasive cancer on endoscopy.

Treatment and study plan

Computer Algorithm

Device

This device is a computer algorithm that runs in the background during routine screening or surveillance colonoscopy that is designed to aid in the detection of polyps

Primary outcomes

  1. Adenoma Detection Rate

    Time frame: 1 Day

    the proportion of colonoscopic examinations performed that detect one or more polyp

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 20, 2018
Registry last updated
May 15, 2020

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.

Published trials that share one or more normalized conditions with this study.