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OpenTrials
Completed

NCT Number: NCT04979962

AI Colorectal Polyp Detection

This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.

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Key information

Conditions

Polyp Colorectal Adenoma Colon

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck Medicine University of Southern California, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)
  • Patients aged 45 or older
  • Patients who can provide an informed consent

Exclusion criteria

  • Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease
  • Patients who are pregnant or are planning pregnancy during study period
  • Patients who are not able to or refuse to give informed consent

Treatment and study plan

EW10-EC02 (Endoscopy Support Program)

Device

EW10-EC02 is intended to automatically detect the location of suspected polyps in colonoscopy exams. Identified polyps are highlighted to the clinician in real-time during the exam, as a video image superimposed on the endoscope monitor. EW10-EC02 is limited to the detection of suspected findings, and should not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis.

Primary outcomes

  1. Adenoma per colonoscopy (APC)

    Time frame: 1 day/procedure

    Total number of histologically confirmed adenomas and carcinomas detected in the colonoscopy divided by the total number of colonoscopies

Secondary outcomes

  1. Positive predictive value (PPV)

    Time frame: 1 day/procedure

    Total number of histologically confirmed adenomas and carcinomas detected during the colonoscopy, divided by the total number of excisions in the colonoscopy

  2. Adenoma detection rate (ADR)

    Time frame: 1 day/procedure

    proportion of patients with at least one histologically confirmed adenoma or carcinoma detected in the colonoscopy

Sponsors and collaborators

Lead sponsor

Fujifilm Medical Systems USA, Inc.

Industry

Registry information

Official study title

Colorectal Polyp Detection Comparing Computer Assisted Colonoscopy With Conventional Colonoscopy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2021
Registry last updated
Sep 18, 2023

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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