AI Colorectal Polyp Detection

September 15, 2023 updated by: Fujifilm Medical Systems USA, Inc.

Colorectal Polyp Detection Comparing Computer Assisted Colonoscopy With Conventional Colonoscopy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1162

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
    • California
      • Los Angeles, California, United States, 90033
        • Keck Medicine University of Southern California
    • Florida
      • Largo, Florida, United States, 33770
        • Largo Medical Center (HCA)
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Brigham and Women's Hospital
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • GI Associates
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10016
        • New York University/Manhattan Endoscopy
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAC Group
Inspection with computer assisted colonoscopy.
Device: EW10-EC02 (Endoscopy Support Program)
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.
No Intervention: CC Group
Inspection with conventional colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day/procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day/procedure
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
1 day/procedure

Collaborators and Investigators

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

Sponsor

Fujifilm Medical Systems USA, Inc.

Investigators

  • Principal Investigator: Prateek Sharma, MD, Kansas City VA Medical Center

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)

November 24, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

November 21, 2022

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-21-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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