Real-Time CAD for Colonic Neoplasia: A RCT (CAD)

July 19, 2023 updated by: Riverside University Health System Medical Center

Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial

This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. This study will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.

Study Type

Interventional

Enrollment (Actual)

1100

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
      • Moreno Valley, California, United States, 92555
        • Riverside University Health System

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing colonoscopy at RUHS
  • Age > 45 years
  • No contraindications to colonoscopy

Exclusion Criteria:

  • Prior history of subtotal colectomy

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real-Time Computer Aided Detection
Device: Real-Time Computer Aided Detection
This intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic)
Active Comparator: Standard Colonoscopy
Procedure: Stanford Colonoscopy
This involves white-light colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adenoma Detection Rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Adenomas Per Colon
Time Frame: 1 year
1 year
Sessile Serrated Lesion Detection Rate
Time Frame: 1 year
1 year
Sessile Serrated Lesions Per Colon
Time Frame: 1 year
1 year
False Neoplasia Rate
Time Frame: 1 year
1 year
Withdrawal Time
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Riverside University Health System Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

May 27, 2023

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1922564-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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