- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05963724
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
-
-
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
|
This intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic)
|
Active Comparator: Standard 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.
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.
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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