Real-Time CAD for Colonic Neoplasia: A RCT
CAD
Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial
1 other identifier
interventional
1,100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Sep 2022
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2023
CompletedFirst Submitted
Initial submission to the registry
July 19, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedJuly 27, 2023
July 1, 2023
7 months
July 19, 2023
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma Detection Rate
1 year
Secondary Outcomes (5)
Adenomas Per Colon
1 year
Sessile Serrated Lesion Detection Rate
1 year
Sessile Serrated Lesions Per Colon
1 year
False Neoplasia Rate
1 year
Withdrawal Time
1 year
Study Arms (2)
Real-Time Computer Aided Detection
EXPERIMENTALStandard Colonoscopy
ACTIVE COMPARATORInterventions
This intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic)
Eligibility Criteria
You may qualify if:
- Undergoing colonoscopy at RUHS
- Age \> 45 years
- No contraindications to colonoscopy
You may not qualify if:
- Prior history of subtotal colectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riverside University Health System
Moreno Valley, California, 92555, United States
Related Publications (2)
Thiruvengadam NR, Cote GA, Gupta S, Rodrigues M, Schneider Y, Arain MA, Solaimani P, Serrao S, Kochman ML, Saumoy M. An Evaluation of Critical Factors for the Cost-Effectiveness of Real-Time Computer-Aided Detection: Sensitivity and Threshold Analyses Using a Microsimulation Model. Gastroenterology. 2023 May;164(6):906-920. doi: 10.1053/j.gastro.2023.01.027. Epub 2023 Feb 2.
PMID: 36736437BACKGROUNDThiruvengadam NR, Solaimani P, Shrestha M, Buller S, Carson R, Reyes-Garcia B, Gnass RD, Wang B, Albasha N, Leonor P, Saumoy M, Coimbra R, Tabuenca A, Srikureja W, Serrao S. The Efficacy of Real-time Computer-aided Detection of Colonic Neoplasia in Community Practice: A Pragmatic Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2024 Nov;22(11):2221-2230.e15. doi: 10.1016/j.cgh.2024.02.021. Epub 2024 Mar 2.
PMID: 38437999DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2023
First Posted
July 27, 2023
Study Start
September 1, 2022
Primary Completion
March 31, 2023
Study Completion
May 27, 2023
Last Updated
July 27, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share