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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05963724
Recruitment Status : Completed
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Riverside University Health System Medical Center

Tracking Information
First Submitted Date  ICMJE July 19, 2023
First Posted Date  ICMJE July 27, 2023
Last Update Posted Date July 27, 2023
Actual Study Start Date  ICMJE September 1, 2022
Actual Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2023)		 Adenoma Detection Rate [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2023)
  • Adenomas Per Colon [ Time Frame: 1 year ]
  • Sessile Serrated Lesion Detection Rate [ Time Frame: 1 year ]
  • Sessile Serrated Lesions Per Colon [ Time Frame: 1 year ]
  • False Neoplasia Rate [ Time Frame: 1 year ]
  • Withdrawal Time [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Real-Time CAD for Colonic Neoplasia: A RCT
Official Title  ICMJE Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE
  • Colorectal Cancer
  • Colorectal Neoplasms
Intervention  ICMJE
  • Device: Real-Time Computer Aided Detection
    This intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic)
  • Procedure: Stanford Colonoscopy
    This involves white-light colonoscopy
Study Arms  ICMJE
  • Experimental: Real-Time Computer Aided Detection
    Intervention: Device: Real-Time Computer Aided Detection
  • Active Comparator: Standard Colonoscopy
    Intervention: Procedure: Stanford Colonoscopy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2023)		 1100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 27, 2023
Actual Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior history of subtotal colectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05963724
Other Study ID Numbers  ICMJE 1922564-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Riverside University Health System Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Riverside University Health System Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Riverside University Health System Medical Center
Verification Date July 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP