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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Neoplasms Device: Real-Time Computer Aided Detection Procedure: Stanford Colonoscopy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial
Actual Study Start Date : September 1, 2022
Actual Primary Completion Date : March 31, 2023
Actual Study Completion Date : May 27, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Adenoma Detection Rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Adenomas Per Colon [ Time Frame: 1 year ]
  2. Sessile Serrated Lesion Detection Rate [ Time Frame: 1 year ]
  3. Sessile Serrated Lesions Per Colon [ Time Frame: 1 year ]
  4. False Neoplasia Rate [ Time Frame: 1 year ]
  5. Withdrawal Time [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior history of subtotal colectomy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05963724


Locations
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United States, California
Riverside University Health System
Moreno Valley, California, United States, 92555
Sponsors and Collaborators
Riverside University Health System Medical Center
More Information
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Publications:

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Responsible Party: Riverside University Health System Medical Center
ClinicalTrials.gov Identifier: NCT05963724    
Other Study ID Numbers: 1922564-2
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Riverside University Health System Medical Center:
artificial intelligence
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases