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CompletedNCT05963724CADUpdated Jul 27, 2023

Real-Time CAD for Colonic Neoplasia: A RCT

An interventional study of Real-Time Computer Aided Detection and Stanford Colonoscopy in Colorectal Cancer and Colorectal Neoplasms, sponsored by Riverside University Health System Medical Center. Completed at 1 site in United States. Open to participants aged 30 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Riverside University Health System Medical Center · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was Mar 2023, 3 years 6 months ago, and no results have been posted to the registry.
  • Registered 10 months after the study started (first participant enrolled Sep 2022, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
1,100
Allocation
Randomized
Ages
30 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer
  • Colorectal Neoplasms

Keywords

  • artificial intelligence
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 1,100 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Riverside University Health System Medical Center is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Prior history of subtotal colectomy
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
1,100 participants (actual)

Study arms

  • Experimental
    Real-Time Computer Aided Detection

    Device: Real-Time Computer Aided Detection

  • Active comparator
    Standard Colonoscopy

    Procedure: Stanford Colonoscopy

Interventions

  • DeviceReal-Time Computer Aided Detection

    This intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic)

  • ProcedureStanford Colonoscopy

    This involves white-light colonoscopy

06

What researchers measure

Primary outcomes

  1. Adenoma Detection Rate

    Time frame: 1 year

Secondary outcomes

  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

07

Study locations

1 site
  • Riverside University Health System
    Moreno Valley, California 92555, United States
08

References and documents

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. PubMed 36736437 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05963724
Lead sponsor
Riverside University Health System Medical Center
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Sep 1, 2022
Primary completion
Mar 31, 2023
Completion
May 27, 2023
Last update
Jul 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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