Real-Time CAD for Colonic Neoplasia: A RCT

• Sponsor: Riverside University Health System Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT05963724
• Collaborator: (none)
• Enrollment: 1,100
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 124.9

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Sep 1, 2022
• Actual Primary Completion Date: Mar 31, 2023
• Actual Study Completion Date: May 27, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Adenoma Detection Rate [1 year]

Secondary Outcome Measures

1. Adenomas Per Colon [1 year]

2. Sessile Serrated Lesion Detection Rate [1 year]

3. Sessile Serrated Lesions Per Colon [1 year]

4. False Neoplasia Rate [1 year]

5. Withdrawal Time [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Undergoing colonoscopy at RUHS

• Age > 45 years

• No contraindications to colonoscopy

Exclusion Criteria:

• Prior history of subtotal colectomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riverside University Health System	Moreno Valley	California	United States	92555

Sponsors and Collaborators

• Riverside University Health System Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Riverside University Health System Medical Center
• ClinicalTrials.gov Identifier: NCT05963724
• Other Study ID Numbers: 1922564-2
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Colorectal Neoplasms

Study Results

No Results Posted as of Jul 27, 2023