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Real-Time CAD for Colonic Neoplasia: A RCT

Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05963724
Acronym
CAD
Enrollment
1100
Registered
2023-07-27
Start date
2022-09-01
Completion date
2023-05-27
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Colorectal Neoplasms

Keywords

artificial intelligence

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.

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

Sponsors

Riverside University Health System Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Undergoing colonoscopy at RUHS * Age \> 45 years * No contraindications to colonoscopy

Exclusion criteria

* Prior history of subtotal colectomy

Design outcomes

Primary

MeasureTime frame
Adenoma Detection Rate1 year

Secondary

MeasureTime frame
Adenomas Per Colon1 year
Sessile Serrated Lesion Detection Rate1 year
Sessile Serrated Lesions Per Colon1 year
False Neoplasia Rate1 year
Withdrawal Time1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026