Artificial Intelligence in Colonoscopy

Not Applicable

Completed

• Conditions: Colorectal Carcinoma
• Interventions: Device: Artificial Intelligence; Device: Mucosal Exposure Device

• Registration Number: NCT06621225
• Lead Sponsor: Pankaj Patel

Brief Summary

N = 264 patients (50% female) aged 75 years and above undergoing colonoscopy were enrolled. Patients were randomly assigned into one of the three intervention groups: the primary intervention arm (CADe in combination with the MED), the second group with MED alone, and the control group with WLE. All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was the adenoma detection rate. Secondary outcomes were adenoma detection in the left colon in our cohort of patients.

Detailed Description

264 patients, with an equal gender distribution (50% female), aged 75 years and above, undergoing screening and diagnostic colonoscopy at The Surgery and Endoscopy Center of Sebring, Sebring, Florida, were enrolled in this study. The eligibility criteria for a randomized controlled trial (RCT) comparing AI and mucosal exposure devices together, mucosal exposure devices alone, and white light endoscopy in patients 75 years and older could be structured as follows.

Patients were randomly allocated into one of three study groups: the primary intervention arm, where colonoscopy was performed using the CADe in combination with the MED; the second group underwent colonoscopy solely with the MED, while the control group underwent colonoscopy solely with the WLE. We used a Convolutional Neural Network-based CADe system, GI Genius, acquired for licensed use from Medtronic Inc., Minneapolis, MN. The MED employed was the EndoCuff Vision (ECV) developed by Olympus America, Center Valley, PA, which constitutes part of the standard equipment available. All detected lesions were identified and excised throughout the colonoscopy procedures, and specimens were promptly sent for histopathological analysis.

The primary outcome of interest was adenoma detection rate (ADR), defined as the percentage of patients in whom at least one histologically proven adenoma or carcinoma was identified during colonoscopy. Secondary outcomes included ADR in the left colon in our cohort of patients.

This study was conducted according to accepted ethical principles and approved by the institutional review board (IRB) of "The Surgery and Endoscopy Center of Sebring.\" Informed consent was obtained from all participants before enrollment, and measures were taken to ensure patient confidentiality and data protection throughout the study period.

Study Timeline

• Study Start: 2022-11-22
• Primary Completion: 2023-05-31
• Study Completion: 2023-06-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-07
• Study First Submitted QC: 2024-09-28
• Last Update Submitted: 2024-09-28
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Intervention Arm	Artificial Intelligence	In this arm, colonoscopy was performed using Computer Aided detection in combination with a Mucosal Exposure Device, which is FDA approved.
Primary Intervention Arm	Mucosal Exposure Device	In this arm, colonoscopy was performed using Computer Aided detection in combination with a Mucosal Exposure Device, which is FDA approved.
Secondary Intervention Arm	Mucosal Exposure Device	In this arm, participants underwent colonoscopy solely with an FDA approved Mucosal Exposure Device

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure	181 days	The primary outcome of interest was adenoma detection rate (ADR), defined as the percentage of patients in whom at least one histologically proven adenoma or carcinoma was identified during colonoscopy.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measure	181 days	Secondary outcomes included Adenoam Detection Rate in the left colon in our cohort of patients.

Trial Locations

Locations (1)

The Surgery and Endoscopy Center of Sebring; 🇺🇸 Sebring, Florida, United States