AI Colorectal Polyp Detection

Not Applicable

Completed

• Conditions: Polyp Colorectal; Adenoma Colon
• Interventions: Device: EW10-EC02 (Endoscopy Support Program)

• Registration Number: NCT04979962
• Lead Sponsor: Fujifilm Medical Systems USA, Inc.

Brief Summary

This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-28
• Study Start: 2021-11-24
• Primary Completion: 2022-09-30
• Study Completion: 2022-11-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1162

Inclusion Criteria

• Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)
• Patients aged 45 or older
• Patients who can provide an informed consent

Exclusion Criteria

• Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease
• Patients who are pregnant or are planning pregnancy during study period
• Patients who are not able to or refuse to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CAC Group	EW10-EC02 (Endoscopy Support Program)	Inspection with computer assisted colonoscopy.

Primary Outcome Measures

Name	Time	Method
Adenoma per colonoscopy (APC)	1 day/procedure	Total number of histologically confirmed adenomas and carcinomas detected in the colonoscopy divided by the total number of colonoscopies

Secondary Outcome Measures

Name	Time	Method
Positive predictive value (PPV)	1 day/procedure	Total number of histologically confirmed adenomas and carcinomas detected during the colonoscopy, divided by the total number of excisions in the colonoscopy
Adenoma detection rate (ADR)	1 day/procedure	proportion of patients with at least one histologically confirmed adenoma or carcinoma detected in the colonoscopy

Trial Locations

Locations (10)

Brigham and Women's Hospital; 🇺🇸 Chestnut Hill, Massachusetts, United States

Kansas City VA Medical Center; 🇺🇸 Kansas City, Missouri, United States

Largo Medical Center (HCA); 🇺🇸 Largo, Florida, United States

New York University/Manhattan Endoscopy; 🇺🇸 New York, New York, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

GI Associates; 🇺🇸 Flowood, Mississippi, United States

Keck Medicine University of Southern California; 🇺🇸 Los Angeles, California, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Saint Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States