AI Colorectal Polyp Detection

Adenoma Colon Clinical Trial

Official title:

Colorectal Polyp Detection Comparing Computer Assisted Colonoscopy With Conventional Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04979962
• Other study ID #: P-21-006
• Status: Completed
• Phase: N/A
• Start date: November 24, 2021
• Est. completion date: November 21, 2022

Study information

• Verified date: September 2023
• Source: Fujifilm Medical Systems USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1162
• Est. completion date: November 21, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Polyp Colorectal
• Polyps

Intervention

Device:
• EW10-EC02 (Endoscopy Support Program)
EW10-EC02 is intended to automatically detect the location of suspected polyps in colonoscopy exams. Identified polyps are highlighted to the clinician in real-time during the exam, as a video image superimposed on the endoscope monitor. EW10-EC02 is limited to the detection of suspected findings, and should not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts
United States	GI Associates	Flowood	Mississippi
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Largo Medical Center (HCA)	Largo	Florida
United States	Keck Medicine University of Southern California	Los Angeles	California
United States	Columbia University Medical Center	New York	New York
United States	New York University/Manhattan Endoscopy	New York	New York
United States	Swedish Medical Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fujifilm Medical Systems USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma per colonoscopy (APC)	Total number of histologically confirmed adenomas and carcinomas detected in the colonoscopy divided by the total number of colonoscopies	1 day/procedure
Secondary	Positive predictive value (PPV)	Total number of histologically confirmed adenomas and carcinomas detected during the colonoscopy, divided by the total number of excisions in the colonoscopy	1 day/procedure
Secondary	Adenoma detection rate (ADR)	proportion of patients with at least one histologically confirmed adenoma or carcinoma detected in the colonoscopy	1 day/procedure