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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04979962
Other study ID # P-21-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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