AI Colorectal Polyp Detection

Fujifilm Medical Systems USA, Inc.1,162 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

1,162

Conditions

Polyp Colorectal Adenoma Colon

Interventions

EW10-EC02 (Endoscopy Support Program)DEVICE

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.

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Keck Medicine University of Southern California

Los Angeles, California, United States

Largo Medical Center (HCA)

Largo, Florida, United States

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

Outcomes

Primary Outcomes

Adenoma per colonoscopy (APC)

Total number of histologically confirmed adenomas and carcinomas detected in the colonoscopy divided by the total number of colonoscopies

Time frame: 1 day/procedure

Secondary Outcomes

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

Time frame: 1 day/procedure

Adenoma detection rate (ADR)

proportion of patients with at least one histologically confirmed adenoma or carcinoma detected in the colonoscopy

Time frame: 1 day/procedure

Data from ClinicalTrials.gov

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