Adenoma Colon, Polyp Colorectal
Conditions
Brief summary
This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.
Interventions
DEVICEEW10-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.
Sponsors
Fujifilm Medical Systems USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
Patients will be randomized 1:1, inspection with computer assisted colonoscopy: inspection with conventional colonoscopy.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed