Trials / Completed
CompletedNCT04979962
AI Colorectal Polyp Detection
Colorectal Polyp Detection Comparing Computer Assisted Colonoscopy With Conventional Colonoscopy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,162 (actual)
- Sponsor
- Fujifilm Medical Systems USA, Inc. · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Accepted
Summary
This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-11-24
- Primary completion
- 2022-09-30
- Completion
- 2022-11-21
- First posted
- 2021-07-28
- Last updated
- 2023-09-18
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04979962. Inclusion in this directory is not an endorsement.