Trials / Completed
CompletedNCT04532580
Clinical Validation of Boneview for FDA Submission
Clinical Validation of Boneview for FDA Submission: Evaluation of the Ability of the Artificial Intelligence Software, Boneview, to Improve Physicians' and Radiologists' Performances in Detecting Fractures on Bone X-Rays Radiographs.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 480 (actual)
- Sponsor
- Gleamer · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
The goal of this clinical validation is to assess comparative performances of physicians with and without the assistance of BoneView for the diagnosis of fractures on radiographs. The performances are evaluated in terms of accuracy (primary endpoint with the pair specificity/sensitivity and the secondary endpoint PPV/NPV) and in terms of time needed for diagnosis (secondary endpoint with the measurement of time on each case).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Diagnosis of fracture on X-Ray Radiographs | Diagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2021-05-10
- Completion
- 2021-07-26
- First posted
- 2020-08-31
- Last updated
- 2021-08-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04532580. Inclusion in this directory is not an endorsement.