Clinical Validation of Boneview for FDA Submission

Completed

Conditions studied: Fracture

In brief

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).

Key facts

Study ID

NCT04532580

Run by

Gleamer

People needed

480

Starts

2020-09-01

Expected to finish

2021-07-26

Last updated by the study team

2021-08-12

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Anonymized standard X-ray exams of extremity/pelvis/rib cage/dorsolumbar spine not containing or containing fracture(s).
• Adult patient, with minimum age of 21 years old.

You may not qualify if…

• Exams with one or more images including a body part not concerned by the intended use of BoneView (skull and cervical spine)
• Cases with one or more images being used for model design and development.
• Exams with one or more images being of poor quality (lossy), which prevent a proper interpretation by the readers.
• Cases not containing a medically relevant number of views for correct diagnosis.

Where it is running

• Boston Imaging Core Lab — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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