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Clinical Validation of Boneview for FDA Submission

NCT04532580 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 480

Last updated 2021-08-12

No results posted yet for this study

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

  • Fracture

Interventions

DEVICE

Diagnosis of fracture on X-Ray Radiographs

Diagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software

Sponsors & Collaborators

  • Gleamer

    lead INDUSTRY

Principal Investigators

  • Nor-Eddine Regnard, MD · Gleamer

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-05-10
Completion
2021-07-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532580 on ClinicalTrials.gov