Clinical Validation of Boneview for FDA Submission

Completed

• Conditions: Fracture
• Interventions: Device: Diagnosis of fracture on X-Ray Radiographs

• Registration Number: NCT04532580
• Lead Sponsor: Gleamer

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-31
• Study Start: 2020-09-01
• Primary Completion: 2021-05-10
• Study Completion: 2021-07-26
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AI- Aided performances	Diagnosis of fracture on X-Ray Radiographs	-
AI- Unaided performances	Diagnosis of fracture on X-Ray Radiographs	-

Primary Outcome Measures

Name	Time	Method
measurement of diagnosis performances via calculation of sensitivity, specificity, NPV, PPV	1 month	calculation of sensitivity, specificity, NPV, PPV and comparison between the two cohorts

Secondary Outcome Measures

Name	Time	Method
Time needed for diagnosis via measurement of the time before submission of the diagnosis	1 month	measurement of the time and comparison between the two cohorts

Trial Locations

Locations (1)

Boston Imaging Core Lab; 🇺🇸 Boston, Massachusetts, United States