Clinical Validation of Boneview for FDA Submission

Fracture Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532580
• Other study ID #: BCK-CEP
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: July 26, 2021

Study information

• Verified date: August 2021
• Source: Gleamer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: July 26, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
United States	Boston Imaging Core Lab	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Gleamer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of diagnosis performances via calculation of sensitivity, specificity, NPV, PPV	calculation of sensitivity, specificity, NPV, PPV and comparison between the two cohorts	1 month
Secondary	Time needed for diagnosis via measurement of the time before submission of the diagnosis	measurement of the time and comparison between the two cohorts	1 month