Clinical trial NCT04532580: Clinical Validation of Boneview for FDA Submission
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture
Keywords: fracture
artificial intelligence
x-rays radiographs
Lead sponsor: Gleamer
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 480
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cases are consecutively sampled considering (non-)inclusion criteria (see below), and following these constraints:

* At least 60 exams for the foot/ankle region, 60 exams for the knee/leg region, 60 exams for the hip/pelvis region, 60 exams for the hand/wrist region, 60 exams for the elbow/arm region, 60 exams for the shoulder/clavicula region, 60 exams of the rib cage region, 60 exams of the dorsolumbar spine region
* 50% of exams of each region being positive: namely presenting one or multiple fracture(s) and 50% of exams of each region being negative: namely presenting no fracture
* 50% of positive exams of each anatomical region presenting at least a "non-obvious" fracture and 50% with only "obvious" fracture(s). The determination of the "obvious" and "non-obvious" nature of the fractures would be determined during the Ground Truth determination process. The two osteo-articular experts that are performing the Ground Truth have to state the nature of the fracture.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: measurement of diagnosis performances via calculation of sensitivity, specificity, NPV, PPV
timeFrame: 1 month
Secondary outcomes:
measure: Time needed for diagnosis via measurement of the time before submission of the diagnosis
timeFrame: 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Imaging Core Lab
state: Massachusetts
Study officials:
affiliation: Gleamer
name: Nor-Eddine Regnard, MD
role: STUDY_CHAIR
References: