Purpose

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).

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
AI- Aided performances
  • Device: Diagnosis of fracture on X-Ray Radiographs
    Diagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software
AI- Unaided performances
  • Device: Diagnosis of fracture on X-Ray Radiographs
    Diagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software

Recruiting Locations

Boston Imaging Core Lab
Boston, Massachusetts 02118
Contact:
Ali Guermazi, MD PhD
617-584-6851
guermazi@bu.edu

More Details

Status
Recruiting
Sponsor
Gleamer

Study Contact

Nor-Eddine Regnard, MD
0033610200550
noreddine.regnard@gleamer.ai

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.