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OpenTrials
Completed

NCT Number: NCT04532580

Clinical Validation of Boneview for FDA Submission

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).

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Key information

Conditions

Fracture Fractures, Bone Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Imaging Core Lab

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnosis of fracture on X-Ray Radiographs

Device

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

Primary outcomes

  1. measurement of diagnosis performances via calculation of sensitivity, specificity, NPV, PPV

    Time frame: 1 month

    calculation of sensitivity, specificity, NPV, PPV and comparison between the two cohorts

Secondary outcomes

  1. Time needed for diagnosis via measurement of the time before submission of the diagnosis

    Time frame: 1 month

    measurement of the time and comparison between the two cohorts

Sponsors and collaborators

Lead sponsor

Gleamer

Industry

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2020
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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