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Clinical Validation of Boneview for FDA Submission

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04532580
Recruitment Status : Completed
First Posted : August 31, 2020
Last Update Posted : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment
Fracture Device: Diagnosis of fracture on X-Ray Radiographs

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Study Type : Observational
Actual Enrollment : 480 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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.
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : May 10, 2021
Actual Study Completion Date : July 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures X-Rays
Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04532580


Locations
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United States, Massachusetts
Boston Imaging Core Lab
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Gleamer
Investigators
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Study Chair: Nor-Eddine Regnard, MD Gleamer
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Responsible Party: Gleamer
ClinicalTrials.gov Identifier: NCT04532580    
Other Study ID Numbers: BCK-CEP
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no sharing of our IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gleamer:
fracture
artificial intelligence
x-rays radiographs
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries