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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

Tracking Information
First Submitted Date August 25, 2020
First Posted Date August 31, 2020
Last Update Posted Date August 12, 2021
Actual Study Start Date September 1, 2020
Actual Primary Completion Date May 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 6, 2021)
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
Original Primary Outcome Measures
 (submitted: August 25, 2020)
measurement of diagnosis performances [ Time Frame: 1 month ]
calculation of sensitivity, specificity, NPV, PPV
Change History
Current Secondary Outcome Measures
 (submitted: August 6, 2021)
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
Original Secondary Outcome Measures
 (submitted: August 25, 2020)
Time needed for diagnosis [ Time Frame: 1 month ]
measurement of the time
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Fracture
Intervention Device: Diagnosis of fracture on X-Ray Radiographs
Diagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software
Study Groups/Cohorts
  • AI- Aided performances
    Intervention: Device: Diagnosis of fracture on X-Ray Radiographs
  • AI- Unaided performances
    Intervention: Device: Diagnosis of fracture on X-Ray Radiographs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 25, 2020)
480
Original Estimated Enrollment Same as current
Actual Study Completion Date July 26, 2021
Actual Primary Completion Date May 10, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04532580
Other Study ID Numbers BCK-CEP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: no sharing of our IPD
Current Responsible Party Gleamer
Original Responsible Party Same as current
Current Study Sponsor Gleamer
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Chair: Nor-Eddine Regnard, MD Gleamer
PRS Account Gleamer
Verification Date August 2021