Clinical Validation of Boneview for FDA Submission

• ClinicalTrials.gov Identifier: NCT04532580
• Recruitment Status: Completed
• First Posted: August 31, 2020
• Last Update Posted: August 12, 2021
• Sponsor: Gleamer
• 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

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

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

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