Clinical Validation of Boneview for FDA Submission | NCT04532580

Studies
Clinical Validation of Boneview for FDA Submission

NCT04532580

Sponsor

Gleamer

Status

Completed

Last Update Posted

Aug 12, 2021Actual

Enrollment

480Actual

Phase

Not provided

Conditions

Fracture

Interventions

Diagnosis of fracture on X-Ray Radiographs

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

May 10, 2021Actual

Completion Date

Jul 26, 2021Actual

First Submitted Date

Aug 25, 2020

First Submission Date that Met QC Criteria

Aug 25, 2020

First Posted Date

Aug 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2021

Last Update Posted Date

Aug 12, 2021Actual

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

480Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AI- Aided performances			Device: Diagnosis of fracture on X-Ray Radiographs
AI- Unaided performances			Device: Diagnosis of fracture on X-Ray Radiographs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnosis of fracture on X-Ray Radiographs	Device	Diagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software	AI- Aided performances

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
measurement of diagnosis performances via calculation of sensitivity, specificity, NPV, PPV	calculation of sensitivity, specificity, NPV, PPV and comparison between the two cohorts	1 month

Secondary Outcomes

Measure	Description	Time Frame
Time needed for diagnosis via measurement of the time before submission of the diagnosis	measurement of the time and comparison between the two cohorts	1 month

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample