FractureNCT04532580
Clinical Validation of Boneview for FDA Submission
An observational study of Fracture, run by Gleamer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fracture
- What is being tested?
- Diagnosis of fracture on X-Ray Radiographs
- Type of treatment
- Medical device
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 26 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Imaging Core Lab
Boston, Massachusetts, 02118
About this study
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.
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).
- Conditions
- Fracture
- Being tested
- Diagnosis of fracture on X-Ray Radiographs
- Keywords
- fracture, artificial intelligence, x-rays radiographs
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of fracture on X-Ray RadiographsDevice
Diagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software
| Study group | Role | What they receive |
|---|---|---|
| AI- Aided performances | Not described Receives: Device: Diagnosis of fracture on X-Ray Radiographs | |
| AI- Unaided performances | Not described Receives: Device: Diagnosis of fracture on X-Ray Radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of diagnosis performances via calculation of sensitivity, specificity, NPV, PPV
calculation of sensitivity, specificity, NPV, PPV and comparison between the two cohorts
Measured: 1 month
Secondary outcomes (1)
Time needed for diagnosis via measurement of the time before submission of the diagnosis
measurement of the time and comparison between the two cohorts
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Sep 2020
- Primary completion10 May 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gleamer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nor-Eddine Regnard, MD, Study chair, Gleamer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532580
- Sponsor's protocol ID
- BCK-CEP
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2020
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: no sharing of our IPD
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04532580
- Acronym / sponsor ID
- BCK-CEP
- Conditions
- Fracture
- Keywords
- fracture, artificial intelligence, x-rays radiographs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- GleamerIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI- Aided performances | – | Device: Diagnosis of fracture on X-Ray Radiographs |
| AI- Unaided performances | – | Device: Diagnosis of fracture on X-Ray Radiographs |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of fracture on X-Ray RadiographsDiagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software | Device | AI- Aided performances, AI- Unaided performances |
Primary outcome
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
1 secondary outcome
Time needed for diagnosis via measurement of the time before submission of the diagnosis
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: No. no sharing of our IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nor-Eddine Regnard, MD study chair
Gleamer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture, run by Gleamer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of diagnosis performances via calculation of sensitivity, specificity, NPV, PPV (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.