Ultrasound Imaging of Anatomical StructuresNCT07336407
Data Collection for the Validation of an Artificial Intelligence Software to Support Musculoskeletal Ultrasound Examination
A study testing Ultrasound Scans in people with Ultrasound Imaging of Anatomical Structures, run by Smart Alfa Teknoloji San. ve Tic. A.S. at 3 sites in United States.
Trial summary
This study conducted at three locations, aiming to collect ultrasound images from volunteers and assess the performance of an AI software, MSK Go, using these images. The software to be assessed is designed to assist physicians and healthcare professionals in performing ultrasound exams by classifying scan views and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Imaging of Anatomical Structures
- What is being tested?
- Ultrasound Scans
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2025to 30 Nov 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of a signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- Pregnancy
- Inability to lie flat
- Open skin lesions or active infection at the scan site
- Anatomical deformity in the joints to be scanned
Trial locations and contacts
3 sites in 1 country.
United States3 sites
AABP Integrative Pain Care and Wellness Clinic
Brooklyn, New York, 11204
Scripps Clinic Torrey Pines
La Jolla, California, 92037
Memorial Hermann Houston Health & Sports Medicine
Woodland, Texas, 77380
About this study
Official title: Data Collection for the Validation of an AI Software to Support MSK Ultrasound Examination
This study conducted at three locations, aiming to collect ultrasound images from volunteers and assess the performance of an AI software, MSK Go, using these images.
The software to be assessed is designed to assist physicians and healthcare professionals in performing ultrasound exams by classifying scan views and identifying key anatomical structures during a musculoskeletal ultrasound examination.
The main question the study aims to answer is whether the AI software performs safely and effectively for future clinical use.
Read the detailed description
This study is designed to validate the performance of the MSK Go software in classifying musculoskeletal ultrasound examination views and segmenting relevant anatomical structures in a U.S. population.
Data collection method and analysis:
A total of 79 subjects were enrolled and undergone shoulder, elbow, wrist/hand, knee, and foot/ankle scans at three clinical sites. Ultrasound examinations were performed by MSK ultrasound experts without using MSK Go.
Each participant spent approximately 30 minutes in the ultrasound scanning session. Demographic data were collected for all subjects. An FDA-cleared, commercially available ultrasound device was used at each location.
The collected ultrasound scans are then annotated by healthcare professionals with expertise in musculoskeletal sonography.
In a post hoc analysis, the ultrasound clips were processed using the AI software, and the software-generated classifications of views and segmentations of anatomical structures were compared with the reference annotations .
Convenience sampling was applied during data collection to ensure that participants represented a balanced distribution across age, gender, BMI, and ethnicity.
- Being tested
- Ultrasound Scans
- Keywords
- Musculoskeletal, Artificial Intelligence, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ScansDevice
Scanning for musculoskeletal examination views on shoulder, elbow, wrist/hand, knee, and foot/ankle.
| Study group | Role | What they receive |
|---|---|---|
| U.S population | Other | Not described Receives: Device: Ultrasound Scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of spatial (area) overlap of anatomical structure areas on the ultrasound image
The performance based on the rate of the spatial (area) overlapping of supported structures
Measured: Up to 30 days from enrollment
Rae of correctly classifying the views of the joint
The performance based on the rate of correctly detecting views of the selected joint
Measured: Up to 30 days from enrollment
Secondary outcomes (1)
Rate of correctly assigning anatomical structure completeness level for any scan view of the joint
The performance based on the completeness rate of detection level of the set of supported anatomical structures by the software
Measured: Up to 30 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Sep 2025
- Primary completion31 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Imaging of Anatomical StructuresStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smart Alfa Teknoloji San. ve Tic. A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336407
- Sponsor's protocol ID
- MSK-001-02
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for the Validation of an AI Software to Support MSK Ultrasound Examination
- ClinicalTrials.gov ID
- NCT07336407
- Acronym / sponsor ID
- MSK-001-02
- Keywords
- Musculoskeletal, Artificial Intelligence, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Smart Alfa Teknoloji San. ve Tic. A.S.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 13 Jan 2026 (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.
This study conducted at three locations, aiming to collect ultrasound images from volunteers and assess the performance of an AI software, MSK Go, using these images.
The software to be assessed is designed to assist physicians and healthcare professionals in performing ultrasound exams by classifying scan views and identifying key anatomical structures during a musculoskeletal ultrasound examination.
The main question the study aims to answer is whether the AI software performs safely and effectively for future clinical use.
Detailed description
This study is designed to validate the performance of the MSK Go software in classifying musculoskeletal ultrasound examination views and segmenting relevant anatomical structures in a U.S. population.
Data collection method and analysis:
A total of 79 subjects were enrolled and undergone shoulder, elbow, wrist/hand, knee, and foot/ankle scans at three clinical sites. Ultrasound examinations were performed by MSK ultrasound experts without using MSK Go.
Each participant spent approximately 30 minutes in the ultrasound scanning session. Demographic data were collected for all subjects. An FDA-cleared, commercially available ultrasound device was used at each location.
The collected ultrasound scans are then annotated by healthcare professionals with expertise in musculoskeletal sonography.
In a post hoc analysis, the ultrasound clips were processed using the AI software, and the software-generated classifications of views and segmentations of anatomical structures were compared with the reference annotations .
Convenience sampling was applied during data collection to ensure that participants represented a balanced distribution across age, gender, BMI, and ethnicity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U.S population | Other | Device: Ultrasound Scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Provision of a signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Key exclusion criteria (4 listed)
- Pregnancy
- Inability to lie flat
- Open skin lesions or active infection at the scan site
- Anatomical deformity in the joints to be scanned
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 |
|---|---|---|
| Ultrasound ScansScanning for musculoskeletal examination views on shoulder, elbow, wrist/hand, knee, and foot/ankle. | Device | U.S population |
Primary outcome
Rate of spatial (area) overlap of anatomical structure areas on the ultrasound image
Time frame: Up to 30 days from enrollment
The performance based on the rate of the spatial (area) overlapping of supported structures
Rae of correctly classifying the views of the joint
Time frame: Up to 30 days from enrollment
The performance based on the rate of correctly detecting views of the selected joint
1 secondary outcome
Rate of correctly assigning anatomical structure completeness level for any scan view of the joint
Time frame: Up to 30 days from enrollment
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 13 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Scans in people with Ultrasound Imaging of Anatomical Structures, run by Smart Alfa Teknoloji San. ve Tic. A.S. at 3 sites 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 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Rate of spatial (area) overlap of anatomical structure areas on the ultrasound image (time frame: Up to 30 days from enrollment). The study lists 2 primary outcomes in all. 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 13 Jan 2026.