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Data Collection for the Validation of an Artificial Intelligence Software to Support Musculoskeletal Ultrasound Examination

S

Smart Alfa Teknoloji

Status

Completed

Conditions

Ultrasound Imaging of Anatomical Structures

Treatments

Device: Ultrasound Scans

Study type

Interventional

Funder types

Industry

Identifiers

NCT07336407
MSK-001-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnancy
  • Inability to lie flat
  • Open skin lesions or active infection at the scan site
  • Anatomical deformity in the joints to be scanned

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

79 participants in 1 patient group

U.S population
Other group
Treatment:
Device: Ultrasound Scans

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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