Musculoskeletal System Ultrasound Examination Data Collection Study for the Development of an Artificial Intelligence Software

NCT06025279 | Completed

• 1 other identifier: SMARTALPHA-CURIOUS-1000
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this observational study is to acquire ultrasound images (raw data) encompassing various planes within the musculoskeletal system. This data will be instrumental in the development of artificial intelligence-guided software. The study aims to enlist 300 volunteers, comprising individuals with both healthy musculoskeletal systems and those presenting pathologies. These participants will undergo ultrasound scans administered by two experienced professionals, employing FDA-cleared ultrasound devices. The main question it aims to answer is:

• Are the collected ultrasound images of diagnostic quality?

Conditions

Ultrasound Imaging of Anatomical Structures; Musculoskeletal Diseases

Keywords

Artificial Intelligence; Ultrasound Imaging; Musculoskeletal System; Data Collection

Outcome Measures

Primary Outcomes (1)

• Collecting ultrasound data for artificial intelligence software that highlighted structures

  The gathered images will serve the purpose of annotating anatomical landmarks, enabling the acquisition of diagnostically reliable images through artificial intelligence software. These annotated ultrasound images, validated by experts, will form the basis of a training dataset for the development of a machine learning algorithm.

  4 months

Secondary Outcomes (1)

• Assessment of image quality

  4 months

Interventions

Ultrasound Scan OTHER

Clinical professionals will conduct non-invasive ultrasound scans from the specified body views and subsequently save the acquired data.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 300 participants, divided between genders (150 females and 150 males), will take part in the study. These participants will include both healthy individuals and pathological conditions related to specific views of the musculoskeletal system. Their involvement will be based on informed consent. Pertinent data, such as medical history, body mass index (BMI), age, and gender, will be reported. The logistical expenses of the volunteers during the study will be covered by the sponsor, Smart Alfa Teknoloji San. ve Tic. A.Ş. The collection of raw ultrasound data will be undertaken by two experienced clinicians in physical medicine and rehabilitation, and ultrasound scanning. Their expertise ensures accurate data collection.

You may qualify if:

• Volunteers over the age of 18
• Able to accept and sign the Informed Consent Form before participating in the study

You may not qualify if:

• Volunteers below the age of 18
• Unwilling to accept or having psychiatric or neurological diseases to sign an Informed Consent Form before participating in the study
• Inability to lie flat
• Anatomical deformity in the area to be scanned

Sponsors & Collaborators

• Smart Alfa Teknoloji San. ve Tic. A.S.: lead
• Ankara University: collaborator

Study Sites (1)

Ankara University School of Medicine

Altındağ, Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (2)

• Gungor I, Gunaydin B, Buyukgebiz Yesil BM, Bagcaz S, Ozdemir MG, Inan G, Oktar SO. Evaluation of the effectiveness of artificial intelligence for ultrasound guided peripheral nerve and plane blocks in recognizing anatomical structures. Ann Anat. 2023 Oct;250:152143. doi: 10.1016/j.aanat.2023.152143. Epub 2023 Aug 11.

  PMID: 37572764 BACKGROUND

• Ozcakar L, Tok F, Ricci V, Mezian K, Wu CH, Wu WT, Park GY, Kwon DR, Prieto MG, Dughbaj M, Dogan Y, Aksoz B, Guvener O, Ekiz T, Tiras M, Karacoban L, Menderes Y, Ciftci E, Ilicepinar OF, Kaya U, Kara M, Chang KV. Artificial Intelligence Featuring EURO-MUSCULUS/USPRM Basic Scanning Protocols. Am J Phys Med Rehabil. 2022 Nov 1;101(11):e174-e175. doi: 10.1097/PHM.0000000000002070. Epub 2022 Jul 7. No abstract available.

  PMID: 35802706 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: August 3, 2023
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)