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

Data Collection Study to Develop an Artificial Intelligence-Based Ultrasound Guidance Software (Curious) for Musculoskeletal Examinations

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?

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Diseases; Ultrasound Imaging of Anatomical Structures
• Intervention / Treatment: Other: Ultrasound Scan

Detailed Description

Ultrasound's cost-effective and user-friendly attributes have positioned it as a cornerstone in diagnosing musculoskeletal system disorders.

In this single-centered and prospective study, the study aims to enlist 300 volunteers, comprising both individuals with healthy musculoskeletal systems and those with pathologies. The collected ultrasound raw data will be used to train models for the identification and highlighting of key anatomical landmarks on ultrasound images. Participants' gender, age, BMI, and medical history will be considered and reported. All scans will be performed on FDA-cleared general-purpose ultrasound devices. Obtained images will be used to develop artificial intelligence-based medical software by Smart Alfa Teknoloji San. Ve Tic. A.Ş., Ankara, Turkey. Smart Alfa has similarly conducted a study in the field of anesthesia using the same method in Nerveblox artificial intelligence software.

The study methodology encompasses the following components:

• Specific body views, guided by established protocols, will be scanned from different body planes. The focus areas encompass musculoskeletal structures.
• A cohort of 300 volunteers, evenly distributed by gender (150 male, 150 female), will have their demographic data (BMI, gender, age) documented.
• To counteract potential biases, the sequence of volunteer participation will be randomized.
• Each scan is expected to take 45 minutes.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

• Study Contact: Name: Utku Kaya; Phone Number: 90 530 386 94 35; Email: utku.kaya@smartalpha.ai
• Study Contact Backup: Name: Cem Volkan Dogan; Phone Number: 90 532 73652 06; Email: volkan.dogan@smartalpha.ai

Study Locations

• Turkey
  • Ankara
    • Altındağ, Ankara, Turkey, 06230
      • Ankara University School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of image quality	The usability of the collected data in the artificial intelligence software will be verified.	4 months

Collaborators and Investigators

• Sponsor: Smart Alfa Teknoloji San. ve Tic. A.S.
• Collaborators: Ankara University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Musculoskeletal System; Ultrasound Imaging; Data Collection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: SMARTALPHA-CURIOUS-1000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No