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OpenTrials
Completed

NCT Number: NCT06025279

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

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University School of Medicine

Altındağ, Ankara, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound scan

Other

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

Primary outcomes

  1. Collecting ultrasound data for artificial intelligence software that highlighted structures

    Time frame: 4 months

    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.

Secondary outcomes

  1. Assessment of image quality

    Time frame: 4 months

    The usability of the collected data in the artificial intelligence software will be verified.

Sponsors and collaborators

Lead sponsor

Smart Alfa Teknoloji San. ve Tic. A.S.

Industry

Collaborators

  • Ankara University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2023
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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