Ultrasound Image Collection for the Development of an AI Software

Completed

• Conditions: Ultrasound Scan

• Registration Number: NCT06920277
• Lead Sponsor: Smart Alfa Teknoloji San. ve Tic. A.S.

Brief Summary

This study is designed to collect ultrasound images from healthy volunteers in the U.S.

Detailed Description

The goal of this study is to create an ultrasound image dataset of healthy volunteers from the U.S. population. This dataset will be used for development of an AI software which will assist anesthesiologists in detection of key anatomical structures on the ultrasound image for peripheral nerve block applications. These blocks are:

* Interscalene Brachial Plexus

* Supraclavicular Brachial Plexus

* Infraclavicular Brachial Plexus

* Cervical Plexus

* Axillary Brachial Plexus

* PECS I \& II

* Transversus Abdominis Plane (TAP)

* Rectus Sheath

* Femoral Nerve

* Adductor Canal

* Popliteal Sciatic

* Erector Spinae Plane (ESP)

Study Timeline

• Study Start: 2024-10-29
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Study First Submitted: 2025-03-25
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Provision of signed and dated informed consent form
• At least 18 years of age and older
• Stated willingness to comply with all study procedures and availability for the duration of the study
• In good general health

Exclusion Criteria

• Pregnancy
• Inability to lie to flat
• Any complaint or anatomical deformity on the regions to be scanned

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of ultrasound scan recordings relevant to peripheral nerve blocks collected	Day 1, 2 and 3	Ultrasound scans will be collected and reviewed for quality and completeness. The outcome will be the number of ultrasound recordings that meet predefined criteria for image quality; correct anatomical region and clear visualization to support AI development.

Trial Locations

Locations (1)

Conference Room at Doubletree by Hilton Austin; 🇺🇸 Austin, Texas, United States