Ultrasound Image Collection for the Development of an AI Software

Data Collection for the Development of Artificial Intelligence (AI) Software to Support Ultrasound-Guided Regional Anesthesia Procedures

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

Study Overview

• Status: Completed
• Conditions: Ultrasound Scan
• Intervention / Treatment: Device: Ultrasound scans

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 Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78752
      • Conference Room at Doubletree by Hilton Austin

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

volunteers from the U.S. population

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
U.S. population	Device: Ultrasound scans; 10 seconds scanning for one block region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ultrasound scan recordings relevant to peripheral nerve blocks collected	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.	Day 1, 2 and 3

Collaborators and Investigators

• Sponsor: Smart Alfa Teknoloji San. ve Tic. A.S.
• Investigators: Principal Investigator: Senanur Samur Duysal, Smart Alfa Teknoloji San. ve Tic. A.S.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Regional Anesthesia; Data collection
• Other Study ID Numbers: NRV-001-04

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: Yes
• product manufactured in and exported from the U.S.: No