Clinical Validation of Nerveblox, an Artificial Intelligence Software to Support Ultrasound-Guided Regional Anesthesia Procedures

Data Collection for the Validation of an AI Software to Support Ultrasound-Guided Regional Anesthesia Procedures

This single-center, prospective study is being conducted at AABP Integrative Pain Care and Wellness in Brooklyn, New York, USA. The aim of this study is to collect ultrasound images from healthy volunteers and evaluate the performance of the Nerveblox software using this image dataset. Nerveblox is a software as a medical device which is designed to assist anesthesiologist for ultrasound-guided regional anesthesia, prior to needling procedure.

Study Overview

• Status: Completed
• Conditions: Ultrasound Imaging of Anatomical Structures
• Intervention / Treatment: Device: Ultrasound Scans

Detailed Description

This study aims to validate the performance of AI technology in regional anesthesia through a clinical evaluation conducted on the U.S. population.

Data collection method and Analysis:

A total of 40 healthy subjects were enrolled and scanned by three different expert anesthesiologists. Twelve different peripheral nerve and plane block regions supported by the Nerveblox software were scanned bilaterally. Each participant spent approximately 30 minutes in the ultrasound scanning session, with each ultrasound clip lasting 10 seconds.

Age, gender, weight, and height data were collected and reported for each subject. Subjects were selected to balance the BMI distribution between those with BMI < 30 kg/m² and those with BMI ≥ 30 kg/m². An FDA-cleared, commercially available ultrasound device was used during the scanning process, and the Nerveblox software was not utilized in the data collection sessions.

Collected ultrasound clips included both ideal and non-ideal block views. The collected ultrasound scans were processed post hoc by the Nerveblox software, and the resulting outputs, alongside the raw ultrasound images, will be assessed by a panel of expert anesthesiologists. These clips were reviewed by two separate groups of reviewers, each consisting of three members.

Reviewers were asked to evaluate:

• Highlighting of Safety-Critical Anatomical Structures: For each safety-critical anatomical landmark on each clip, the majority opinion (at least 2 out of 3) was used to determine the overall panel results.
• Image Quality: Experts rated image quality on a scale from 1 to 5. These results were then converted to a binary measure for analysis.
• Effect of color highlighting on the perceived risks of ultrasound-guided regional anesthesia

Data were expressed as frequencies and shown as a percentage of the total clips analyzed. Inter-rater agreement was reported by block region.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11204
      • AABP Integrative Pain Care and Wellness Clinic

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form
• 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?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Performance assessment of anatomical landmark detection and highlighting of Nerveblox Software	The proportion of structures correctly identified by the software to all structures	Up to 35 days from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality assessment	The agreement assesment between the Nerveblox Software's image quality grading and experts opinion for image quality	Up to 35 days from enrollment

Collaborators and Investigators

• Sponsor: Smart Alfa Teknoloji San. ve Tic. A.S.
• Investigators: Principal Investigator: Gary Scott Shwartz, M.D., AABP Integrative Pain Care and Wellness Clinic, Brooklyn

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Actual): February 23, 2025
• Study Completion (Actual): February 23, 2025

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Regional Anesthesia
• Other Study ID Numbers: NRV-001-05

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