NCT06878911

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 7, 2025

Last Update Submit

March 10, 2025

Conditions

Ultrasound Imaging of Anatomical Structures

Keywords

Artificial IntelligenceRegional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Image quality assessment

    Up to 35 days from enrollment

Study Arms (1)

U.S. Population

OTHER
Device: Ultrasound Scans

Interventions

Ultrasound ScansDEVICE

10 seconds scanning for one block region

U.S. Population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AABP Integrative Pain Care and Wellness Clinic

Brooklyn, New York, 11204, United States

Location

Study Officials

  • Gary Scott Shwartz, M.D.

    AABP Integrative Pain Care and Wellness Clinic, Brooklyn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 17, 2025

Study Start

January 13, 2025

Primary Completion

February 23, 2025

Study Completion

February 23, 2025

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)