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A Study to Evaluate the Performance and Potential Benefits of an Assistive Artificial Intelligence Device ScanNav Anatomy Peripheral Nerve Block - US V1.0 for Ultrasound-guided Regional Anesthesia

NCT04918693 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2022-04-01

No results posted yet for this study

Summary

This is a single-center, prospective study to be undertaken at University of Oregon, Portland, USA. The aim is to provide data on the clinical performance of ScanNav Anatomy PNB for identification of anatomical structures during UGRA scanning, in particular:

1. Assess the benefits of the device to intended users when supervising a trainee who is performing UGRA scanning.
2. Assess the benefits of the device when intended users perform UGRA scanning.
3. Assess risk mitigation by the intended users when performing UGRA scanning.

Conditions

  • Ultrasound Imaging of Anatomical Structures

Interventions

DEVICE

Ultrasound scanning

All participants will scan with and without device and trainee on 4 models. The order of the device assistance and models will be randomized between participants, but participant will always have exposure to device first before supervising the trainee.

Sponsors & Collaborators

  • IntelligentUltrasound Limited

    lead INDUSTRY

Principal Investigators

  • Glenn Woodworth, MD · Oregon Health and Science University

  • James Bowness, MD · University of Oxford & Royal Gwent Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-16
Primary Completion
2021-05-22
Completion
2021-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04918693 on ClinicalTrials.gov