A Study to Collect Imaging Data for the Validation of the Intelligent Ultrasound's ScanNav Anatomy Peripheral Nerve Block (PNB) - US v1.0

NCT04906018 | Completed FDA Device

• 1 other identifier: IU2021_AG_07
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective study to be undertaken at University of Oregon, Portland, USA. The aim is to evaluate the clinical performance of ScanNav Anatomy PNB when highlighting anatomical structures during UGRA scanning. Specifically, we aim to assess and quantify the correct/incorrect highlighting of anatomical structures associated with ScanNav Anatomy PNB during UGRA scanning.

Conditions

Ultrasound Imaging of Anatomical Structures

Outcome Measures

Primary Outcomes (1)

• ScanNav Anatomy PNB highlighting misidentification of structures

  Frequency of misidentification of structures \[% of total, per anatomical region\]

  6 months

Secondary Outcomes (3)

• ScanNav Anatomy PNB highlighting identification of structures

  6 months

• ScanNav Anatomy PNB safety issues

  6 months

• ScanNav Anatomy PNB adverse events

  6 months

Study Arms (2)

volunteer group - BMI less than 30

Each subject with a BMI less than 30 will be randomly allocated to an ultrasound machine and an expert scanner who will perform the ultrasound scans of all supported anatomical regions.

Device: Ultrasound scans

volunteer group - BMI of 30 and above

Each subject with a BMI of 30 and above will be randomly allocated to an ultrasound machine and an expert scanner who will perform the ultrasound scans of all supported anatomical regions.

Device: Ultrasound scans

Interventions

Ultrasound scans DEVICE

Each subject will be randomly allocated to an ultrasound machine and an expert scanner who will perform the ultrasound scans of all supported anatomical regions.

volunteer group - BMI less than 30; volunteer group - BMI of 30 and above

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Potential study subjects will be healthy volunteers, chosen to provide a variety of ages and BMIs. Subjects will be screened to ensure approximate equal numbers in coverage for BMI (\<30, 30-39) category.

You may qualify if:

• Male or female, at least 18 years of age;
• Able to comprehend and sign the Informed Consent prior to enrolment in the study.
• Vaccinated against SARS-CoV-2

You may not qualify if:

• Aged \<18 years of age;
• Unwilling or unable to provide informed consent.
• BMI\> 39 kg/m2
• Known pathology of the area to be scanned

Sponsors & Collaborators

• IntelligentUltrasound Limited: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Bowness JS, Burckett-St Laurent D, Hernandez N, Keane PA, Lobo C, Margetts S, Moka E, Pawa A, Rosenblatt M, Sleep N, Taylor A, Woodworth G, Vasalauskaite A, Noble JA, Higham H. Assistive artificial intelligence for ultrasound image interpretation in regional anaesthesia: an external validation study. Br J Anaesth. 2023 Feb;130(2):217-225. doi: 10.1016/j.bja.2022.06.031. Epub 2022 Aug 18.

  PMID: 35987706 DERIVED

Study Officials

• Glenn Woodworth, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• James Bowness, MD

  University of Oxford & Royal Gwent Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: May 16, 2021
• Primary Completion: May 16, 2021
• Study Completion: November 30, 2021
• Last Updated: April 1, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)