A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide

This is a single-centre, prospective, non-randomised volunteer study to be undertaken in the MediCentre, Heath Park, Cardiff, UK

Study Overview

• Status: Completed
• Conditions: Ultrasound Imaging of Anatomical Structures

Detailed Description

This is a single-centre, non-randomised, prospective study involving at least 120 participants. The data collected in this study will augment the data collected in IU2019_AG_03 Volunteers will be enrolled sequentially until at least 120 scans have been recorded. Ideally, between 120 and 150 scans will be recorded.

Phase I Data collected from up to the first 80 participants in each of the six peripheral nerve block areas will be used as a training/verification set. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images.

Phase II The remaining 40 videos in each area (total minimum 120 participants) will be used for validation of these models.

The validation videos will be fed into the models created during Phase I of the study and the output anatomy highlighting will be recorded as a separate video, overlaid on the original ultrasound image. The overlay video will then be further split into 30-second segments.

A panel of three independent expert anaesthetists will be convened to review and score the segments for accuracy and performance to the endpoints agreed in Phase I of the study.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United Kingdom
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4UJ
      • MediCentre, Heath Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers who respond to adverts placed at the University Hospital of Wales (UHW) and related sites in Cardiff.

Description

Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged <18 years of age;
2. Unwilling or unable to provide informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Model development and verification	Collection of ultrasound scans. The collected scans will be assessed and used in the development and verification of deep-learning models that identify the target structures using a training dataset.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Model validation	Estimation of performance and accuracy (e.g. success/failure of highlighting of target structures, average distance of highlighting from target, time spent highlighting correct structure as a proportion of time target visible)	4 months

Collaborators and Investigators

• Sponsor: IntelligentUltrasound Limited
• Investigators: Study Director: Steve Margetts, IntelligentUltrasound Limited

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IU2020_AG_04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No