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

Intelligent Ultrasound

Status: Completed

Conditions: Ultrasound Imaging of Anatomical Structures

Study type: Observational

Funder types: Industry

Identifiers

NCT04277169

IU2020_AG_04

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.