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

NCT ID: NCT04277169

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2020-09-01

Brief Summary

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

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.

Conditions

Ultrasound Imaging of Anatomical Structures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IntelligentUltrasound Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Margetts

Role: STUDY_DIRECTOR

IntelligentUltrasound Limited

Locations

MediCentre, Heath Park

Cardiff, Wales, United Kingdom

Countries

United Kingdom

Other Identifiers

IU2020_AG_04

Identifier Type: -

Identifier Source: org_study_id