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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04040179

Enrollment

Registered

2019-07-31

Start date

2019-08-05

Completion date

2019-09-30

Last updated

2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound Imaging of Anatomical Structures

Brief summary

The aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia.

Detailed description

The study will involve adult volunteers who are willing to be scanned by a trained sonographer to collect ultrasound video data for the following categories: * Adductor canal * Popliteal fossa * Fascia Iliaca * Rectus sheath * Axillary * ESP * PECS * Interscalene Each volunteer will be scanned to collect data for every category in the list. Where applicable, both sides of the body will be scanned. The videos will be segmented by hand to identify the relevant anatomical regions for each category. The primary objective for this study is to provide the range of data required to develop robust models in conjunction with additional data from patients undergoing a Peripheral Nerve Block procedure that are able to produce the desired segmentation on the unseen validation images. The models will be scored using the standard Mean intersection over Union pixel-level metric for semantic segmentation.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Male or female, at least 18 years of age; 2. Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories: * Adductor canal * Popliteal fossa * Fascia Iliaca * Rectus sheath * Axillary * ESP * PECS * Interscalene 3. 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.

Design outcomes

Primary

Measure	Time frame	Description
Model development	6 months	Models with a Mean intersection over Union score of 0.95 or better for each region in each category.

Countries

United Kingdom

Outcome results