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

NCT ID: NCT04040179

Last Updated: 2019-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-05

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Ultrasound Imaging of Anatomical Structures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IntelligentUltrasound Limited

INDUSTRY

Sponsor Role collaborator

Medaphor Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medicentre

Cardiff, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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IU2019_AG_03

Identifier Type: -

Identifier Source: org_study_id

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