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

Ultrasound Imaging of Anatomical Structures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040179
• Other study ID #: IU2019_AG_03
• Status: Completed
• Start date: August 5, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2019
• Source: Medaphor Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ultrasound Imaging of Anatomical Structures

Locations

Country	Name	City	State
United Kingdom	Medicentre	Cardiff

Sponsors (2)

Lead Sponsor	Collaborator
Medaphor Limited	IntelligentUltrasound Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

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