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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasound Imaging of Anatomical Structures

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 region 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.

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF14 4UJ
    • Medicentre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy volunteers, male and female, aged 18 years or more.

Description

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 region
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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medaphor Limited

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2018
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: ML2018_AG_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No