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OpenTrials
Completed

NCT Number: NCT03654300

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medicentre

Cardiff, CF14 4UJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, at least 18 years of age;
  • Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories:
  • Adductor canal
  • Popliteal fossa
  • Fascia Iliaca
  • Rectus sheath
  • Axillary region
  • Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion criteria

  • Aged <18 years of age;
  • Unwilling or unable to provide informed consent.

Treatment and study plan

Primary outcomes

  1. Model development

    Time frame: 6 months

    models with a Mean intersection over Union score of 0.95 or better for each region in each category.

Sponsors and collaborators

Lead sponsor

Medaphor Limited

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2018
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.