NCT04040179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

August 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 10, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

July 30, 2019

Last Update Submit

October 9, 2019

Conditions

Ultrasound Imaging of Anatomical Structures

Outcome Measures

Primary Outcomes (1)

  • Model development

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

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

  • 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
  • ESP
  • PECS
  • Interscalene
  • Able to comprehend and sign the Informed Consent prior to enrolment in the study.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicentre

Cardiff, CF14 4UJ, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

July 31, 2019

Study Start

August 5, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 10, 2019

Record last verified: 2019-07

Locations

GB(1)