NCT04277169

Brief Summary

This is a single-centre, prospective, non-randomised volunteer study to be undertaken in the MediCentre, Heath Park, Cardiff, UK

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

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

January 23, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

January 23, 2020

Last Update Submit

February 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Model development and verification

    Collection of ultrasound scans. The collected scans will be assessed and used in the development and verification of deep-learning models that identify the target structures using a training dataset.

    4 months

Secondary Outcomes (1)

  • Model validation

    4 months

Eligibility Criteria

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

Healthy volunteers who respond to adverts placed at the University Hospital of Wales (UHW) and related sites in Cardiff.

You may qualify if:

  • Male or female, at least 18 years of age;
  • 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, Heath Park

Cardiff, Wales, CF14 4UJ, United Kingdom

Location

Study Officials

  • Steve Margetts

    IntelligentUltrasound Limited

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 23, 2020

First Posted

February 20, 2020

Study Start

February 1, 2020

Primary Completion

May 31, 2020

Study Completion

September 1, 2020

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations