Clincosm LogoSign in Get a demo

RAdiUS: Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery

Sponsor
Catharina Ziekenhuis Eindhoven (Other)
Overall Status
Recruiting
CT.gov ID
NCT05193760
Collaborator
Philips Electronics Nederland BV (Industry)
75
Enrollment
1
Location
7.8
Anticipated Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is set up to test the robustness of algorithms and models and to optimize them. Furthermore, data are used to investigate the influence of probe orientation on parameters of the common carotid artery.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study has four objectives:

    1. Determine the robustness of the placement and measurement algorithms with ultrasound images, obtained with different ultrasound system settings and probe movements.

    2. Verificate and optimize the arterial blood flow model.

    3. Determine the variation in location and size of the arteries and veins in the area around the common carotid artery.

    4. Determine the influence of probe orientation on parameters obtained from ultrasound measurements of the common carotid artery.

    Sample size and missing data Due to limited time in the operating room, the measurement protocol is divided into four parts. Per protocol part data of 25 patients is deemed sufficient to be able to answer the above-mentioned objectives, which would result in a total of 100 inclusions. However, the investigators expect to perform more than one measurement protocol per patient, due to which a total of 75 inclusions is needed. Patients of whom the data is qualitatively too low to be used for analysis will be replaced. As such, the investigators make sure to have qualitatively good data of 25 patients per protocol part.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
    Actual Study Start Date :
    Oct 6, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Robustness of placement and measurement algorithms. [During data acquisition, which is pre-surgery.]

      Using the obtained US images of the common carotid artery, the robustness of our algorithms for placement and measurements will be checked.

    2. Verify and improve the arterial blood flow model. [During data acquisition, which is pre-surgery.]

      Using the obtained US images of the common carotid artery, our arterial blood flow model will be verified and adapted.

    3. Orientation of ultrasound probe. [During data acquisition, which is pre-surgery.]

      Using the obtained US images of the common carotid artery, the influence of probe orientation on carotid artery parameters will be investigated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult (>18 years) patients.

    • Participant should be able to provide informed consent in Dutch.

    Exclusion Criteria:

    • Participant has a known stenosis of the carotid artery.

    • Patient has open wounds in the measurement area (area in the neck around the carotid artery).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Catharina Ziekenhuis Eindhoven Eindhoven Noord-Brabant Netherlands 5652 EJ

    Sponsors and Collaborators

    • Catharina Ziekenhuis Eindhoven
    • Philips Electronics Nederland BV

    Investigators

    • Principal Investigator: Arthur Bouwman, MD PhD, Catharina Ziekenhuis Eindhoven
    • Study Chair: John van Rooij, MSc, Philips Electronics Nederland B.V.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Esmée de Boer, Doctoral Candidate, Catharina Ziekenhuis Eindhoven
    ClinicalTrials.gov Identifier:
    NCT05193760
    Other Study ID Numbers:
    • ICBE 2-35542
    • nWMO-2021.081
    First Posted:
    Jan 18, 2022
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Esmée de Boer, Doctoral Candidate, Catharina Ziekenhuis Eindhoven
    Common carotid artery
    Ultrasound
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Aortic Valve Disease

    Study Results

    No Results Posted as of Jan 18, 2022