Robustness Check of Placement and Measurement Algorithms... | NCT05193760

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

NCT05193760

Sponsor

Catharina Ziekenhuis Eindhoven

Status

Completed

Last Update Posted

Feb 14, 2023Actual

Enrollment

67Actual

Phase

Not provided

Conditions

Coronary Artery Disease
Aortic Valve Disease
Mitral Valve Disease

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
nWMO-2021.081	Other Identifier	MEC-U

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 6, 2021Actual

Primary Completion Date

Sep 28, 2022Actual

Completion Date

Sep 28, 2022Actual

First Submitted Date

Dec 23, 2021

First Submission Date that Met QC Criteria

Jan 14, 2022

First Posted Date

Jan 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2023

Last Update Posted Date

Feb 14, 2023Actual

Name	Class
Philips Electronics Nederland BV	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study has four objectives:

Determine the robustness of the placement and measurement algorithms with ultrasound images, obtained with different ultrasound system settings and probe movements.
Verificate and optimize the arterial blood flow model.
Determine the variation in location and size of the arteries and veins in the area around the common carotid artery.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Robustness of placement and measurement algorithms.	Using the obtained US images of the common carotid artery, the robustness of our algorithms for placement and measurements will be checked.	During data acquisition, which is pre-surgery.
Verify and improve the arterial blood flow model.	Using the obtained US images of the common carotid artery, our arterial blood flow model will be verified and adapted.	During data acquisition, which is pre-surgery.
Orientation of ultrasound probe.	Using the obtained US images of the common carotid artery, the influence of probe orientation on carotid artery parameters will be investigated.	During data acquisition, which is pre-surgery.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult (>18 years) cardiac surgery or TAVI patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catharina Ziekenhuis Eindhoven		Eindhoven	North Brabant	5652 EJ	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D000082862	Aortic Valve Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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