Collect Flow and Ultrasound Images of Coronary Bypass Grafts | NCT06360224

Studies
Collect Flow and Ultrasound Images of Coronary Bypass Grafts

NCT06360224

Sponsor

Medistim ASA

Status

Not yet recruiting

Last Update Posted

Apr 11, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cardiac Bypass Surgery (CABG)

Interventions

MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes

Countries

Not provided

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

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2024Estimated

Primary Completion Date

May 15, 2029Estimated

Completion Date

May 15, 2029Estimated

First Submitted Date

Apr 6, 2024

First Submission Date that Met QC Criteria

Apr 6, 2024

First Posted Date

Apr 11, 2024Actual

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

Apr 6, 2024

Last Update Posted Date

Apr 11, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes	Device	The objective of this study is to harvest a wide dataset of high quality to allow exploratory analysis and training of machine learning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wide and high-quality dataset uploaded to CaseCloud from CABG-procedures.		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient older than 18 years
Scheduled for CABG
Understand the nature of the procedure and willingness to comply with the CIP
Provide written informed consent

Exclusion Criteria:

Patient younger than 18 years
Any condition that the investigator believes should exclude participation

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

Patients scheduled for cardiac bypass surgery (CABG) that have signed an informed consent form for this study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haakon Grøthe	Contact	04790968263		haakon.groethe@medistim.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided