Micro Plug Set - Post Market Clinical Follow-up (PMCF) Plan | NCT04218292

Studies
Micro Plug Set - Post Market Clinical Follow-up (PMCF) Plan

NCT04218292

Sponsor

KA Medical, LLC

Status

Unknown status

Last Update Posted

Apr 23, 2021Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Trauma Injury
Bleeding

Interventions

Micro Plug Set

Countries

Germany

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KAM-P4-21-01	Other Identifier	Merit Medical Systems, Inc.

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2020Actual

Primary Completion Date

Feb 28, 2022Estimated

Completion Date

Feb 28, 2022Estimated

First Submitted Date

Jan 2, 2020

First Submission Date that Met QC Criteria

Jan 2, 2020

First Posted Date

Jan 6, 2020Actual

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 21, 2021

Last Update Posted Date

Apr 23, 2021Actual

Name	Class
Merit Medical Systems, Inc.	INDUSTRY

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.

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

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Micro Plug Set	Device	The Micro Plug Set is indicated for arterial embolization in the peripheral vasculature.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of serious device-related and procedure-related adverse events	Rate of serious device-related and procedure-related adverse events	12 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of successful delivery of the device	Rate of successful delivery of the Micro Plug device to the intended position.	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is scheduled for arterial embolization in the peripheral vasculature.
Subject is greater than 18 years of age

Exclusion Criteria:

Subject is unable to give informed consent
Subject is pregnant or breastfeeding
Subject has allergy to nickel
Patient requires neurologic or cardiac use of an occlusion device, contrary to the Micro Plug Set Instructions For Use.

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 requiring routine standard of care for peripheral embolization. Some of the patients will be liver cancer patients undergoing palliative treatment with SIRT who have a life expectancy that may be less than 12 months. Other patients may be treated for trauma or bleeding.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maciej Pech, MD	University Hospital Magdeburg, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Magdeburg		Magdeburg		39120	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Feb 23, 2022
Reset	May 11, 2022

Submission Tracking

Estimated Results First Submitted Date

Feb 23, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 23, 2022			May 11, 2022

Condition Browse Module

MeSH Terms

ID	Term
D000081084	Accidental Injuries
D006470	Hemorrhage

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided