NCT02335788

Completed

EMBA Peripheral Embolization Device ("EPED") Study

EMBA Medical, Inc.Source

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Other study identifiers

Sponsor study identifier

PRT-EPE-0028

Study Type

interventional

Actual enrollment (reported)

15

Locations

1 country

Sites

1

Timeline

Study Start

February 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2016

Actual (reported)

Study Completion

August 2016

Actual (reported)

Brief Summary

This is an open label, acute, non-randomized, prospective, "first in man" (FIM) single-center study of the EMBA Medical Peripheral Embolization Device (PED).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 15 participants
Study completion date: August 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
January 6, 2015
Actual (reported)
First Posted
January 12, 2015
Actual (reported)
Study Start
February 2015
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
August 2016
Actual (reported)
Study Completion
August 2016
Actual (reported)

Last Updated: July 28, 2022
Status Verified: July 2022
Last Update Submitted: July 26, 2022

Conditions

Peripheral Embolization

Keywords

TherapeuticEmbolization

Outcome Measures

Primary Outcomes (1)

Target vessel occlusion (assessed by CTA)
vessel occlusion as assessed by CTA
30 Days

Study Arms (1)

Single arm - EMBA PED

OTHER

The EMBA Peripheral Embolization Device when indicated for arterial and venous embolization in the peripheral vasculature.

Device: The EMBA Peripheral Embolization Device

Interventions

The EMBA Peripheral Embolization DeviceDevice

arterial and venous embolization in the peripheral vasculature

Single arm - EMBA PED

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The patient is \>18 years of age.
Patient is considered a candidate for arterial or venous embolization in the peripheral vasculature.

Sponsors & Collaborators

EMBA Medical, Inc.
Industrylead

Study Sites (1)

Auckland City Hospital

Grafton, Auckland, 1023, New Zealand

Study Officials

Andrew Holden, MD
Auckland City Hospital
PRINCIPAL INVESTIGATOR

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 12, 2015

Study Start

February 2015

Date type not reported

This date has not been verified as actual or estimated.

Patient has a target vessel diameter of 3-8mm and a target PED landing zone of greater than 25mm wherein the vessel diameter is between 3 and 8 mm.

The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.

The patient has suitable vessel anatomy that would allow proper placement of the PED.

You may not qualify if:

The patient has one of the following conditions:
Arterio-venous fistula 1.2 Hypercoagulability 1.3 Systemic coagulopathy 1.4 Connective tissue disorder such as Ehlers-Danlos Syndrome 1.5 Congenital arteritis such as Takayasu's Disease 1.6 Other circulatory disorders at the discretion of the implanting physician
The patient has an uncontrolled infectious disease.
The patient has a life expectancy of less than 6 months.
The patient is pregnant.
The patient has a condition that inhibits radiographic visualization of the PED.
The patient has a known allergy or intolerance to Nitinol.
The patient has a known hypersensitivity to contrast that cannot be pre-treated.
The patient's access vessels preclude safe insertion of the delivery system.
The patient is currently participating in another device or drug study.

Contact the study team to confirm eligibility.

Primary Completion

August 2016

Actual (reported)

Study Completion

August 2016

Actual (reported)

Last Updated

July 28, 2022

Record last verified: 2022-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02335788
Data provider: ClinicalTrials.gov
Source updated: 2022-07-28
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:17:59 UTC

Locations

NZ(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Single arm - EMBA PED

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations