EMBA Peripheral Embolization Device ("EPED") Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-08-31

Brief Summary

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

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Detailed Description

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This study is a FIM, open label, prospective, single center, non-randomized, evaluation of the EMBA Medical Peripheral Embolization Device (PED) used for arterial or venous embolization in the peripheral vasculature.

Conditions

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Peripheral Embolization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm - EMBA PED

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

Group Type OTHER

The EMBA Peripheral Embolization Device

Intervention Type DEVICE

arterial and venous embolization in the peripheral vasculature

Interventions

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The EMBA Peripheral Embolization Device

arterial and venous embolization in the peripheral vasculature

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The patient is \>18 years of age.
2. Patient is considered a candidate for arterial or venous embolization in the peripheral vasculature.
3. 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.
4. 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.
5. The patient has suitable vessel anatomy that would allow proper placement of the PED.

Exclusion Criteria

1. The patient has one of the following conditions:

1.1 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
2. The patient has an uncontrolled infectious disease.
3. The patient has a life expectancy of less than 6 months.
4. The patient is pregnant.
5. The patient has a condition that inhibits radiographic visualization of the PED.
6. The patient has a known allergy or intolerance to Nitinol.
7. The patient has a known hypersensitivity to contrast that cannot be pre-treated.
8. The patient's access vessels preclude safe insertion of the delivery system.
9. The patient is currently participating in another device or drug study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No