EMBA Peripheral Embolization Device ("EPED") Study

Not Applicable

Completed

• Conditions: Peripheral Embolization
• Interventions: Device: The EMBA Peripheral Embolization Device

• Registration Number: NCT02335788
• Lead Sponsor: EMBA Medical, Inc.

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-12
• Study Start: 2015-02
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm - EMBA PED	The EMBA Peripheral Embolization Device	The EMBA Peripheral Embolization Device when indicated for arterial and venous embolization in the peripheral vasculature.

Primary Outcome Measures

Name	Time	Method
Target vessel occlusion (assessed by CTA)	30 Days	vessel occlusion as assessed by CTA

Trial Locations

Locations (1)

Auckland City Hospital; 🇳🇿 Grafton, Auckland, New Zealand