EMBA Peripheral Embolization Device ("EPED") Study

• Sponsor: EMBA Medical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02335788
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 18
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Embolization	Device: The EMBA Peripheral Embolization Device	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: EMBA Peripheral Embolization Device ("EPED") Study
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Single arm - EMBA PED The EMBA Peripheral Embolization Device when indicated for arterial and venous embolization in the peripheral vasculature.	Device: The EMBA Peripheral Embolization Device; arterial and venous embolization in the peripheral vasculature

Outcome Measures

Primary Outcome Measures

1. Target vessel occlusion (assessed by CTA) [30 Days]

   vessel occlusion as assessed by CTA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. The patient has an uncontrolled infectious disease.

2. The patient has a life expectancy of less than 6 months.

3. The patient is pregnant.

4. The patient has a condition that inhibits radiographic visualization of the PED.

5. The patient has a known allergy or intolerance to Nitinol.

6. The patient has a known hypersensitivity to contrast that cannot be pre-treated.

7. The patient's access vessels preclude safe insertion of the delivery system.

8. The patient is currently participating in another device or drug study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Auckland City Hospital	Grafton	Auckland	New Zealand	1023

Sponsors and Collaborators

• EMBA Medical, Inc.

Investigators

• Principal Investigator: Andrew Holden, MD, Auckland City Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EMBA Medical, Inc.
• ClinicalTrials.gov Identifier: NCT02335788
• Other Study ID Numbers: PRT-EPE-0028
• First Posted: Jan 12, 2015
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by EMBA Medical, Inc.: Therapeutic; Embolization

Study Results

No Results Posted as of Jul 28, 2022