EMBA Peripheral Embolization Device ("EPED") Study (EPED)

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

Study Overview

• Status: Completed
• Conditions: Peripheral Embolization
• Intervention / Treatment: Device: The EMBA Peripheral Embolization Device

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland
    • Grafton, Auckland, New Zealand, 1023
      • Auckland City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel occlusion (assessed by CTA)	vessel occlusion as assessed by CTA	30 Days

Collaborators and Investigators

• Sponsor: EMBA Medical, Inc.
• Investigators: Principal Investigator: Andrew Holden, MD, Auckland City Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: January 6, 2015
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 12, 2015

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Therapeutic; Embolization
• Other Study ID Numbers: PRT-EPE-0028