EMBA Peripheral Embolization Device ("EPED") Study

Peripheral Embolization Clinical Trial

— EPED  

Official title:

EMBA Peripheral Embolization Device ("EPED") Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335788
• Other study ID #: PRT-EPE-0028
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: July 2022
• Source: EMBA Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Embolization

Intervention

Device:
• The EMBA Peripheral Embolization Device
arterial and venous embolization in the peripheral vasculature

Locations

Country	Name	City	State
New Zealand	Auckland City Hospital	Grafton	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
EMBA Medical, Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vessel occlusion (assessed by CTA)	vessel occlusion as assessed by CTA	30 Days