Peripheral EmbolizationEPEDNCT02335788
EMBA Peripheral Embolization Device ("EPED") Study
A study testing The EMBA Peripheral Embolization Device in people with Peripheral Embolization, run by EMBA Medical, Inc. at 1 site in New Zealand.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Embolization
- What is being tested?
- The EMBA Peripheral Embolization Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNew Zealand
- Study dates
- Feb 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is >18 years of age.
- Patient is considered a candidate for arterial or venous embolization in the peripheral vasculature.
- 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.
- 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.
- The patient has suitable vessel anatomy that would allow proper placement of the PED.
Who cannot join
- 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
- The patient has an uncontrolled infectious disease.
- The patient has a life expectancy of less than 6 months.
- The patient is pregnant.
- The patient has a condition that inhibits radiographic visualization of the PED.
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- The patient has a known allergy or intolerance to Nitinol.
- The patient has a known hypersensitivity to contrast that cannot be pre-treated.
- The patient's access vessels preclude safe insertion of the delivery system.
- The patient is currently participating in another device or drug study.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open label, acute, non-randomized, prospective, "first in man" (FIM) single-center study of the EMBA Medical Peripheral Embolization Device (PED).
Read the 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.
- Conditions
- Peripheral Embolization
- Being tested
- The EMBA Peripheral Embolization Device
- Keywords
- Therapeutic, Embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The EMBA Peripheral Embolization DeviceDevice
arterial and venous embolization in the peripheral vasculature
| Study group | Role | What they receive |
|---|---|---|
| Single arm - EMBA PED | Other | The EMBA Peripheral Embolization Device when indicated for arterial and venous embolization in the peripheral vasculature. Receives: Device: The EMBA Peripheral Embolization Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel occlusion (assessed by CTA)
vessel occlusion as assessed by CTA
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral EmbolizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMBA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, MD, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335788
- Sponsor's protocol ID
- PRT-EPE-0028
- Acronym
- EPED
- Status last verified
- Jul 2022
- First submitted
- 6 Jan 2015
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMBA Peripheral Embolization Device ("EPED") Study
- ClinicalTrials.gov ID
- NCT02335788
- Acronym / sponsor ID
- EPED / PRT-EPE-0028
- Conditions
- Peripheral Embolization
- Keywords
- Therapeutic, Embolization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- EMBA Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm - EMBA PED | Other | Device: The EMBA Peripheral Embolization DeviceThe EMBA Peripheral Embolization Device when indicated for arterial and venous embolization in the peripheral vasculature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is >18 years of age.
- Patient is considered a candidate for arterial or venous embolization in the peripheral vasculature.
- 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.
- 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.
- The patient has suitable vessel anatomy that would allow proper placement of the PED.
Key exclusion criteria (10 listed)
- 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
- The patient has an uncontrolled infectious disease.
- The patient has a life expectancy of less than 6 months.
- The patient is pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The EMBA Peripheral Embolization Devicearterial and venous embolization in the peripheral vasculature | Device | Single arm - EMBA PED |
Primary outcome
Target vessel occlusion (assessed by CTA)
Time frame: 30 Days
vessel occlusion as assessed by CTA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Holden, MD principal investigator
Auckland City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The EMBA Peripheral Embolization Device in people with Peripheral Embolization, run by EMBA Medical, Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel occlusion (assessed by CTA) (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.