PHIL® Embolic System for Arteriovenous Malformations

Overseen By Cynthia Nguyen

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Alejandro Berenstein

Disqualifiers: Pregnancy, Cancer, Autoimmune, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: Day 1 during procedure

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the PHIL Embolic System safe for use in humans?

The PHIL Embolic System has been used in studies for treating various conditions like cerebral arteriovenous malformations and cranial dural arteriovenous fistulas. These studies have looked at safety by tracking adverse events, and while specific safety outcomes aren't detailed here, the system is being actively researched and used, suggesting a level of safety in clinical settings. ^{1 2 3 4 5}

How is the PHIL Embolic System treatment different from other treatments for arteriovenous malformations?

The PHIL Embolic System is unique because it is a new liquid embolic agent that can be rapidly injected and does not cause skin discoloration, unlike some other treatments. It is also compatible with dimethyl sulfoxide (DMSO), which helps in its administration. ^{1 2 3 6 7}

What is the purpose of this trial?

The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs. The PHIL® Embolic System is a Humanitarian Use Device (HUD). The U.S. Food and Drug Administration (FDA) approved the use of the PHIL Embolic System as a HUD in June 2016.

Research Team

Johanna Fifi, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Alejandro Berenstein, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for children under 22 with intracranial dural arteriovenous fistulas (dAVFs) suitable for embolization using the PHIL® device. They must have consent from a legal representative, be able to follow study procedures, and not weigh less than 2.5kg. Those with severe health risks, allergies to certain substances like DMSO or iodine, pregnant females, or those with life-threatening illnesses other than dAVFs cannot participate.

Inclusion Criteria

Subject and legally authorized representative are willing and capable of complying with all study protocol requirements, including specified follow-up period

I am under 22 years old.

I have a brain vessel malformation suitable for a specific treatment or have been treated before for it.

Exclusion Criteria

I have a bleeding disorder, my INR is over 1.5, or I refuse blood transfusions.

I am at risk for kidney damage from contrast dye or a rare skin condition.

I have a tumor in my brain or am receiving radiation for cancer in my head or neck.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PHIL® Embolic System for the treatment of intracranial dural arteriovenous fistulas

Day 1 during procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of neurological outcomes and angiographic cure

12 months

Multiple visits (in-person and virtual) over 12 months

Treatment Details

Interventions

• PHIL® Embolic System

Trial Overview The PHIL® Embolic System is being tested for safety and potential benefits in treating intracranial dural arteriovenous fistulas in pediatric patients. This system has been approved by the FDA as a Humanitarian Use Device and this study aims to gather more data on its effectiveness.

Participant Groups

Group I: PHIL® device Experimental Treatment 1 Intervention

Using device

PHIL® Embolic System is already approved in United States for the following indications:

Approved in United States as PHIL Embolic System for:

• Intracranial dural arteriovenous fistulas

Who Is Running the Clinical Trial?

Alejandro Berenstein

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

In a study involving five patients with cerebral arteriovenous malformations (AVMs), the new embolic material Precipitating Hydrophobic Injectable Liquid (PHIL) was used successfully, with two patients achieving complete cure of their AVMs.

There were no procedural complications reported during the treatment, indicating that PHIL is a safe option for embolization, although one patient experienced a seizure post-procedure without any signs of hemorrhage on a CT scan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary experience with Precipitating Hydrophobic Injectable Liquid (PHIL) in treating cerebral AVMs. Samaniego, EA., Kalousek, V., Abdo, G., et al.[2019]

In a study of 26 patients with cranial dural arteriovenous fistulas, the new liquid embolic agent PHIL achieved a high rate of complete occlusion (77%) and demonstrated safety with only one adverse event reported.

PHIL's effectiveness and short-term results are comparable to the established agent Onyx, but it offers advantages such as easier preparation and better visualization on imaging, making it a promising option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embolization of Intracranial Dural Arteriovenous Fistulas Using PHIL Liquid Embolic Agent in 26 Patients: A Multicenter Study. Lamin, S., Chew, HS., Chavda, S., et al.[2022]

Precipitating hydrophobic injectable liquid (PHIL) is a new embolic agent that is compatible with dimethyl sulfoxide (DMSO) and offers unique advantages for interventional radiology, including rapid injection and no skin discoloration.

PHIL has been effectively used in various procedures such as trauma embolization, pseudoaneurysm embolization, and tumor embolization, making it a valuable addition to the tools available for body interventional radiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing PHIL (precipitating hydrophobic injectable liquid) - a new embolic agent for the body interventional radiologist. Prashar, A., Butt, S., Shaida, N.[2020]

In a study involving 24 embolization procedures in pigs, the new low-viscosity liquid embolic agent PHIL 25% demonstrated effective distal penetration and adequate visibility, making it a promising option for endovascular embolization.

PHIL 25% low viscosity and another agent, Squid 12, showed significantly lower reflux compared to standard PHIL 25%, indicating better control during the embolization process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of a New Version of the Liquid Embolic Agent PHIL with Extra-Low-Viscosity in an Endovascular Embolization Model. Vollherbst, DF., Otto, R., Hantz, M., et al.[2020]

In a study involving 27 patients with cerebral arteriovenous malformations, the new liquid embolic agent, precipitating hydrophobic injectable liquid, achieved total obliteration in 52% of cases during a single treatment session, indicating promising efficacy.

The treatment was associated with a 22.2% complication rate but no recorded mortality, suggesting that while the agent is generally safe, further research is necessary to fully establish its safety and effectiveness compared to other embolic agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with precipitating hydrophobic injectable liquid in cerebral arteriovenous malformations. Sirakov, SS., Sirakov, A., Minkin, K., et al.[2020]

The use of precipitating hydrophobic injectable liquid (PHIL) as a new liquid embolic agent in a 60-year-old male with a large arteriovenous malformation (AVM) demonstrated excellent penetration into small blood vessels during endovascular embolization, which is crucial for effective treatment.

PHIL showed advantages over existing embolic agents, including reduced glare on imaging and less skin pigmentation, making it a promising alternative for pre-operative embolization of large AVMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel use of precipitating hydrophobic injectable liquid (PHIL) in pre-operative angioembolisation of a large posterior auricular arteriovenous malformation. Chu, C., Tan, THL., Ng, KS., et al.[2023]

In a preliminary study involving eight patients with cranial and spinal dural arteriovenous fistulas (DAVFs), the new liquid embolic agent PHIL successfully achieved complete angiographic exclusion in seven cases, demonstrating its potential efficacy as a treatment option.

No significant complications or neurological deterioration were reported, suggesting that PHIL may be a safe alternative to existing liquid embolic agents, although further research is needed to confirm its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary experience with the liquid embolic material agent PHIL (Precipitating Hydrophobic Injectable Liquid) in treating cranial and spinal dural arteriovenous fistulas: technical note. Leyon, JJ., Chavda, S., Thomas, A., et al.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Preliminary experience with Precipitating Hydrophobic Injectable Liquid (PHIL) in treating cerebral AVMs. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Embolization of Intracranial Dural Arteriovenous Fistulas Using PHIL Liquid Embolic Agent in 26 Patients: A Multicenter Study. [2022]

3. Turkey pubmed.ncbi.nlm.nih.gov

Introducing PHIL (precipitating hydrophobic injectable liquid) - a new embolic agent for the body interventional radiologist. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Investigation of a New Version of the Liquid Embolic Agent PHIL with Extra-Low-Viscosity in an Endovascular Embolization Model. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Initial experience with precipitating hydrophobic injectable liquid in cerebral arteriovenous malformations. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Novel use of precipitating hydrophobic injectable liquid (PHIL) in pre-operative angioembolisation of a large posterior auricular arteriovenous malformation. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Preliminary experience with the liquid embolic material agent PHIL (Precipitating Hydrophobic Injectable Liquid) in treating cranial and spinal dural arteriovenous fistulas: technical note. [2017]