An interventional study of PHIL® Liquid Embolic System in Arteriovenous Dural Fistula, sponsored by Microvention-Terumo, Inc.. Completed at 1 site in United States. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-31.
Sponsored by Microvention-Terumo, Inc. (part of Terumo Corporation) · Not applicable, Interventional, and Treatment
This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.
219 studies on the registry are indexed under Fistula; 49 are open to participants now.
This study's enrollment of 64 is above the median of 50 across 152 interventional studies indexed under Fistula.
Browse Fistula studies →Microvention-Terumo, Inc. is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
First submitted after Microvention-Terumo, Inc. became part of Terumo Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PHIL® Liquid Embolic System
Device: PHIL® Liquid Embolic System
The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Subjects With Neurological Death or Ipsilateral Stroke
Reported incidences of death or ipsilateral stroke
Time frame: 30 days
Technical Events During the PHIL Embolization Procedure(s)
Reported incidences of technical events with PHIL device
Time frame: During the procedure
Device-related Adverse Events
Time frame: 30 days
| Milestone | dAVF Treatment |
|---|---|
| Started | 62 |
| Completed | 60 |
| Not completed | 2 |
Reported incidences of death or ipsilateral stroke
| Participants | dAVF Treatment |
|---|---|
| Subjects With Neurological Death or Ipsilateral Stroke | 0 |
Reported incidences of technical events with PHIL device
| Participants | dAVF Treatment |
|---|---|
| Technical Events During the PHIL Embolization Procedure(s) | 0 |
| Participants | dAVF Treatment |
|---|---|
| Device-related Adverse Events | 1 |
Collected over 6 months after last embolization. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| dAVF Treatment | 1/62 (1.6%) | 5/62 (8.1%) | 27/62 (43.5%) |
| Event | dAVF Treatment |
|---|---|
| Acute myocardial infarctionCardiac disorders | 1/62 |
| Upper respiratory tract infectionInfections and infestations | 1/62 |
| Head injuryInjury, poisoning and procedural complications | 1/62 |
| Failure to thriveMetabolism and nutrition disorders | 1/62 |
| SeizureNervous system disorders | 1/62 |
| Acute kidney injuryRenal and urinary disorders | 1/62 |
| Aortic dissectionVascular disorders | 1/62 |
| Event | dAVF Treatment |
|---|---|
| HeadacheNervous system disorders | 6/62 |
| Radiation alopeciaInjury, poisoning and procedural complications | 4/62 |
| Procedural headacheNervous system disorders | 3/62 |
| Procedural nauseaInjury, poisoning and procedural complications | 2/62 |
| SeizureNervous system disorders | 2/62 |
| dysacusisEar and labyrinth disorders | 1/62 |
| TinnitusEar and labyrinth disorders | 1/62 |
| DiplopiaEye disorders | 1/62 |
| Visual acuity reducedEye disorders | 1/62 |
| Visual impairmentEye disorders | 1/62 |
| Age, Customized(years) | dAVF Treatment |
|---|---|
| Age | 56.6 ± 13.31 |
| Sex: Female, Male(Participants) | dAVF Treatment |
|---|---|
| Female | 19 |
| Male | 43 |
| Ethnicity (NIH/OMB)(Participants) | dAVF Treatment |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 53 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | dAVF Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 45 |
| More than one race | 0 |
| Unknown or Not Reported | 7 |
| Region of Enrollment(participants) | dAVF Treatment |
|---|---|
| United States | 62 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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