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New treatment option for Vein of Galen Malformations
Official title A Phase II Trial of Fetal Embolization for Vein of Galen Malformation
ClinicalTrials.gov ID: NCT07483255
What this study is testing
- What it's testing
- This is a prospective, single-arm non-randomized interventional study of fetuses to assess the efficacy and safety of fetal embolization of VOGM. Subjects will receive a one-time study intervention of fetal embolization, at or after 34 weeks of gestation.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Pregnant woman carrying a fetus harboring a vein of Galen malformation in whom the straight sinus or falcine sinus draining the prosencephalic varix...
- Fetal gestational age of 34 weeks or more at the time of the planned fetal intervention, as determined by clinical information and evaluation of...
- Anatomic diagnosis of fetal vein of Galen malformation. Various cerebrovascular conditions, such as dural sinus malformation and pial arteriovenous...
You likely can't join if
- Extensive fetal brain parenchymal injury/gliosis, i.e. \>10% of supratentorial brain volume (SFP presentation). In some cases, significant...
- Irreversible fetal non-brain organ injury (e.g. hydrops fetalis as a manifestation of heart failure, a finding which portends fatal outcome in...
- Fetus with VOGM in whom the straight sinus or falcine sinus draining the prosencephalic varix measures less than 7 mm on fetal MRI (T2-weighted...
- Severe maternal obesity pre-pregnancy as defined by body mass index (BMI) of 40 or greater
- Fetuses with major extracranial congenital anomalies
- Evidence of preterm labor, rupture of membranes or abruption
See the full eligibility criteria
- Pregnant woman carrying a fetus harboring a vein of Galen malformation in whom the straight sinus or falcine sinus draining the prosencephalic varix measures 7 mm or more on fetal MRI (medio-lateral diameter measured at...
- Fetal gestational age of 34 weeks or more at the time of the planned fetal intervention, as determined by clinical information and evaluation of first ultrasound. The suitability for fetal treatment, in terms of...
- Anatomic diagnosis of fetal vein of Galen malformation. Various cerebrovascular conditions, such as dural sinus malformation and pial arteriovenous fistula, can result in dilated intracranial vascular structures being...
- Extensive fetal brain parenchymal injury/gliosis, i.e. \>10% of supratentorial brain volume (SFP presentation). In some cases, significant bihemispheric cerebral parenchymal injuries are seen at the time of initial...
- Irreversible fetal non-brain organ injury (e.g. hydrops fetalis as a manifestation of heart failure, a finding which portends fatal outcome in fetuses with vein of Galen malformation).
- Fetus with VOGM in whom the straight sinus or falcine sinus draining the prosencephalic varix measures less than 7 mm on fetal MRI (T2-weighted coronal or axial slice, medio-lateral diameter measured at the narrowest...
- Severe maternal obesity pre-pregnancy as defined by body mass index (BMI) of 40 or greater
- Fetuses with major extracranial congenital anomalies
- Evidence of preterm labor, rupture of membranes or abruption
- Maternal coagulopathy: INR \> 1.2; PT/PTT above normal ranges for the lab; platelets \<100
- Any maternal use of anticoagulants, whether prophylactic or therapeutic.
- Prior maternal medical history that would preclude epidural anesthesia
- Multi-fetal pregnancy
- Placenta previa or accreta
- Participation in another fetal study that influences maternal and fetal morbidity and mortality
- Known maternal hypersensitivity to 316LM stainless steel
- Supine hypotensive syndrome
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.