Fetal Embolization for Vein of Galen Malformation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a one-time procedure to treat fetuses with abnormal brain blood vessels using tiny coils. It aims to help fetuses with Vein of Galen Malformation, a condition that can cause serious health problems. The coils block the abnormal vessels to prevent complications.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulation medication, you may not be eligible to participate.
Is fetal embolization for vein of Galen malformation safe?
Recent studies show that improvements in embolization techniques have led to better outcomes, with no mortality in a recent series of 11 patients and most patients being functionally normal at follow-up. However, there is still a risk of severe neurological deficits and developmental delays in some cases.12345
How does the treatment with Target XL and XXL Detachable Coils differ from other treatments for vein of Galen malformation?
The treatment using Target XL and XXL Detachable Coils is unique because it involves a minimally invasive procedure called embolization, where coils are used to block abnormal blood flow in the vein of Galen. This approach is less invasive compared to traditional surgery and has shown improved outcomes in neonates with this condition, reducing mortality and severe complications.25678
What data supports the effectiveness of this treatment for vein of Galen malformation?
Who Is on the Research Team?
Darren Orbach, MD PhD
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
This trial is for pregnant women with a fetus diagnosed with Vein of Galen Malformation (VOGM), where the affected sinus measures at least 8 mm. The mother must be over 18, able to travel for study visits, and have a well-preserved fetal brain structure. Exclusions include preterm labor risks, maternal coagulopathy or diseases requiring anticoagulation, prior conditions preventing epidural anesthesia, multiple pregnancies, placenta issues, other conflicting studies participation, metal hypersensitivity and severe obesity.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Fetal Intervention
A one-time fetal embolization procedure is performed using maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization.
Prenatal Follow-up
Data is collected every 4 weeks post-procedure until delivery to monitor safety and efficacy.
Postnatal Follow-up
Neurological assessments are performed every 6 months for 2 years after delivery to monitor long-term outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- Target XL and XXL Detachable Coils
Find a Clinic Near You
Who Is Running the Clinical Trial?
Darren Orbach
Lead Sponsor