Fetal Embolization for Vein of Galen Malformation

Recruiting in Palo Alto (17 mi)

Overseen byDarren Orbach, MD PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Darren Orbach

No Placebo Group

Trial Summary

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.

Research Team

Darren Orbach, MD PhD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

I am 18 years old or older.

I am pregnant and my fetus has a specific brain vessel malformation diagnosed by MRI.

I am a candidate for continuous lower back pain relief through an epidural.

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Exclusion Criteria

You are showing signs of early labor, water breaking, or separation of the placenta.

Unborn babies with a specific type of brain blood vessel abnormality that measures less than 8 mm on a special type of MRI test will not be included in the study.

Unborn babies with serious birth defects.

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Treatment Details

Interventions

Target XL and XXL Detachable Coils (Vascular Embolization Device)

Trial OverviewThe trial tests fetal embolization using Target XL and XXL Detachable Coils on fetuses with VOGM to evaluate safety and effectiveness. It's a single-arm study comparing results against historical data. Participants undergo one-time embolization followed by regular check-ups until delivery and neurological assessments every six months post-delivery for two years.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Fetal embolization of vein of Galen malformationExperimental Treatment1 Intervention

This is a single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation.