A Phase II Trial of Fetal Embolization for Vein of Galen Malformation

Conditions

• Vein of Galen Malformations

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils — DEVICE
  The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization. Detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix.

Study Details

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. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.

Key Dates

Start date

May 31, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2032

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Single Arm
  This is an open-label, single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation.

Primary Outcome Measure

Efficacy of fetal embolization for patients with vein of Galen malformations [ Time Frame: Birth to day 30 of life ]

Central Contacts

• Darren Orbach, MD PhD
  617-355-5012
  [email protected]

Locations (1)

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