RecruitingNot ApplicableNCT07483255

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

Sponsor

Darren Orbach

Enrollment

20 participants

Start Date

Jul 20, 2026

Study Type

INTERVENTIONAL

Conditions

Vein of Galen Malformations

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils for people with vein of galen malformations. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils

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.

Locations(1)

Boston Children's Hospital

Boston, Massachusetts, United States

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NCT07483255