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NOT YET RECRUITING
NCT07483255
NA

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

Sponsor: Darren Orbach

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-05

Completion Date

2032-12

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DEVICE

Fetal 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