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ACTIVE NOT RECRUITING
NCT04434729
NA

Fetal Treatment of Galenic Malformations

Sponsor: Darren Orbach

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm non-randomized interventional study of fetuses to assess the safety and efficacy of fetal embolization of Vein of Galen Malformation (VOGM). Subjects will receive a one-time study intervention of fetal embolization. Follow-up assessments will be collected every 4 weeks until delivery, as per standard of care. 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

7

Start Date

2022-09-30

Completion Date

2026-08

Last Updated

2026-01-06

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