CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 7 enrolled
Drug / intervention
Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coilsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04434729
NCT04434729N/AActive
CompareCT.gov

Fetal Treatment of Galenic Malformations

Darren Orbach·interventional·Posted Jun 17, 2020·Updated Jan 6, 2026

In Brief

A clinical study evaluating Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils for Vein of Galen Malformations. Active but no longer recruiting, targeting 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVein of Galen Malformations
CountriesUnited States
Collaborators--

Timeline

N/AActive
202120222023202420252026
First PostedJun 17, 2020
Enrollment StartSep 30, 2022
Primary CompletionSep 6, 2024
Study CompletionAug 1, 2026
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.0 years ago

Interventions

Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coilsdevice

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.