Sponsor study identifier
Secondary identifiers
OTHER · Partners Healthcare IRB
interventional
7
1 country
1
Study Start
September 30, 2022
Actual (reported)Primary Completion
September 6, 2024
Actual (reported)Study Completion
September 21, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 21, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 13, 2020
Actual (reported)June 17, 2020
Actual (reported)September 30, 2022
Actual (reported)September 6, 2024
Actual (reported)January 6, 2026
Actual (reported)September 21, 2026
Actual (reported)Prenatal Safety of Fetal Embolization for Patients With Vein of Galen Malformations
The procedure is deemed safe if 1. None of the following unacceptable events occur within 7 days of fetal embolization: 1. Fetal death 2. Fetal intracranial hemorrhage, either parenchymal or extra-axial, other than petechial hemorrhage. 3. Maternal death 2. None of the following unacceptable events occur between fetal embolization and delivery: 1. Intra-procedural and post-procedural morbidity to the fetus and mother, probably related to the fetal intervention, e.g. placental abruption with subsequent sequelae 2. Preterm delivery \< 28 weeks, probably related to the fetal intervention 3. Maternal blood transfusion or unanticipated surgical intervention, probably related to the fetal intervention 4. Presence of fetal imaging evidence of new brain injury in a location or pattern unexpected for the natural history of vein of Galen malformation, probably related to the fetal intervention
From fetal embolization to delivery
Efficacy of Fetal Embolization for Patients With Vein of Galen Malformations
Within 30 days of birth
This is a single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Orbach DB, Shamshirsaz AA, Wilkins-Haug L, Guseh S, Krispin E, Tworetzky W, O'Leary B, Larson AM, Rangwala SD, Oushy S, See AP. In Utero Embolization for Fetal Vein of Galen Malformation. JAMA. 2025 Sep 9;334(10):878-885. doi: 10.1001/jama.2025.12363.
Orbach DB, Wilkins-Haug LE, Benson CB, Tworetzky W, Rangwala SD, Guseh SH, Gately NK, Stout JN, Mizrahi-Arnaud A, See AP. Transuterine Ultrasound-Guided Fetal Embolization of Vein of Galen Malformation, Eliminating Postnatal Pathophysiology. Stroke. 2023 Jun;54(6):e231-e232. doi: 10.1161/STROKEAHA.123.043421. Epub 2023 May 4. No abstract available.
Darren Orbach, MD PhD
Boston Children's Hospital
7 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2020
First Posted
June 17, 2020
Study Start
September 30, 2022
Actual (reported)Contact the study team to confirm eligibility.
See AP, Wilkins-Haug LE, Benson CB, Tworetzky W, Orbach DB. Percutaneous transuterine fetal cerebral embolisation to treat vein of Galen malformations at risk of urgent neonatal decompensation: study protocol for a clinical trial of safety and feasibility. BMJ Open. 2022 May 24;12(5):e058147. doi: 10.1136/bmjopen-2021-058147.
Primary Completion
September 6, 2024
Actual (reported)Study Completion
September 21, 2026
Actual (reported)Last Updated
October 21, 2026
Results First Posted
January 6, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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