Vein of Galen MalformationsNCT04434729
Fetal Treatment of Galenic Malformations
A study testing Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils in people with Vein of Galen Malformations, run by Darren Orbach at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vein of Galen Malformations
- What is being tested?
- Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 21 Sep 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant woman carrying a fetus harboring a vein of Galen malformation in whom the straight sinus or falcine sinus draining the prosencephalic varix measures 7 mm or more on fetal MRI (medio-lateral diameter measured at the narrowest point of the sinus along the rostral-caudal axis, assessed on a T2-weighted coronal slice).
- Fetal gestational age between 23 weeks and term as determined by clinical information and evaluation of first ultrasound.
- Anatomic diagnosis of fetal vein of Galen malformation.
- Well preserved brain parenchyma.
- Maternal age of 18 years and older.
- Eligible for continuous lumbar epidural anesthesia.
- Able to travel to study site for study evaluation, procedures and visits.
Who cannot join
- Extensive fetal brain parenchymal injury/gliosis, >10% of supratentorial brain volume (i.e., SFP presentation). This is a degree of fetal brain injury beyond which the risk of significant neurological morbidity is high, based on studies of prenatal ischemic stroke.
- Irreversible fetal non-brain organ injury (e.g. hydrops fetalis as a manifestation of heart failure, a finding which portends fatal outcome in fetuses with vein of Galen malformation), i.e., SFP presentation.
- Fetus with VOGM in whom the straight sinus or falcine sinus draining the prosencephalic varix measures less than 7 mm on fetal MRI (T2-weighted coronal slice, medio-lateral diameter measured at the narrowest point of the sinus along the anterior-posterior axis), fitting fetal MRI criteria for likely evolution into the IT cohort.
- Severe maternal obesity pre-pregnancy as defined by body mass index (BMI) of 40 or greater.
- Fetuses with major congenital anomalies.
- Evidence of preterm labor, rupture of membranes or abruption.
Show all 14Show fewer
- Maternal coagulopathy: INR > 1.2; PT/PTT above normal ranges for the lab; platelets <100.
- Medical disease requiring current anticoagulation including maternal deep vein thrombosis.
- Prior maternal medical history that would preclude epidural anesthesia.
- Multi-fetal pregnancy.
- Placenta previa or accreta.
- Participation in another fetal study that influences maternal and fetal morbidity and mortality.
- Known maternal hypersensitivity to 316LM stainless steel.
- Supine hypotensive syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
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. This procedure will take place in an obstetric OR at Brigham and Women's Hospital. Data will be collected every 4 weeks post-procedure until delivery, as per standard of care. Data regarding delivery and post-delivery status will also be collected until the subject is discharged from the hospital. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.
- Conditions
- Vein of Galen Malformations
- Being tested
- Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils
- Medical subject headings
- Vein of Galen Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Fetal embolization of vein of Galen malformation | Experimental | This is a single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation. Receives: Device: Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Safety of Fetal Embolization for Patients With Vein of Galen Malformations
The procedure is deemed safe if
- None of the following unacceptable events occur within 7 days of fetal embolization:
- Fetal death
- Fetal intracranial hemorrhage, either parenchymal or extra-axial, other than petechial hemorrhage.
- Maternal death
- None of the following unacceptable events occur between fetal embolization and delivery:
- Intra-procedural and post-procedural morbidity to the fetus and mother, probably related to the fetal intervention, e.g. placental abruption with subsequent sequelae
- Preterm delivery < 28 weeks, probably related to the fetal intervention
- Maternal blood transfusion or unanticipated surgical intervention, probably related to the fetal intervention
- 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
Measured: From fetal embolization to delivery
Secondary outcomes (1)
Efficacy of Fetal Embolization for Patients With Vein of Galen Malformations
The procedure is deemed efficacious if none of the following serious postnatal events occur within 30 days of birth:
- Urgent neonatal embolization is needed. Without fetal intervention, we'd expect 80% of the cohort to require such intervention.
- Neonatal death. Without fetal intervention, we'd expect a mortality rate of 40% in this cohort.
- Brain MRI within the first three weeks after birth reveals parenchymal brain injury (acute infarct or gliosis) affecting > 10% of the supratentorial brain volume. Without fetal intervention, we'd expect 30% of patients in this cohort to show this kind of injury.
Measured: Within 30 days of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start30 Sep 2022
- Primary completion6 Sep 2024
- Study completion21 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vein of Galen MalformationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darren Orbach
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Darren Orbach, Boston Children's Hospital
- Investigators
- Darren Orbach, MD PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434729
- Sponsor's protocol ID
- IRB-P00034727
- Other IDs
- 2020P000216
- Status last verified
- Oct 2026
- First submitted
- 13 Jun 2020
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40788723Orbach 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.
PubMed 37139817See 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.
PubMed 35613814
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Treatment of Galenic Malformations
- ClinicalTrials.gov ID
- NCT04434729
- Acronym / sponsor ID
- IRB-P00034727
- Conditions
- Vein of Galen Malformations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Darren OrbachUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 21 Sep 2026 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. This procedure will take place in an obstetric OR at Brigham and Women's Hospital. Data will be collected every 4 weeks post-procedure until delivery, as per standard of care. Data regarding delivery and post-delivery status will also be collected until the subject is discharged from the hospital. 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetal embolization of vein of Galen malformation | Experimental | Device: Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable CoilsThis is a single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant woman carrying a fetus harboring a vein of Galen malformation in whom the straight sinus or falcine sinus draining the prosencephalic varix measures 7 mm or more on fetal MRI (medio-lateral diameter measured at the narrowest point of the sinus along the rostral-caudal axis, assessed on a T2-weighted coronal slice).
- Fetal gestational age between 23 weeks and term as determined by clinical information and evaluation of first ultrasound.
- Anatomic diagnosis of fetal vein of Galen malformation.
- Well preserved brain parenchyma.
- Maternal age of 18 years and older.
Key exclusion criteria (14 listed)
- Extensive fetal brain parenchymal injury/gliosis, >10% of supratentorial brain volume (i.e., SFP presentation). This is a degree of fetal brain injury beyond which the risk of significant neurological morbidity is high, based on studies of prenatal ischemic stroke.
- Irreversible fetal non-brain organ injury (e.g. hydrops fetalis as a manifestation of heart failure, a finding which portends fatal outcome in fetuses with vein of Galen malformation), i.e., SFP presentation.
- Fetus with VOGM in whom the straight sinus or falcine sinus draining the prosencephalic varix measures less than 7 mm on fetal MRI (T2-weighted coronal slice, medio-lateral diameter measured at the narrowest point of the sinus along the anterior-posterior axis), fitting fetal MRI criteria for likely evolution into the IT cohort.
- Severe maternal obesity pre-pregnancy as defined by body mass index (BMI) of 40 or greater.
- Fetuses with major congenital anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable CoilsThe 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. | Device | Fetal embolization of vein of Galen malformation |
Primary outcome
Prenatal Safety of Fetal Embolization for Patients With Vein of Galen Malformations
Time frame: From fetal embolization to delivery
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
1 secondary outcome
Efficacy of Fetal Embolization for Patients With Vein of Galen Malformations
Time frame: Within 30 days of birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40788723Orbach 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.
- Derived from this study: PubMed 37139817Orbach 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.
- Derived from this study: PubMed 35613814See 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.
- Individual participant dataSharing planned: No
Related trials for Vein of Galen Malformations
Recruiting
A Phase II Trial of Fetal Embolization for Vein of Galen Malformation
Vein of Galen Malformations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Orbach, MD PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils in people with Vein of Galen Malformations, run by Darren Orbach at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenatal Safety of Fetal Embolization for Patients With Vein of Galen Malformations (time frame: From fetal embolization to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434729, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.