Vein of Galen MalformationsNCT07483255
A Phase II Trial of Fetal Embolization for Vein of Galen Malformation
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 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. 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 or axial slice).
- Fetal gestational age of 34 weeks or more at the time of the planned fetal intervention, as determined by clinical information and evaluation of first ultrasound. The suitability for fetal treatment, in terms of technical/positional factors, will be assessed on a case-by-case basis by the MFM, ultrasonographer, and neurointerventionalist participating in the study.
- Anatomic diagnosis of fetal vein of Galen malformation. Various cerebrovascular conditions, such as dural sinus malformation and pial arteriovenous fistula, can result in dilated intracranial vascular structures being visualized in utero. Similarly, fetal dilatation of the vein of Galen can occasionally be seen without the presence of an arteriovenous lesion at all, as a benign venous variant. This condition is readily distinguishable sonographically from VOGM by virtue of the presence of dilated arterial feeding pedicles, and by the presence of an arterial waveform within the varix. This study is aimed solely at fetuses with an established diagnosis of vein of Galen malformation.
Who cannot join
- Extensive fetal brain parenchymal injury/gliosis, i.e. >10% of supratentorial brain volume (SFP presentation). In some cases, significant bihemispheric cerebral parenchymal injuries are seen at the time of initial fetal diagnosis of vein of Galen malformation (SFP cohort). Such fetuses rarely survive, but if they do, are profoundly neurodevelopmentally impaired: typically blind, mute, quadriparetic, often with unremitting intractable seizures, and permanently bed-bound and uncommunicative. As there is no realistic possibility of achieving a good neurological outcome in such patients, fetuses with diffuse bihemispheric brain injury will be excluded.
- 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).
- 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 or axial 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 extracranial 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
- Any maternal use of anticoagulants, whether prophylactic or therapeutic.
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Darren Orbach, MD, 617-355-5012, darren.orbach@childrens.harvard.edu
About this study
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.
Read the detailed description
The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization for fetuses with vein of Galen malformations (VOGM) with a falcine sinus (FS) width of >= 7 mm (study population). 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 OR at Boston Children's Hospital. Data regarding pre-delivery, delivery and post-delivery status will be collected until the subject is discharged from the hospital. After delivery, neurological assessments will be performed on the child 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 |
|---|---|---|
| Single Arm | Experimental | This is an open-label, 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.
Efficacy of fetal embolization for patients with vein of Galen malformations
Primary outcome/endpoint: mortality measured from birth to day 30 of life.
Measured: Birth to day 30 of life
Secondary outcomes (4)
Safety of fetal embolization of patients with vein of Galen malformations
Safety outcomes/endpoint: the incidence of the following serious adverse events (SAEs) from Day 0 (the day of fetal intervention) till birth, as measured by number of events experienced across the number of participants enrolled:
- Fetal intraparenchymal hemorrhage with mass effect, likely related to the procedure
- Fetal territorial ischemic infarct, likely related to the procedure
- Procedure-related fetal hemorrhage, either intracranial or extracranial, requiring transfusion
- Maternal hemorrhage requiring blood transfusion
- Procedure-related placental injury requiring urgent Caesarian section
Measured: Day of fetal intervention to 24 months of age
Brain parenchymal injury
The incidence of brain parenchymal injury on the first postnatal scan will be collected and compared to a historical cohort that did not undergo fetal intervention.
Measured: Birth to first postnatal scan
Neurodevelopmental milestones at 6 months
A neurological assessment will be performed at 6 months adjusted gestational age using Vineland Adaptive Behavior Scales and the Receptive-Expressive Emergent Language Test. Scores for enrolled participants will be compared to scores from a historical cohort at a similar age.
Measured: Birth through 6 months
Neurodevelopmental milestones 6 months through 24 months
Neurological assessments will be performed from 6 months adjusted gestational age to 24 months adjusted gestational age using Vineland Adaptive Behavior Scales and the Receptive-Expressive Emergent Language Test, Child Behavior Checklist, DAYC-2 cognitive assessment, and the Bayley examination (if seen in person). Scores for enrolled participants will be compared to scores from a historical cohort at a similar age.
Measured: 6 months through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start20 Jul 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (estimated)
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, Boston, MA 02115
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483255
- Sponsor's protocol ID
- P00052699
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Fetal Embolization for Vein of Galen Malformation
- ClinicalTrials.gov ID
- NCT07483255
- Acronym / sponsor ID
- P00052699
- Conditions
- Vein of Galen Malformations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Darren OrbachUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
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 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.
Detailed description
The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization for fetuses with vein of Galen malformations (VOGM) with a falcine sinus (FS) width of >= 7 mm (study population). 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 OR at Boston Children's Hospital. Data regarding pre-delivery, delivery and post-delivery status will be collected until the subject is discharged from the hospital. After delivery, neurological assessments will be performed on the child 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 |
|---|---|---|
| Single Arm | Experimental | Device: Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable CoilsThis is an open-label, 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 (3 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 or axial slice).
- Fetal gestational age of 34 weeks or more at the time of the planned fetal intervention, as determined by clinical information and evaluation of first ultrasound. The suitability for fetal treatment, in terms of technical/positional factors, will be assessed on a case-by-case basis by the MFM, ultrasonographer, and neurointerventionalist participating in the study.
- Anatomic diagnosis of fetal vein of Galen malformation. Various cerebrovascular conditions, such as dural sinus malformation and pial arteriovenous fistula, can result in dilated intracranial vascular structures being visualized in utero. Similarly, fetal dilatation of the vein of Galen can occasionally be seen without the presence of an arteriovenous lesion at all, as a benign venous variant. This condition is readily distinguishable sonographically from VOGM by virtue of the presence of dilated arterial feeding pedicles, and by the presence of an arterial waveform within the varix. This study is aimed solely at fetuses with an established diagnosis of vein of Galen malformation.
Key exclusion criteria (14 listed)
- Extensive fetal brain parenchymal injury/gliosis, i.e. >10% of supratentorial brain volume (SFP presentation). In some cases, significant bihemispheric cerebral parenchymal injuries are seen at the time of initial fetal diagnosis of vein of Galen malformation (SFP cohort). Such fetuses rarely survive, but if they do, are profoundly neurodevelopmentally impaired: typically blind, mute, quadriparetic, often with unremitting intractable seizures, and permanently bed-bound and uncommunicative. As there is no realistic possibility of achieving a good neurological outcome in such patients, fetuses with diffuse bihemispheric brain injury will be excluded.
- 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).
- 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 or axial 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 extracranial 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 | Single Arm |
Primary outcome
Efficacy of fetal embolization for patients with vein of Galen malformations
Time frame: Birth to day 30 of life
Primary outcome/endpoint: mortality measured from birth to day 30 of life.
4 secondary outcomes
Safety of fetal embolization of patients with vein of Galen malformations
Time frame: Day of fetal intervention to 24 months of age
Brain parenchymal injury
Time frame: Birth to first postnatal scan
Neurodevelopmental milestones at 6 months
Time frame: Birth through 6 months
Neurodevelopmental milestones 6 months through 24 months
Time frame: 6 months through 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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.
Darren Orbach, MD PhD principal investigator
Boston Children's Hospital, Boston, MA 02115
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 3 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: looking for participants now, as of the sponsor's last update on 23 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darren Orbach, MD PhD (617-355-5012, Darren.Orbach@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of fetal embolization for patients with vein of Galen malformations (time frame: Birth to day 30 of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.