Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of fetal embolization for patients with vein of Galen malformations | Primary outcome/endpoint: mortality measured from birth to day 30 of life. | Birth to day 30 of life |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Darren Orbach, MD PhD | Contact | 617-355-5012 | Darren.Orbach@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Darren Orbach, MD PhD | Boston Children's Hospital, Boston, MA 02115 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054080 | Vein of Galen Malformations |
| ID | Term |
|---|---|
| D002538 | Intracranial Arteriovenous Malformations |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | 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. | 6 months through 24 months |
| D009422 | Nervous System Diseases |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |