Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04434729
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2020-06-13
Brief Title:
Fetal Treatment of Galenic Malformations
Sponsor:
Darren Orbach
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Fetal Treatment of Galenic Malformations
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Womens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020P000216 | OTHER | Partners Healthcare IRB | None |