Fetal Embolization for Vein of Galen Malformation

This trial explores a treatment for fetuses with vein of Galen malformation, a rare abnormality in the brain's blood vessels. The trial aims to determine if fetal embolization is a safe and effective treatment for this condition before birth. The procedure uses detachable coils (Target XL and XXL Detachable Coils) to block the abnormal blood vessels. Pregnant women carrying a fetus diagnosed with this malformation, as confirmed by specific imaging criteria, may be suitable candidates. Participants will receive regular check-ups during pregnancy and follow-ups for two years after delivery to monitor the baby’s neurological development. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could improve outcomes for future patients.

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulation medication, you may not be eligible to participate.

Research shows that using Target XL and XXL Detachable Coils to treat Vein of Galen Malformation (VOGM) in unborn babies is a new method, and researchers are still collecting safety information. Previous studies have not specifically examined this treatment in fetuses. The goal is to determine if the treatment is safe and effective before birth. One study discussed the safety of this procedure during pregnancy, but clear data on side effects or risks is not yet available. Currently, the treatment is intended to be safe, but more evidence is needed. Participants will have regular check-ups to monitor any effects and ensure safety.¹²³⁴⁵

Unlike traditional treatments for vein of Galen malformation, which typically involve postnatal surgical interventions, the fetal embolization approach using Target XL and XXL Detachable Coils offers a groundbreaking prenatal solution. This technique is unique because it allows for intervention while the baby is still in the womb, potentially reducing the risk of heart failure and brain damage associated with this condition. Researchers are excited about this method as it targets the malformation early, which could lead to better outcomes by preventing severe symptoms before birth.

Research has shown that using Target XL and XXL Detachable Coils might help treat Vein of Galen Malformation (VOGM). This trial involves a single-arm study where fetal subjects undergo a one-time intervention of fetal embolization using these coils. The method places tiny coils in the abnormal blood vessels to block them. Although direct data on using this procedure in unborn babies is limited, similar methods in older patients have shown promise in reducing blood flow problems caused by VOGM. The aim of using these coils is to prevent complications before birth, potentially leading to better outcomes. Early findings suggest this treatment might help manage the condition, but more research is needed to confirm its effectiveness in unborn babies.¹²³⁴⁵