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Vascular Embolization Device
Fetal Embolization for Vein of Galen Malformation
N/A
Recruiting
Led By Darren Orbach, MD PhD
Research Sponsored by Darren Orbach
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Maternal age of 18 years and older
Pregnant woman carrying a fetus harboring a vein of Galen malformation in whom the straight sinus or falcine sinus draining the prosencephalic varix measures 8 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of birth
Awards & highlights
Study Summary
This trial will test a new treatment for a birth defect called Vein of Galen Malformation. One-time fetal embolization will be done, and then the baby will be monitored regularly. Data from this trial will be compared to past cases.
Who is the study for?
This trial is for pregnant women with a fetus diagnosed with Vein of Galen Malformation (VOGM), where the affected sinus measures at least 8 mm. The mother must be over 18, able to travel for study visits, and have a well-preserved fetal brain structure. Exclusions include preterm labor risks, maternal coagulopathy or diseases requiring anticoagulation, prior conditions preventing epidural anesthesia, multiple pregnancies, placenta issues, other conflicting studies participation, metal hypersensitivity and severe obesity.Check my eligibility
What is being tested?
The trial tests fetal embolization using Target XL and XXL Detachable Coils on fetuses with VOGM to evaluate safety and effectiveness. It's a single-arm study comparing results against historical data. Participants undergo one-time embolization followed by regular check-ups until delivery and neurological assessments every six months post-delivery for two years.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include complications from the embolization procedure such as bleeding or damage to surrounding tissues in the fetus or adverse reactions related to the coils used in treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am pregnant and my fetus has a specific brain vessel malformation diagnosed by MRI.
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I am a candidate for continuous lower back pain relief through an epidural.
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My unborn baby has been diagnosed with a vein of Galen malformation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from fetal embolization to delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from fetal embolization to delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prenatal safety of fetal embolization for patients with vein of Galen malformations
Secondary outcome measures
Efficacy of fetal embolization for patients with vein of Galen malformations
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fetal embolization of vein of Galen malformationExperimental Treatment1 Intervention
This is a single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation.
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Who is running the clinical trial?
Darren OrbachLead Sponsor
Darren Orbach, MD PhDPrincipal Investigator - Boston Children's Hospital
Boston Children's Hospital, Children's Hospital Radiology Foundation Inc, Dana-Farber Cancer Institute
Joan And Stanford I. Weill Medical College Of Cornell Uni (Medical School)
Ny University Medical Center (Residency)
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are showing signs of early labor, water breaking, or separation of the placenta.Unborn babies with a specific type of brain blood vessel abnormality that measures less than 8 mm on a special type of MRI test will not be included in the study.Unborn babies with serious birth defects.I am 18 years old or older.I am pregnant and my fetus has a specific brain vessel malformation diagnosed by MRI.You are pregnant with more than one baby.You have a clotting problem, with blood tests showing abnormal values for INR, PT, PTT, or low platelet count.I am a candidate for continuous lower back pain relief through an epidural.My brain tissue is healthy.My unborn baby has been diagnosed with a vein of Galen malformation.If the mother had a medical condition that would make it unsafe for her to have epidural anesthesia.I am on blood thinners for a medical condition, like a deep vein thrombosis.The baby is between 23 weeks and full term according to the first ultrasound and other clinical information.You are already taking part in another study that affects the health of you and your baby.You are very overweight before getting pregnant, with a body mass index (BMI) of 40 or higher.You have placenta previa or accreta.You are allergic to 316LM stainless steel.You have extensive damage and scarring in more than 10% of the upper part of your brain.I can travel to the study location for all required visits.The baby has a serious non-brain organ injury that cannot be reversed, such as severe heart failure before birth.
Research Study Groups:
This trial has the following groups:- Group 1: Fetal embolization of vein of Galen malformation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for enrollment in this experiment currently available?
"Affirmative. The clinical trial was first made available on September 1st 2022 and has recently been updated by the research team on February 8th 2022. Currently, 20 individuals are being sought out at a single site for participation in this study."
Answered by AI
What is the participant cap for this research endeavor?
"Indeed, clinicaltrials.gov indicates that the study is actively recruiting participants. It was first posted on September 1st 2022 and its most recent update occurred on February 8th 2022. The research initiative hopes to enroll approximately 20 patients across a single site."
Answered by AI
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