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Fetal Embolization for Vein of Galen Malformation

LJ
KC
Overseen ByKaren Chen, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Michael A Belfort
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the feasibility and safety of fetal embolization for severe, otherwise lethal, Vein of Galen Malformation (VOGM) via a laparotomy-assisted approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 participants. The hypothesis is that in utero embolization of severe VOGM will reduce postnatal mortality and morbidity in severe VOGM infants with minimal maternal risks and acceptably low fetal risks.

Who Is on the Research Team?

MB

Michael Belfort, MD, PhD

Principal Investigator

Baylor College of Medicine and Texas Children's Hospital

LJ

Luc Joyeux, MD, PhD

Principal Investigator

Baylor College of Medicine and Texas Children's Hospital

KC

Karen Chen, MD

Principal Investigator

Baylor College of Medicine and Texas Children's Hospital

Are You a Good Fit for This Trial?

This trial is for pregnant women carrying a fetus diagnosed with severe Vein of Galen Malformation, a rare and serious blood vessel problem in the brain that is usually life-threatening after birth.

Inclusion Criteria

I am pregnant and 18 years old or older.
VOGM volume ratio (VBR) >9.69% and narrowest mediolateral diameter of the straight or falcine sinus (>10.15 mm) on prenatal MRI
Gestational age at the time of the procedure between 30-0/7 and 37-0/7 weeks
See 9 more

Exclusion Criteria

Pre-pregnancy BMI ≥40
I have a condition or past surgery that makes uterine surgery unsafe for me.
Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting current pregnancy
See 14 more

What Are the Treatments Tested in This Trial?

Interventions

  • Fetal embolization of severe Vein of Galen Malformation using a liquid embolic system

Trial Overview

Researchers are testing whether treating the baby's brain blood vessel malformation before birth using a special liquid to block abnormal vessels (fetal embolization) is safe and possible. The procedure uses surgery to access the womb.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Fetal EmbolizationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Michael A Belfort

Lead Sponsor

Trials
5
Recruited
510+

Baylor College of Medicine

Collaborator

Trials
1,044
Recruited
6,031,000+

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