An interventional study of Fetal embolization of severe Vein of Galen Malformation using a liquid embolic system in Vein of Galen Malformation, sponsored by Michael A Belfort. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Michael A Belfort · Not applicable, Interventional, and Treatment
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.
Participants will be offered the FETTUS technique as an alternative to the traditional standard postnatal VOGM embolization if all study criteria are met. During the surgery, the mother's uterus is exteriorized using the standard laparotomy approach that we currently use for our fetoscopic spina bifida repair and then transuterine fetal cardiac access is obtained under continuous ultrasound guidance. Once the needle is in place, a microcatheter is advanced through the blood vessels in the heart and up to the site of the malformation in the brain. The malformation will be embolized using medical-grade glue (Trufill n-BCA Liquid Embolic System, Johnson \& Johnson)
All participants will be closely followed with postoperative ultrasound scans and consultations. Delivery will be scheduled at Texas Children's Hospital, and the infants will be followed by our research team until they reach 24 months of age.
79 studies on the registry are indexed under Vascular Malformations; 33 are open to participants now.
This study's planned enrollment of 10 is below the median of 55 across 49 interventional studies indexed under Vascular Malformations.
Browse Vascular Malformations studies →Michael A Belfort is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed by participant and the father of the baby
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a single arm study in which participants will undergo a one-time intervention of fetal embolization for severe Vein of Galen Malformation.
Combination Product: Fetal embolization of severe Vein of Galen Malformation using a liquid embolic system
Participants will undergo a laparotomy, exteriorization of the uterus, and uterine needle puncture to obtain fetal cardiac access so a catheter can be inserted into an artery and guided up to the site of the malformation. A liquid embolic system (Trufill n-Butyl CyanoAcrylate, Johnson \& Johnson) will be used to occlude the dominant arterial pedicle supplying the shunt.
Also known as: FETTUS
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
If the fetal survives to delivery and discharge from the neonatal intensive care unit (NICU)
Time frame: From the date of fetal embolization until the date of discharge from the NICU, or the date of death from any cause, whichever came first, assessed up to 24 months
Feasibility of FETTUS in Cases of Severe Vein of Galen Malformation
If all of the following occurs: 1. There is successful embolization of the target feeding artery 2. The fetus survives through the end of the embolization procedure
Time frame: At the end of the fetal embolization procedure
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: 1. Fetal Demise 2. Fetal bradycardia/arrhythmia 3. Hydrops fetalis 4. Fetal intracranial hemorrhage 5. Emergent delivery
Time frame: At the end of the fetal embolization procedure
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: 1. Contrast agent (cumulative contrast dose) 2. Cumulative radiation dose
Time frame: At the end of the fetal embolization procedure
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: 1. Fetal demise 2. Fetal intracranial hemorrhage 3. Need for emergent delivery
Time frame: From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: Maternal length of stay (in days)
Time frame: From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: 1. Intrauterine growth restriction (IUGR) 2. Intrauterine fetal demise (IUFD)
Time frame: From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: Gestational age at delivery
Time frame: From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: Birth weight (grams)
Time frame: From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: 1. Bicêtre VOGM prognosis score (0-21) 2. APGAR scores 3. Number of events related to glue migration
Time frame: From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: Umbilical artery pH
Time frame: From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: 1. Neonatal or infant death 2. Cardiac arrhythmia and/or reduced ejection fraction on echocardiography 3. Focal neurological deficit 4. Seizure 5. Stroke (hemorrhagic vs. focal non-hemorrhagic) 6. Global cortical atrophy or gliosis 7. Delayed myelination 8. Arteriovenous shunting 9. Liver failure 10. Renal failure 11. Thyroid dysfunction 12. Complications related to prematurity
Time frame: At hospital discharge or date of death, whichever came first, assessed up to 24 months
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: Number of events related to glue migration
Time frame: At hospital discharge or date of death, whichever came first, assessed up to 24 months
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: 1. Duration of intubation (days) 2. Time on pressors (in days) 3. Time on treatment for pulmonary hypertension (in days) 4. Time to initiation of enteral feeds (in days) 5. Time on total parenteral nutrition (TPN) (in days) 6. Length of hospital stay (in days)
Time frame: At hospital discharge or date of death, whichever came first, assessed up to 24 months
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: 1. Infant Death 2. Need for additional embolizations 3. Renal failure 4. Thyroid dysfunction 5. Stroke (hemorrhagic vs. focal non-hemorrhagic) 6. Global cortical atrophy or gliosis 7. Delayed myelination 8. Arteriovenous shunting 9. Hydrocephalus 10. Focal neurological deficit 11. Seizure
Time frame: At 12 and 24 months of age
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Fetal and infant morbidity and mortality will be assessed using the following outcomes: Neurodevelopmental outcomes (Developmental Profile Assessment, Capute Scales, Revised Gesell Developmental Schedules)
Time frame: At 12 and 24 months of age
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Maternal morbidity and mortality will be assessed using the following outcomes: 1. Mortality 2. Contrast-agent-related complications 3. Anesthesia complications 4. Pulmonary edema 5. Need for blood transfusion 6. Wound infection. 7. Chorioamniotic membrane separation 8. Chorioamnionitis 9. Oligohydramnios 10. Preterm labor 11. Preterm delivery 12. Preterm premature rupture of membranes 13. Placental abruption 14. Maternal postoperative readmission for a procedure-related complication
Time frame: From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Maternal morbidity and mortality will be assessed using the following outcomes: Number of events related to glue migration
Time frame: From date of fetal embolization to date of delivery, assessed up to 10 weeks
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Michael A Belfort