Fetal Embolization for Severe Vein of Galen Malformation - A Feasibility and Safety Trial
Vein of Galen Malformation
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Femenino
- Voluntarios sanos
- No aceptados
- Participantes
- 10 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
1. Pregnant woman - maternal age 18 years or older
2. Singleton pregnancy
3. Prenatal sonographic evidence of Vein of Galen Malformation (VOGM) between 23-0/7 and 37-0/7 weeks of gestation
4. VOGM volume ratio (VBR) \>9.69% and narrowest mediolateral diameter of the straight or falcine sinus (\>10.15 mm) on prenatal magnetic resonance imaging (MRI)
5. Worsening VOGM severity on follow up prenatal imaging (i.e. ultrasound, MRI and/or echocardiography), and exceeding the specified threshold measurements in any one or more of the following prognostic markers: VOGM varix volume (≥10.9cm3), new or progressive middle cerebral artery pseudofeeders, and/or worsening combined cardiac index (CCI \>750 mL/kg/min).
6. Absence of bilateral extensive brain damage on fetal MRI
7. Absence of significant\* fetal anomalies unrelated to VOGM on fetal US and/or MRI imaging
8. Gestational age at the time of the procedure will be between 30-0/7 and 37-0/7 weeks
9. Negative maternal serological tests for HIV, Hepatitis B and Hepatitis C because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the pregnant woman's HIV status or Hepatitis status is unknown, she must be tested and found to have negative results before enrollment
10. The pregnant woman has considered and declined termination of pregnancy
11. The pregnant woman meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study)
12. Signed informed consent by participant and the father of the baby
- Significant associated anomalies are defined as such anomalies that would, in and of themselves, be life limiting or life threatening. A minor anomaly, such as a small VSD or ASD not deemed to be life limiting or threatening, or a cleft lip or other such anomaly, unless part of a genetic syndrome, will not disqualify the fetus.
Exclusion Criteria:
1. Extensive fetal brain parenchymal injury or gliosis on fetal MRI, defined as greater than one quarter of supratentorial brain volume consistent with advanced irreversible brain injury
2. Severe hydrops fetalis on fetal ultrasound, characterized by large-volume effusions resulting in organ compression, diffuse fetal skin edema, and marked cardiomegaly
3. Increased risk for preterm labor including short cervical length (≤ 2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth in a singleton pregnancy (other than a patient delivered for a non-repeating medical or surgical indication)
4. Placental abnormalities (previa, abruption, accreta) known at time of enrollment
5. Pre-pregnancy body-mass index (BMI) ≥40
6. Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment
7. Technical limitations precluding fetal surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies
8. Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
9. Maternal medical condition that is a contraindication to surgery or anesthesia, i.e. any inadequately controlled maternal medical condition resulting in an American Society of Anesthesiologists (ASA) Physical Status classification of III or higher
10. Low amniotic fluid volume (Amniotic Fluid Index less than 5cm), unresponsive to maternal hydration, if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture
11. The pregnant woman does not have a support person (i.e., spouse, partner, family member, or close friend) available to support her for the duration of the pregnancy
12. Inability to comply with the travel and follow-up requirements of the trial
13. The pregnant woman has severe depression and has not been cleared by a psychiatrist
14. The pregnant woman is enrolled or has been enrolled in any another intervention study that affects the mother or fetus
15. Maternal contraindications to nonionic contrast agent such as acute thyroid dysfunction and acute kidney injury
16. Maternal hypersensitivity to any of the entities associated with the use of nonionic contrast agent. The use of Omnipaque distributed by GE Healthcare company is contraindicated for participants sensitive to any of the components listed on the container package, i.e. Iohexol (Bis(2,3-dihydroxypropyl)-5-\[N-(2,3-dihydroxypropyl)-acetamido\]-2,4,6-triiodoisophthalamide), edetate calcium disodium and tromethamine
17. Maternal hypersensitivity to any of the entities associated with the use of liquid embolic system. The use of Trufill (n-BCA) distributed by Cerenovus - Johnson\&Johnson company is contraindicated for participants sensitive to any of the components listed on the container, i.e. n-BCA, Ethiodized Oil and Tantalum Powder
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Fetal Embolization
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
Fetal embolization of severe Vein of Galen Malformation using a liquid embolic system COMBINATION_PRODUCT
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: 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
If the fetal survives to delivery and discharge from the neonatal intensive care unit (NICU)
Medidas secundarias
Feasibility of FETTUS in Cases of Severe Vein of Galen Malformation
Plazo: At the end of the fetal embolization procedure
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
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: At the end of the fetal embolization procedure
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
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: At the end of the fetal embolization procedure
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
1. Contrast agent (cumulative contrast dose)
2. Cumulative radiation dose
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks
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
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
Maternal length of stay (in days)
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: From date of fetal embolization to date of delivery, assessed up to 10 weeks
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
1. Intrauterine growth restriction (IUGR)
2. Intrauterine fetal demise (IUFD)
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: From date of fetal embolization to date of delivery, assessed up to 10 weeks
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
Gestational age at delivery
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: From date of fetal embolization to date of delivery, assessed up to 10 weeks
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
Birth weight (grams)
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: From date of fetal embolization to date of delivery, assessed up to 10 weeks
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
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: From date of fetal embolization to date of delivery, assessed up to 10 weeks
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
Umbilical artery pH
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: At hospital discharge or date of death, whichever came first, assessed up to 24 months
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
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: At hospital discharge or date of death, whichever came first, assessed up to 24 months
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
Number of events related to glue migration
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: At hospital discharge or date of death, whichever came first, assessed up to 24 months
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)
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: At 12 and 24 months of age
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
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: At 12 and 24 months of age
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
Neurodevelopmental outcomes (Developmental Profile Assessment, Capute Scales, Revised Gesell Developmental Schedules)
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: From date of fetal embolization to date of delivery, assessed up to 10 weeks
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
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Plazo: From date of fetal embolization to date of delivery, assessed up to 10 weeks
Maternal morbidity and mortality will be assessed using the following outcomes:
Number of events related to glue migration
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Texas Children's HospitalHouston, Texas, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- Michael A Belfort
- Inicio del estudio
- 2027-03 Estimado
- Finalización primaria
- 2032-12 Estimado
- Finalización del estudio
- 2035-12 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Fetal Embolization Via Transcardiac Transarterial Ultrasound and Fluoroscopy-guided Endovascular Surgery (FETTUS) for Severe Vein of Galen Malformation - A Feasibility and Safety Trial
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026