Fetal Embolization for Severe Vein of Galen Malformation - A Feasibility and Safety Trial
NCT07927725, Not applicable, Not yet recruiting, Michael A Belfort
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Fetal Embolization for Severe Vein of Galen Malformation - A Feasibility and Safety Trial | ClinicalTrials.gov |
| NCT number | NCT07927725 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 10 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Michael A Belfort | ClinicalTrials.gov |
| Conditions | Vein of Galen Malformation | ClinicalTrials.gov |
| Interventions | Fetal embolization of severe Vein of Galen Malformation using a liquid embolic system | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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) | ClinicalTrials.gov |
| Secondary | Feasibility of FETTUS in Cases of Severe Vein of Galen Malformation | 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 | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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 | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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 | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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 | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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) | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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) | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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 | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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) | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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 | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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 | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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 | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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 | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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) | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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 | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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) | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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 | ClinicalTrials.gov |
| Secondary | Safety of FETTUS in Cases of Severe Vein of Galen Malformations | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)