Fetal Embolization for Severe Vein of Galen Malformation - A Feasibility and Safety Trial

ClinicalTrials.gov ID: NCT07927725

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Official title

Fetal Embolization Via Transcardiac Transarterial Ultrasound and Fluoroscopy-guided Endovascular Surgery (FETTUS) for Severe Vein of Galen Malformation - A Feasibility and Safety Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07927725
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: Michael A Belfort; Other
Enrollment: 10 participants

Conditions and interventions

Conditions

Vein of Galen Malformation

Interventions

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

Combination Product

Eligibility (public fields only)

Age range: 18 Years and older
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 2027 (Estimated)
Primary completion: Dec 2032 (Estimated)
Completion: Dec 2035 (Estimated)
Last update posted: Nov 10, 2026

2027 – 2035

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Texas Children's Hospital	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07927725, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 10, 2026 · Synced Nov 13, 2026