Trial Summary
What is the purpose of this trial?The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Eligibility Criteria
This trial is for pregnant individuals with a single fetus diagnosed with severe left-sided Congenital Diaphragmatic Hernia (CDH) and liver up, without other fetal anomalies or chromosomal abnormalities. The fetus must have a specific lung-to-head ratio indicating pulmonary hypoplasia, and the gestational age should be between 27 to just under 32 weeks at the time of surgery.Inclusion Criteria
My condition involves the left side of my diaphragm being affected with my liver positioned higher.
My baby's genetic test results are normal.
You are pregnant with only one baby.
+3 more
Exclusion Criteria
I do not have HIV, Hepatitis-B, or Hepatitis-C.
My unborn baby has been diagnosed with additional anomalies or chromosomal abnormalities.
My baby has a right-sided or bilateral diaphragmatic hernia, or an isolated left-sided one with specific ultrasound measurements.
+10 more
Participant Groups
The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO), using BALT GoldbBAL2 Detachable Balloon and Catheter System. This procedure aims to improve lung development in fetuses with CDH by temporarily blocking their trachea.
1Treatment groups
Experimental Treatment
Group I: FETO GroupExperimental Treatment2 Interventions
Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.
BALT GoldbBAL2 Detachable Balloon is already approved in European Union for the following indications:
🇪🇺 Approved in European Union as BALT GoldbBAL2 Detachable Balloon for:
- Congenital Diaphragmatic Hernia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
Rodrigo RuanoLead Sponsor