Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
(FETO Trial)
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).
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the use of detachable balloons in medical procedures generally safe?
How does the Fetal Endoscopic Tracheal Occlusion treatment differ from other treatments for congenital diaphragmatic hernia?
The Fetal Endoscopic Tracheal Occlusion (FETO) treatment is unique because it involves placing a detachable balloon in the fetus's trachea to promote lung growth before birth, which is different from traditional surgical approaches that are performed after birth. This prenatal intervention aims to improve lung development in cases of congenital diaphragmatic hernia, offering a novel approach compared to postnatal surgical repairs.678910
Research Team
Rodrigo Ruano, MD, Ph.D
Principal Investigator
University of Miami
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 maternal health risks. The gestational age must be between 27 weeks and 31 weeks 6 days at the time of the FETO procedure, depending on specific lung-to-head ratio measurements.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
FETO Procedure
Participants undergo fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system
Delivery and Immediate Postpartum
Monitoring of maternal and fetal outcomes, including gestational age at delivery and maternal complications
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pulmonary hypertension, oxygen dependency, and other infant health outcomes
Treatment Details
Interventions
- BALT GoldbBAL2 Detachable Balloon
- Catheter System
- Fetal Endoscopic Tracheal Occlusion
BALT GoldbBAL2 Detachable Balloon is already approved in European Union for the following indications:
- Congenital Diaphragmatic Hernia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rodrigo Ruano M.D., Ph.D
Lead Sponsor
Rodrigo Ruano
Lead Sponsor