Fetoscopic Surgery for Congenital Diaphragmatic Hernia
(FETO Trial)
Trial Summary
Do I need to stop my current medications for the 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.
What data supports the effectiveness of the treatment Fetoscopic Endoluminal Tracheal Occlusion (FETO) for congenital diaphragmatic hernia?
Is fetoscopic surgery for congenital diaphragmatic hernia generally safe?
Fetoscopic surgery, specifically Fetoscopic Endoluminal Tracheal Occlusion (FETO), has been studied for its safety in treating congenital diaphragmatic hernia. While it can improve survival rates, there are concerns about potential complications like tracheomegaly (enlarged windpipe) and tracheomalacia (softening of the windpipe), which may affect breathing.12456
How is the treatment Fetoscopic Endoluminal Tracheal Occlusion (FETO) different from other treatments for congenital diaphragmatic hernia?
Fetoscopic Endoluminal Tracheal Occlusion (FETO) is unique because it involves a minimally invasive procedure where a balloon is placed in the fetus's trachea (windpipe) to promote lung growth before birth, which is different from traditional postnatal surgeries that address the hernia after birth. This approach aims to improve lung development and increase survival rates in severe cases of congenital diaphragmatic hernia.12345
What is the purpose of this trial?
The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.
Eligibility Criteria
This trial is for pregnant women over 18 with a single pregnancy and a fetus diagnosed with severe right or left Congenital Diaphragmatic Hernia (CDH), where the liver has moved up. The baby must have severely underdeveloped lungs, confirmed by ultrasound measurements, and enrollment should be before 29 weeks plus 6 days of gestation.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
FETO Procedure
Fetoscopic Endoluminal Tracheal Occlusion (FETO) is performed to place the tracheal balloon
Monitoring and Management
Monitoring of maternal and fetal health, including management of pregnancy during tracheal occlusion
Balloon Removal
Removal of the Balt Goldbal2 balloon prior to delivery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fetoscopic Endoluminal Tracheal Occlusion
Fetoscopic Endoluminal Tracheal Occlusion is already approved in United States, European Union for the following indications:
- Severe congenital diaphragmatic hernia (CDH)
- Severe congenital diaphragmatic hernia (CDH)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor