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FETO for Diaphragmatic Hernia (FETO Trial)
FETO Trial Summary
This trial will study whether a Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy can help improve survival for fetuses with the most severe form of Congenital Diaphragmatic Hernia (CDH).
FETO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FETO Trial Design
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Who is running the clinical trial?
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- I am pregnant and 18 years or older.It's not safe or possible to place a balloon in my womb using a scope.I do not have HIV or Hepatitis, or I have tested negative for them.I have had a weak cervix, with or without a stitch.I have a uterine condition like fibroids or a developmental abnormality.I am willing and able to follow the study's requirements.My condition involves significant genetic or physical abnormalities affecting survival.My prenatal tests show no genetic abnormalities.I have a health condition that prevents me from having surgery during pregnancy.My unborn baby has a severe lung condition diagnosed between 18 to 29 weeks of pregnancy.
- Group 1: FETO with GOLDBAL2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the current magnitude of participants in this medical experiment?
"Indeed, clinicaltrials.gov data affirms that recruitment for this investigation is ongoing; the study was first published on 9/18/2022 and revised most recently on 9/19/2022. 10 participants must be sourced from a single site to complete the trial."
What are the core aims of this investigation?
"This clinical trial, occurring over a period of 27 to 29 weeks, will be assessing the number of successful balloon removals. Secondary objectives include measuring changes in fetal lung growth (by comparing observed-to-expected lung to head ratios before and after balloon removal), collecting data on infants requiring extra corporeal membrane oxygenation support (from medical chart review) and noting instances of intraventricular hemorrhage among participants (again from medical chart review)."
Are medical professionals currently in the process of seeking participants for this experiment?
"Indeed, the information available on clinicaltrials.gov suggests that this research endeavour is actively seeking participants. This investigation was initially posted on September 18th 2022 and has been recently updated on September 19th 2022. At present, 10 test subjects are being recruited from a single medical centre."
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