10 Participants Needed

Fetoscopic Surgery for Congenital Diaphragmatic Hernia

(FETO Trial)

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Overseen ByElizabeth Torres
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that FETO can improve the survival of infants with severe congenital diaphragmatic hernia, although there are concerns about potential complications like tracheomegaly (enlarged windpipe) and tracheomalacia (softening of the windpipe).12345

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

My unborn baby has a normal chromosome analysis.
I am a pregnant woman, 18 or older, and can give consent.
Singleton pregnancy
See 3 more

Exclusion Criteria

Rubber latex allergy
I am pregnant and under 18.
I have a health condition that prevents me from having surgery during pregnancy.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

FETO Procedure

Fetoscopic Endoluminal Tracheal Occlusion (FETO) is performed to place the tracheal balloon

7 weeks
1 visit (in-person) for procedure

Monitoring and Management

Monitoring of maternal and fetal health, including management of pregnancy during tracheal occlusion

From 27 weeks gestational age up to 39 weeks gestational age

Balloon Removal

Removal of the Balt Goldbal2 balloon prior to delivery

Within 5 weeks prior to delivery
1 visit (in-person) for procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Fetoscopic Endoluminal Tracheal Occlusion
Trial Overview The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery on unborn babies with CDH. It involves placing a balloon in the airway to help lung growth by allowing fluid buildup. The safety and effectiveness of both the FETO procedure and its removal are being evaluated.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Fetuses with R- sided CDH with O/E LHR < 45%Experimental Treatment1 Intervention
Fetuses with Right CDH (O/E LHR \< 45%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Group II: Fetuses with Left CDH (O/E LHR < 25%)Experimental Treatment1 Intervention
Fetuses with Left CDH (O/E LHR \< 25%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Group III: Fetuses with L- sided CDH with O/E LHR <30%.Experimental Treatment1 Intervention
Fetuses with Left CDH (O/E LHR \< 30%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Fetoscopic Endoluminal Tracheal Occlusion is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as FETO for:
  • Severe congenital diaphragmatic hernia (CDH)
🇪🇺
Approved in European Union as FETO for:
  • Severe congenital diaphragmatic hernia (CDH)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Findings from Research

Fetal endoscopic tracheal occlusion (FETO) was performed successfully in 210 cases of congenital diaphragmatic hernia (CDH), with a high success rate of balloon placement (96.7%) and a median procedure duration of 10 minutes.
While FETO is associated with a significant risk of spontaneous preterm prelabor rupture of membranes (47.1%) and preterm delivery, it notably improves survival rates for affected fetuses, increasing survival from 24.1% to 49.1% for left-sided CDH and from 0% to 35.3% for right-sided CDH.
Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion.Jani, JC., Nicolaides, KH., Gratacós, E., et al.[2022]
In a study of 18 children with severe congenital diaphragmatic hernia (CDH) who underwent fetoscopic endoluminal tracheal occlusion (FETO), long-term survival rates were comparable to a non-FETO group, with 67% surviving at 5 years.
Despite improvements in pulmonary morbidity and gastroesophageal reflux disease, many FETO patients continued to require bronchodilators and feeding tubes, indicating ongoing health challenges even after the procedure.
Morbidity in children after fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: Results from a multidisciplinary clinic.Sferra, SR., Nies, MK., Miller, JL., et al.[2023]
In a trial involving 196 women, fetoscopic endoluminal tracheal occlusion (FETO) did not show a significant improvement in survival rates for infants with moderate congenital diaphragmatic hernia compared to expectant care, with 63% survival in the FETO group versus 50% in the control group (P=0.06).
FETO was associated with higher risks of preterm birth and prelabor rupture of membranes (44% vs. 12% and 64% vs. 22%, respectively), indicating potential safety concerns despite no serious maternal complications reported.
Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia.Deprest, JA., Benachi, A., Gratacos, E., et al.[2022]

References

Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. [2022]
Morbidity in children after fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: Results from a multidisciplinary clinic. [2023]
Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia. [2022]
Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. [2020]
Prevalence of symptomatic tracheal morbidities after fetoscopic endoluminal tracheal occlusion: a systematic review and meta-analysis. [2023]
A novel translational model of percutaneous fetoscopic endoluminal tracheal occlusion - baboons (Papio spp.). [2021]
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