FETO Surgery for Congenital Diaphragmatic Hernia

Recruiting in Palo Alto (17 mi)

Overseen by Hanmin Lee, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Hanmin Lee

Disqualifiers: Multifetal pregnancy, Preterm labor, Placental abnormalities, Maternal HIV, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Despite advances in prenatal diagnosis and postnatal therapies, including ECMO (Extracorporeal Membrane Oxygenation), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with severe CDH remain high. The rationale for fetal therapy in severe CDH is to promote adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. The investigator's goal with this pilot study is to study the feasibility of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with left CDH (LHR O/E \< 25%).

Do I need to stop my current medications for the FETO Surgery 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 healthcare provider.

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 (CDH), although there are concerns about potential complications like tracheomegaly (enlarged windpipe) and tracheomalacia (softening of the windpipe). ^{1 2 3 4 5}

How is the FETO treatment different from other treatments for congenital diaphragmatic hernia?

FETO is a unique treatment for congenital diaphragmatic hernia 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 surgical approaches that are performed after birth. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for pregnant women over 18 with a single pregnancy and severe left CDH in the fetus, where the liver has moved into the chest. Participants must have normal fetal chromosomes, be at 27-29 weeks gestation for surgery, meet psychosocial criteria, consent to participate, and secure payment or insurance coverage.

Inclusion Criteria

I am pregnant and 18 years or older.

My unborn baby has a severe lung problem diagnosed by ultrasound.

Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound

Exclusion Criteria

Placental abnormalities (previa, abruption, accrete) known at time of enrollment

Multi-fetal pregnancy

I do not have HIV or Hepatitis B/C, or I have tested negative for these.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of balloon using the BALT GOLDBAL2 balloon and BALTACCIBDPE100 catheter

Between 27 and 29 weeks gestation

Follow-up

Participants are monitored for fetal lung growth and survival rate after FETO

6 months after birth

Treatment Details

Interventions

• Fetoscopic Endoluminal Tracheal Occlusion (Procedure)

Trial Overview The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery on fetuses with severe lung underdevelopment due to CDH. The goal is to see if blocking the trachea prenatally can improve lung growth before birth.

Participant Groups

Group I: Device - FETO Experimental Treatment 1 Intervention

Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of balloon using the BALT GOLDBAL2 balloon and BALTACCIBDPE100 catheter.

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

Research Locations Nearby Select from list below to view details:

University of California San Francisco Fetal Treatment Center San Francisco, CA

Who Is Running the Clinical Trial?

Hanmin Lee Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Prevalence of symptomatic tracheal morbidities after fetoscopic endoluminal tracheal occlusion: a systematic review and meta-analysis. [2023] Fetoscopic endoluminal tracheal occlusion (FETO) has been shown to improve survival of infants with congenital diaphragmatic hernia (CDH). However, there are concerns that FETO may lead to tracheomegaly, tracheomalacia and related complications.

2. England pubmed.ncbi.nlm.nih.gov

Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. [2022] To examine operative and perinatal aspects of fetal endoscopic tracheal occlusion (FETO) in congenital diaphragmatic hernia (CDH).

3. Australia pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. [2020] To present the feasibility, safety and outcomes of fetoscopic endoluminal tracheal occlusion (FETO) for the treatment of severe congenital diaphragmatic hernia (CDH).

4. United States pubmed.ncbi.nlm.nih.gov

Morbidity in children after fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: Results from a multidisciplinary clinic. [2023] Although fetoscopic endoluminal tracheal occlusion (FETO) was recently shown to improve survival in a multicenter, randomized trial of severe congenital diaphragmatic hernia (CDH), morbidity outcomes remain essentially unknown. The purpose of this study was to assess long-term outcomes in children with severe CDH who underwent FETO.

5. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia. [2022] Fetoscopic endoluminal tracheal occlusion (FETO) has been associated with increased postnatal survival among infants with severe pulmonary hypoplasia due to isolated congenital diaphragmatic hernia on the left side, but data are lacking to inform its effects in infants with moderate disease.