FETO Surgery for Congenital Diaphragmatic Hernia

Overseen By Katie Archbold, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hanmin Lee

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Between 27 and 29 weeks gestation

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new prenatal surgery called Fetoscopic Endoluminal Tracheal Occlusion (FETO) to assist babies with congenital diaphragmatic hernia (CDH), a severe condition affecting lung development. This treatment might promote better lung growth before birth, potentially improving survival rates. Pregnant women carrying a single fetus with severe left CDH, confirmed by specific ultrasound measures, may qualify to participate. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance prenatal care for future patients.

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 prior data suggests that this device is safe for FETO surgery?

Research has shown that Fetoscopic Endoluminal Tracheal Occlusion (FETO) is a promising treatment for severe congenital diaphragmatic hernia (CDH) in unborn babies. Studies have found that FETO can improve survival rates and promote better lung growth.

Some studies have noted that while FETO can increase survival and reduce lung issues, it might also cause the trachea (windpipe) to enlarge, a condition known as tracheomegaly. However, overall results suggest that FETO is a safe and effective treatment option for severe CDH cases.

These findings indicate that FETO is generally well-tolerated, but like any medical procedure, it carries potential risks. Prospective trial participants should discuss these risks with their healthcare provider to make an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery is unique because it offers a new approach to treating congenital diaphragmatic hernia by temporarily blocking the fetal trachea with a balloon. This procedure aims to promote lung growth by trapping fluid inside the lungs, which can be particularly beneficial in severe cases where traditional surgical repairs might fall short. Researchers are excited about FETO because it targets the problem at its developmental stage, potentially improving lung function and survival rates before birth, unlike standard postnatal surgical interventions.

What evidence suggests that FETO surgery is effective for congenital diaphragmatic hernia?

Research has shown that Fetoscopic Endoluminal Tracheal Occlusion (FETO), which participants in this trial will receive, can help babies with severe congenital diaphragmatic hernia (CDH). One study found that FETO nearly doubled the survival rate from 24% to 49% for babies with isolated left CDH. This treatment involves temporarily blocking the fetus's windpipe, promoting better lung growth before birth. FETO has been successfully performed in most cases, suggesting it is a promising option for improving outcomes in severe CDH. The increased lung growth from this procedure is crucial for helping babies survive after birth. ^{1 4 6 7 8}

Who Is on the Research Team?

Hanmin Lee, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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

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

My condition involves the left side of my diaphragm being affected with my liver positioned higher than normal.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Fetoscopic Endoluminal Tracheal Occlusion

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.

How Is the Trial Designed?

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)

Who Is Running the Clinical Trial?

Hanmin Lee

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

A systematic review of 10 studies involving 449 infants who underwent fetoscopic endoluminal tracheal occlusion (FETO) for congenital diaphragmatic hernia (CDH) found that 6% of infants born alive and 12% of those who survived to discharge experienced symptomatic tracheal complications.

These complications ranged from mild symptoms like barking cough to severe issues requiring tracheostomy, highlighting the need for ongoing monitoring of FETO survivors and the development of devices that reduce tracheal injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of symptomatic tracheal morbidities after fetoscopic endoluminal tracheal occlusion: a systematic review and meta-analysis. Tho, ALW., Rath, CP., Tan, JKG., et al.[2023]

Fetoscopic endoluminal tracheal occlusion (FETO) is a feasible and safe procedure for treating severe congenital diaphragmatic hernia (CDH), with successful balloon insertion in all 11 cases studied, and no severe maternal adverse events reported.

The procedure resulted in a 45% survival rate at 90 days of age and at discharge for the treated fetuses, indicating its potential effectiveness in promoting fetal lung growth in cases of isolated left-sided CDH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. Wada, S., Ozawa, K., Sugibayashi, R., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia. Deprest, JA., Benachi, A., Gratacos, E., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11627046/

Feasibility, safety, and outcome of fetoscopic endoluminal ... Our data have shown that FETO represents a viable option for severe type of CDH fetuses with reasonable outcome.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02530073

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) ... Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%. The goal of ...

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/pd.6803

Fetal Endoscopic Tracheal Occlusion (FETO) for Left and ... FETO was successfully performed in 47/48 (98%) cases at an average gestational age (GA) of 28.5 (24–31.6) weeks including 22 (47%) moderate LCDH ...

4. childrenscolorado.org childrenscolorado.org/advances-answers/recent-articles/fetoscopic-endoluminal-tracheal-occlusion/

FETO for Congenital Diaphragmatic Hernia In a sub-analysis comparing patients with severe cases, 63 underwent FETO and 43 were managed expectantly. Although survival was similar for ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35838786/

Fetal endoscopic tracheal occlusion for moderate and ... Conclusion: FETO increases the survival rate in fetuses with moderate and severe CDH, especially in fetuses with severe CDH. However, FETO is ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06946576

Safety and Efficacy of Fetoscopic Endoluminal Tracheal ... The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7756773/

Feasibility and outcomes of fetoscopic endoluminal ... Aim. To present the feasibility, safety and outcomes of fetoscopic endoluminal tracheal occlusion (FETO) for the treatment of severe congenital ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480424006917

Neonatal Airway Management and Outcomes Following ... Fetoscopic endoluminal tracheal occlusion (FETO) has been shown to improve survival and pulmonary hypertension, however, is associated with tracheomegaly.