Fetoscopic Surgery for Congenital Diaphragmatic Hernia

(FETO Trial)

Overseen By Elizabeth Torres

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Maternal contraindication, Preterm labor, 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: 2

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgical technique called Fetoscopic Endoluminal Tracheal Occlusion (FETO) to assist unborn babies with Congenital Diaphragmatic Hernia (CDH). In CDH, a hole in the diaphragm allows organs to move into the chest, restricting lung growth. The surgery involves using a small balloon device to block the baby's airway, enabling fluid buildup to help the lungs grow larger, potentially improving the baby's quality of life. Pregnant women carrying a single baby diagnosed with severe CDH, where the liver is displaced upward, may qualify if they meet certain criteria. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could significantly enhance treatment options for CDH.

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 prior data suggests that the FETO device is safe for fetuses with Congenital Diaphragmatic Hernia?

Research shows that Fetoscopic Endoluminal Tracheal Occlusion (FETO) offers promise as a treatment for severe Congenital Diaphragmatic Hernia (CDH) in unborn babies. Studies indicate that FETO is generally well-tolerated and leads to good outcomes. Specifically, data from the TOTAL trials demonstrated significant improvements in survival rates after this procedure. Among 4,524 patients with CDH, those who underwent FETO experienced positive results, including lung growth, which is essential for development and quality of life.

While any medical procedure carries some risk, current research suggests that FETO is a safe option for babies with CDH when performed by experienced medical teams. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Fetoscopic Endoluminal Tracheal Occlusion (FETO) for treating congenital diaphragmatic hernia (CDH) because it offers a targeted, minimally invasive approach. Unlike traditional treatments that often involve post-birth surgical repair, FETO is performed before birth using a tiny fetoscope to temporarily block the fetus's trachea. This unique method encourages lung growth and development in the womb, potentially improving survival rates and reducing complications associated with CDH. By intervening early in fetal development, FETO aims to address the root of the problem rather than just managing symptoms after birth.

What evidence suggests that the FETO surgery is effective for treating Congenital Diaphragmatic Hernia?

Research has shown that a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) may help treat severe Congenital Diaphragmatic Hernia (CDH) in unborn babies. In this trial, fetuses with varying severities and sides of CDH will receive FETO. Studies have found that FETO can significantly improve survival rates by promoting lung growth in the baby. Specifically, the TOTAL trials demonstrated that babies who underwent FETO had better survival chances than those who did not. Another study found FETO to be a practical option for severe CDH cases. The procedure involves temporarily blocking the airway with a balloon, aiding proper lung development. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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

Exclusion Criteria

Rubber latex allergy

I am pregnant and under 18.

I have a health condition that prevents me from having surgery during pregnancy.

Timeline for a Trial Participant

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

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 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.

How Is the Trial Designed?

Group I: Fetuses with R- sided CDH with O/E LHR < 45% Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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)

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

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]

The study successfully established a percutaneous fetoscopic endoluminal reversible tracheal occlusion (FETO) model in non-human primates, which is crucial for improving fetal outcomes in cases of congenital diaphragmatic herniation.

The FETO procedure did not result in any complications such as bleeding or premature fetal membrane rupture, and it led to a significant increase in tracheal width in the treated group compared to controls, indicating its potential efficacy in mimicking human conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel translational model of percutaneous fetoscopic endoluminal tracheal occlusion - baboons (Papio spp.). Mari, G., Deprest, J., Schenone, M., et al.[2021]

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]

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]

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/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 ...

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

Fetal Endoscopic Tracheal Occlusion (FETO) for Left and ... Data from the TOTAL (tracheal occlusion to accelerate lung growth) trials have demonstrated significant improvement in survival following fetal ...

4. mdpi.com mdpi.com/1422-0067/26/4/1639

Fetoscopic Endoluminal Tracheal Occlusion-Synergic ... Introduction. Congenital diaphragmatic hernia (CDH) is a relatively rare developmental condition that occurs in about 1 out of every 2500 live births [1].

5. karger.com karger.com/fdt/article/doi/10.1159/000546839/929109/Fetoscopic-Endoluminal-Tracheal-Occlusion-in

Fetoscopic Endoluminal Tracheal Occlusion in Congenital ... The primary outcome was survival, correlated with lung growth and prematurity. Results: Among 4,524 CDH patients, 106 (2.3%) received FETO; ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10863657/

Fetoscopic Endoluminal Tracheal Occlusion for Severe, Left ... In this study, we 1) report procedural outcomes in a North American cohort of patients with prenatally diagnosed left-sided congenital ...