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

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). ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{1 2 3 4 5}

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

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

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

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+

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.

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]

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]

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]

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]

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]

References

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

Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. [2022]

2. 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]

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

Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Prevalence of symptomatic tracheal morbidities after fetoscopic endoluminal tracheal occlusion: a systematic review and meta-analysis. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A novel translational model of percutaneous fetoscopic endoluminal tracheal occlusion - baboons (Papio spp.). [2021]