FETO for Diaphragmatic Hernia

(FETO Trial)

Overseen By Aimen Shaaban, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Aimen F. Shaaban, MD

Disqualifiers: Chromosomal abnormalities, 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: 2

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the feasibility of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) to assist unborn babies with congenital diaphragmatic hernia (CDH). The procedure places a small detachable balloon in the baby's airway to enhance lung growth before birth, potentially improving survival after birth. This study targets pregnant women carrying a single baby diagnosed with severe CDH and no other major health issues. Participants must live near the Chicago Institute for Fetal Health during the study and have a support person available. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve outcomes for future families facing similar challenges.

Do I have to stop taking my current medications for the FETO 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 team or your doctor.

What prior data suggests that the FETO procedure is safe for fetuses with congenital diaphragmatic hernia?

Research shows that the FETO (Fetoscopic Endoluminal Tracheal Occlusion) procedure has been studied for its safety and effectiveness in treating severe congenital diaphragmatic hernia (CDH). Studies have found that FETO can help fetal lungs develop better and may increase survival rates for babies after birth.

Previous research, including data from the TOTAL trials, showed significant improvements in survival for fetuses with severe CDH who underwent FETO. The procedure involves temporarily blocking the baby's windpipe to aid lung growth.

No major safety concerns have been reported with this procedure. Studies suggest it is generally well-tolerated. However, like any medical procedure, there may be risks and potential complications, which should be discussed with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about FETO with the Goldballoon Detachable Balloon (GOLDBAL2) for treating diaphragmatic hernia because it introduces a novel approach by temporarily blocking the fetal airway, promoting lung growth before birth. Unlike traditional surgical methods used after birth, this technique is performed in utero, potentially improving lung development and outcomes for affected babies. The use of the detachable balloon allows for a less invasive procedure, offering hope for better survival rates and reduced complications compared to current postnatal interventions.

What evidence suggests that FETO is effective for diaphragmatic hernia?

Research has shown that Fetoscopic Endoluminal Tracheal Occlusion (FETO) might help treat severe congenital diaphragmatic hernia (CDH) in unborn babies. In this trial, participants will undergo the FETO procedure using the Goldballoon Detachable Balloon (GOLDBAL2). Studies have found that FETO can increase survival chances for babies with CDH. The procedure involves placing a small balloon in the baby's airway to block it, which aids lung growth. Data from earlier trials showed that FETO significantly improved survival rates. This suggests that FETO could effectively help babies with severe CDH by increasing lung size and improving health outcomes. ^{1 3 5 6 7}

Who Is on the Research Team?

Aimen Shaaban, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 with a single pregnancy and severe congenital diaphragmatic hernia in the fetus, showing specific lung underdevelopment. Participants must be willing to follow study procedures, live near the Chicago Institute for Fetal Health, and have no major health issues or conditions that could affect safety or compliance.

Inclusion Criteria

Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects

Provision of signed and dated informed consent form

Subject has a support person (e.g., spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near Lurie Children's

Exclusion Criteria

It's not safe or possible to place a balloon in my womb using a scope.

Rubber latex allergy

Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

FETO Procedure

Insertion of the Goldballoon Detachable Balloon into the fetal trachea between 27 weeks 0 days and 29 weeks 6 days of gestation

2 weeks

1 visit (in-person)

Balloon Monitoring

Weekly monitoring of fetal lung growth and health status while the balloon is in place

5-7 weeks

Weekly visits (in-person)

Balloon Removal

Removal of the fetal tracheal balloon ideally at 34 weeks gestation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including infant health status until two years of age

24 months

What Are the Treatments Tested in This Trial?

Interventions

• FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)

Trial Overview The trial tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) using a detachable balloon and microcatheter on fetuses with severe diaphragmatic hernia. It aims to increase fetal lung volume before birth at Lurie Children's Hospital of Chicago.

How Is the Trial Designed?

Group I: FETO with GOLDBAL2 Experimental Treatment 1 Intervention

A detachable balloon will be inserted in the fetal airway during the FETO procedure.

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) 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?

Aimen F. Shaaban, MD

Lead Sponsor

Trials

1

Recruited

10+

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]

Percutaneous Fetal Endoscopic Tracheal Occlusion (FETO) is a safe and feasible procedure that can improve neonatal survival rates in cases of isolated congenital diaphragmatic hernia by promoting lung growth.

Key factors influencing outcomes after FETO include gestational age at birth, pre-existing lung size, and the ability to remove the balloon before delivery, with preterm premature rupture of membranes being the most common complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia and the set up of the randomized controlled TOTAL trial. Dekoninck, P., Gratacos, E., Van Mieghem, T., et al.[2016]

The Amplatzer Duct Occluder II (ADO II) was successfully implanted in all 10 patients with patent ductus arteriosus (PDA), achieving complete closure in 100% of cases, demonstrating its efficacy for this procedure.

No complications or device embolization occurred during the implantation, indicating a favorable safety profile for the ADO II in patients with PDA, particularly in smaller children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with the new Amplatzer Duct Occluder II. Dua, J., Chessa, M., Piazza, L., et al.[2016]

In a study of 51 patients, the transcatheter closure of patent ductus arteriosus (PDA) using the Amplatzer Duct Occluder II (ADO-II) was found to be safe and effective, with 49 patients achieving successful closure without significant complications during short-term follow-up.

While most patients had positive outcomes, two cases experienced device dislodgment leading to arterial obstructions, which were successfully resolved with further interventions, highlighting the importance of monitoring for potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcatheter closure of patent ductus arteriosus with the new Amplatzer Duct OccluderII]. Ji, W., Li, F., Gao, W., et al.[2016]

The detachable balloon device was successfully used to fully occlude experimental atrial septal defects (ASDs) in 20 piglets, demonstrating its efficacy in this application.

The device was found to be safe, with only one instance of embolization, and it became covered by tissue within 3 to 4 weeks, indicating good integration with the heart tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter atrial septal defect occlusion in piglets by balloon detachable devices. Sideris, EB., Kaneva, A., Sideris, SE., et al.[2019]

In a study involving 24 medical students, those trained through in-person lectures were significantly faster at setting up instruments for balloon removal in fetal endoluminal tracheal occlusion (FETO) compared to those trained via online video (62 seconds vs 81 seconds).

However, both training methods showed no significant difference in the time taken to locate and intubate the balloon in the trachea, indicating that while in-person training may enhance setup speed, both methods are equally effective for the critical task of balloon removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation training for urgent postnatal fetal tracheal balloon removal: Two learning methods. Lehoczky, L., Corroenne, R., Espinoza, J., et al.[2023]

Fetal endoscopic tracheal occlusion (FETO) is a promising intervention for isolated congenital diaphragmatic hernia that can promote lung growth in fetuses at high risk of postnatal death, with demonstrated feasibility and safety in several fetal surgery programs.

While FETO shows an apparent increase in survival rates compared to controls, the most common complication is preterm premature rupture of membranes, which may complicate the procedure and delivery, highlighting the need for further formal trials to evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical aspects of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia. Deprest, J., Nicolaides, K., Done', E., et al.[2016]

A three-month-old boy with pulmonary atresia underwent a modified Blalock-Taussig shunt, which unfortunately led to congestive heart failure.

To address this complication, a detachable balloon was successfully used to occlude the shunt, providing a less invasive alternative to surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Blalock Taussig shunt anastomosis in a three month old child with pulmonary stenosis: embolization therapy. Dubois, J., Cohen, L., Brunelle, F., et al.[2019]

In a study involving 25 patients aged 0.1 to 5 years, the Amplatzer duct occluder (ADO II) achieved a 96% success rate in completely closing patent ductus arteriosus (PDA) within one month after the procedure.

While there was a mild left pulmonary stenosis observed in 2 patients immediately after the procedure, no other complications were reported, suggesting that the ADO II is a safe and effective option for PDA closure in infants and small children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter closure of the patent ductus arteriosus using the new Amplatzer duct occluder: initial clinical applications in children. Thanopoulos, B., Eleftherakis, N., Tzannos, K., et al.[2012]

Fetal endoscopic tracheal occlusion (FETO) is a treatment for severe congenital diaphragmatic hernia that can lead to complications such as tracheomegaly in infants, as observed in a series of five cases.

This study highlights a new potential risk associated with FETO, suggesting that the compliant fetal airway may be damaged by balloon occlusion, warranting careful evaluation of the trachea in infants who underwent this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tracheomegaly: a complication of fetal endoscopic tracheal occlusion in the treatment of congenital diaphragmatic hernia. McHugh, K., Afaq, A., Broderick, N., et al.[2021]

Citations

1. 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 ...

2. 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; ...

3. 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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06281717?cond=(DIAPHRAGMATIC%20HERNIA)%20OR%20(ZFPM2)&rank=9

Fetal Endotracheal Occlusion (FETO) in Fetuses with ... The goal of this study is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with isolated severe congenital ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2027030

Randomized Trial of Fetal Surgery for Severe Left ... Previous studies have suggested that FETO improves survival among infants with congenital diaphragmatic hernia. Two small, single-center, ...

6. hopkinsmedicine.org hopkinsmedicine.org/gynecology-obstetrics/specialty-areas/fetal-therapy/fetal-interventions-procedures/fetoscopic-tracheal-occlusion

Fetoscopic Endotracheal Occlusion (FETO) Preliminary research has shown that this temporary tracheal occlusion can improve development of the fetal lung. This may lead to improved survival in babies ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38926929/

Congenital diaphragmatic hernia treated via fetal ... Conclusions: FETO may increase neonatal survival in fetuses with severe CDH, particularly in countries with limited neonatal intensive care.