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 involves placing a small balloon in the unborn baby's windpipe to help their lungs grow. It targets pregnant women whose babies have a severe condition affecting their diaphragm. The balloon helps the baby's lungs develop by blocking the windpipe.

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.

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

FETO (Fetoscopic Endoluminal Tracheal Occlusion) is unique because it involves temporarily blocking the fetal trachea with a balloon to promote lung growth, which is not done in other treatments for congenital diaphragmatic hernia. This approach is designed to improve lung development before birth, potentially increasing survival rates, but it can lead to complications like preterm delivery. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment FETO with Goldballoon Detachable Balloon (GOLDBAL2) for Diaphragmatic Hernia?

Research on detachable balloon devices, like those used in the FETO treatment, shows they have been effective and safe in closing heart defects in piglets, suggesting potential for similar success in other applications. ^{6 7 8 9 10}

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

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]

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]

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]

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 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 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]

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]

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]

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]

Citations

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

Initial experience with the new Amplatzer Duct Occluder II. [2016]

2. China pubmed.ncbi.nlm.nih.gov

[Transcatheter closure of patent ductus arteriosus with the new Amplatzer Duct OccluderII]. [2016]

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

Transcatheter closure of the patent ductus arteriosus using the new Amplatzer duct occluder: initial clinical applications in children. [2012]

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

Transcatheter atrial septal defect occlusion in piglets by balloon detachable devices. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Modified Blalock Taussig shunt anastomosis in a three month old child with pulmonary stenosis: embolization therapy. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Simulation training for urgent postnatal fetal tracheal balloon removal: Two learning methods. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Tracheomegaly: a complication of fetal endoscopic tracheal occlusion in the treatment of congenital diaphragmatic hernia. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

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

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

Technical aspects of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia. [2016]

10. Ireland 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. [2016]