FETO for Diaphragmatic Hernia

(FETO Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Aimen Shaaban, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Aimen F. Shaaban, MD

Disqualifiers: Chromosomal abnormalities, Preterm labor, Placental abnormalities, Maternal HIV, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Research Team

Aimen Shaaban, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

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

I am pregnant and 18 years or older.

Provision of signed and dated informed consent form

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

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

Group I: FETO with GOLDBAL2 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Aimen F. Shaaban, MD

Lead Sponsor

Trials

1

Recruited

10+

Findings from Research

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]

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]

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]

References

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]