Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

(FETO Trial)

Recruiting at 1 trial location

Overseen By Rodrigo A Ruano, MD, Ph.D

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Rodrigo Ruano M.D., Ph.D

Disqualifiers: Multi-fetal pregnancy, Latex allergy, Preterm labor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).

Do I need to stop my current medications for this 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.

Is the use of detachable balloons in medical procedures generally safe?

Research indicates that detachable balloons have been used safely in various medical procedures, such as occluding coronary artery fistulas in children and atrial septal defects in piglets, with no significant adverse reactions reported during follow-up periods. ^{1 2 3 4 5}

How does the Fetal Endoscopic Tracheal Occlusion treatment differ from other treatments for congenital diaphragmatic hernia?

The Fetal Endoscopic Tracheal Occlusion (FETO) treatment is unique because it involves placing a detachable balloon in the fetus's trachea to promote lung growth before birth, which is different from traditional surgical approaches that are performed after birth. This prenatal intervention aims to improve lung development in cases of congenital diaphragmatic hernia, offering a novel approach compared to postnatal surgical repairs. ^{6 7 8 9 10}

Research Team

Rodrigo Ruano, MD, Ph.D

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for pregnant individuals with a single fetus diagnosed with severe left-sided Congenital Diaphragmatic Hernia (CDH) and liver up, without other fetal anomalies or maternal health risks. The gestational age must be between 27 weeks and 31 weeks 6 days at the time of the FETO procedure, depending on specific lung-to-head ratio measurements.

Inclusion Criteria

My baby's genetic test results are normal.

You are pregnant with only one baby.

If the baby's lung size is less than 25% of what is expected at 27 to 29 weeks of pregnancy, or between 25% and 30% of what is expected at 30 to 31 weeks of pregnancy, based on the mother's last menstrual period and the first ultrasound, they will not be included.

Exclusion Criteria

I do not have HIV, Hepatitis-B, or Hepatitis-C.

I am at risk of early labor due to a short cervix or uterine issues.

I do not have someone to stay with me during my pregnancy at the hospital.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

FETO Procedure

Participants undergo fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system

Up to 34 weeks gestation

Delivery and Immediate Postpartum

Monitoring of maternal and fetal outcomes, including gestational age at delivery and maternal complications

Up to 41 weeks gestation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pulmonary hypertension, oxygen dependency, and other infant health outcomes

Up to 24 months post partum

Treatment Details

Interventions

• BALT GoldbBAL2 Detachable Balloon
• Catheter System
• Fetal Endoscopic Tracheal Occlusion

Trial Overview The trial tests the safety and effectiveness of Fetoscopic Endoluminal Tracheal Occlusion (FETO), using BALT GoldbBAL2 Detachable Balloon and Catheter System to treat CDH in fetuses by occluding the trachea to promote lung growth.

Participant Groups

Group I: FETO Group Experimental Treatment 2 Interventions

Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.

BALT GoldbBAL2 Detachable Balloon is already approved in European Union for the following indications:

Approved in European Union as BALT GoldbBAL2 Detachable Balloon for:

• Congenital Diaphragmatic Hernia

Who Is Running the Clinical Trial?

Rodrigo Ruano M.D., Ph.D

Lead Sponsor

Trials

2

Recruited

20+

Rodrigo Ruano

Lead Sponsor

Trials

5

Recruited

40+

Findings from Research

The exchangeable atrial balloon device is designed to be implanted in the atrial appendage, providing a novel approach for potential cardiac interventions.

This device utilizes a combination of an outer guide and a latex Foley catheter, which may offer advantages in terms of accessibility and functionality during procedures involving the heart.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exchangable intra-atrial balloon device. Chapman, LW., Mittmann, UM.[2017]

The Debrun system for transcatheter coronary artery fistula occlusion was successfully used in three pediatric patients, demonstrating controlled delivery and the ability to perform 'test occlusions' for better monitoring during the procedure.

After up to 3 years of follow-up, no adverse reactions were observed, indicating that this method is a safe and effective alternative to surgical ligation for treating coronary artery fistulas in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous transcatheter occlusion of coronary artery fistulas using detachable balloons. Skimming, JW., Gessner, IH., Victorica, BE., et al.[2018]

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]

The Trans-Urethral Catheterisation Safety Valve effectively prevents urethral trauma during catheterization in male spinal cord injury patients by stopping balloon inflation if the catheter is incorrectly positioned, as demonstrated in 44 catheterizations.

While the safety-valve is generally effective, it is important for health professionals to follow proper procedures, such as pre-valve inflation, to avoid issues like leakage and ensure the catheter is correctly placed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible Use of a Safety-Valve with a Foley Catheter During Catheterisation of Male Spinal Cord Injury Patients for Prevention of Urethral Trauma Caused by Inflation of the Catheter Balloon in the Urethra. Subramanian, V., Soni, BM.[2023]

Fetal urethroplasty using a balloon catheter was performed on 10 male fetuses with lower urinary tract obstruction, showing a 100% survival rate and no complications during the procedure, indicating its safety.

The procedure successfully restored micturition in 50% of the cases, allowing for normal urine output in neonates, although some showed signs of renal insufficiency, highlighting the potential benefits and risks of this new prenatal treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urethroplasty with balloon catheterization in fetal lower urinary tract obstruction: observational study of 10 fetuses. Dębska, M., Koleśnik, A., Kretowicz, P., et al.[2021]

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]

Transcatheter occlusion of congenital coronary arterial fistulas in adults is a safe and effective procedure, as demonstrated in a study of 5 symptomatic patients aged 47 to 70, all of whom had successful occlusions without complications.

The use of detachable balloons and coils for occlusion resulted in complete closure of the fistulas, with follow-up angiography showing no signs of recanalization, suggesting long-term efficacy of this minimally invasive approach compared to traditional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter embolization of congenital coronary arterial fistulas in adults. Kambara, AM., Pedra, CA., Esteves, CA., et al.[2019]

The Gianturco-Grifka Vascular Occlusion Device (GGVOD) was developed for transcatheter occlusion of congenital heart defects, specifically the patent ductus arteriosus (PDA), and has shown complete occlusion in both canine models and pediatric patients without complications.

This device offers significant advantages over existing options, including the ability to reposition or remove it before release, adaptability to various vascular shapes, and availability in four different sizes, making it a versatile tool for treating vascular anomalies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter PDA Closure Using the Gianturco-Grifka Vascular Occlusion Device. Grifka, RG.[2020]

A premature neonate with a rare combination of left congenital diaphragmatic hernia (CDH), esophageal atresia (EA), and distal tracheoesophageal fistula (TEF) survived past 6 years, highlighting the potential for successful management of this lethal condition.

The surgical approach included temporary banding of the gastroesophageal junction and staged repairs, with extracorporeal membrane oxygenation (ECMO) support, demonstrating that careful surgical management can improve outcomes in complex cases like this.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coexisting left congenital diaphragmatic hernia and esophageal atresia with tracheoesophageal fistula: successful management in a premature neonate. Sapin, E., Berg, A., Raynaud, P., et al.[2019]

In a clinical trial involving 35 patients aged 0.5 to 27.2 years, the DuctOcclud device successfully occluded the patent ductus arteriosus (PDA) in 91% of cases, demonstrating its efficacy.

After 6 months, 84% of the patients had no residual shunt, indicating successful closure, and the procedure was deemed safe with no serious complications, aside from one case of infective endocarditis that was fully resolved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter occlusion of patent ductus arteriosus with a new detachable coil system (DuctOcclud): a multicenter clinical trial. Oho, S., Ishizawa, A., Koike, K., et al.[2019]

References

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

An exchangable intra-atrial balloon device. [2017]

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

Percutaneous transcatheter occlusion of coronary artery fistulas using detachable balloons. [2018]

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

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

4. New Zealand pubmed.ncbi.nlm.nih.gov

Possible Use of a Safety-Valve with a Foley Catheter During Catheterisation of Male Spinal Cord Injury Patients for Prevention of Urethral Trauma Caused by Inflation of the Catheter Balloon in the Urethra. [2023]

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

Urethroplasty with balloon catheterization in fetal lower urinary tract obstruction: observational study of 10 fetuses. [2021]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Transcatheter embolization of congenital coronary arterial fistulas in adults. [2019]

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

Transcatheter PDA Closure Using the Gianturco-Grifka Vascular Occlusion Device. [2020]

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

Coexisting left congenital diaphragmatic hernia and esophageal atresia with tracheoesophageal fistula: successful management in a premature neonate. [2019]

10. Japan pubmed.ncbi.nlm.nih.gov

Transcatheter occlusion of patent ductus arteriosus with a new detachable coil system (DuctOcclud): a multicenter clinical trial. [2019]