Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

(FETO Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure for treating babies diagnosed with congenital diaphragmatic hernia (CDH), a condition where a hole in the diaphragm allows organs to move into the chest, affecting lung development. The procedure, called Fetal Endoscopic Tracheal Occlusion (FETO), involves placing a small balloon in the unborn baby's trachea to aid lung growth. The trial aims to assess the safety and effectiveness of this treatment. Pregnant individuals with a single fetus diagnosed with a specific type of CDH, where the liver is pushed upwards and certain lung growth measurements are met, might be suitable candidates. As an unphased trial, this study offers the chance to contribute to groundbreaking research that could improve outcomes for future patients with CDH.

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.

What prior data suggests that the Fetal Endoscopic Tracheal Occlusion procedure is safe?

Studies have shown that the Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure is a safe option for treating severe congenital diaphragmatic hernia (CDH) in unborn babies. Research indicates that the procedure generally works well without causing significant harm.

The FETO procedure uses a special balloon device called the BALT GoldbBAL2 Detachable Balloon. Safety data from past studies suggest that the procedure is well-tolerated, with serious problems or side effects being uncommon.

Research also examines the short-term outcomes for babies after the procedure to assess its safety. These studies show that the procedure is safe to use during pregnancy, although, like any medical intervention, some risks exist. Overall, the available data supports the safety of FETO for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for congenital diaphragmatic hernia, which often involve postnatal surgery and intensive care, fetal endoscopic tracheal occlusion (FETO) offers a prenatal intervention. This procedure uses the BALT GoldbBAL2 Detachable Balloon, which is inserted endoscopically, to temporarily block the fetus's trachea. This innovative approach encourages lung growth before birth, potentially improving survival rates and reducing complications after delivery. Researchers are excited because FETO directly addresses the underlying lung development issues, offering hope for better outcomes than current postnatal treatment options.

What evidence suggests that this procedure is effective for congenital diaphragmatic hernia?

Research has shown that Fetoscopic Endoluminal Tracheal Occlusion (FETO), which participants in this trial will undergo, can be a promising treatment for babies with severe congenital diaphragmatic hernia (CDH). Studies have found that FETO significantly improves survival chances for these infants. Specifically, the TOTAL trials discovered that this procedure aids lung growth before birth, crucial for survival. Additionally, evidence suggests that FETO is a good option for severe CDH cases, with positive outcomes reported. Overall, FETO has the potential to be a life-saving treatment for unborn babies diagnosed with this condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Rodrigo Ruano, MD, Ph.D

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

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 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]

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]

Citations

1. 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.

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8192998/

Fetal endoscopic tracheal occlusion for congenital ... Fetal intervention for fetuses with congenital diaphragmatic hernia (CDH) has been investigated for over 30 years and is summarized in this manuscript.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04583644?term=AREA%5BConditionSearch%5D(FETO%20CDH)&rank=5

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion ... The investigator's goal with this pilot study is to study the feasibility of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03138863

Study Details | NCT03138863 | Fetal Endoscopic Tracheal ... The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa035005

A Randomized Trial of Fetal Endoscopic Tracheal ... Experimental and clinical data suggest that fetal endoscopic tracheal occlusion to induce lung growth may improve the outcome of severe congenital ...