Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Overseen By Rodrigo Ruano, MD, Ph.D

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Rodrigo Ruano

Disqualifiers: Multi-fetal pregnancy, Preterm labor, Placenta previa, 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 examines a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) to determine its safety and effectiveness in treating Congenital Diaphragmatic Hernia (CDH). CDH occurs when a baby's diaphragm doesn't form properly, affecting lung development. The treatment uses a special balloon, the BALT GoldbBAL2 Detachable Balloon, to block the trachea (windpipe) in the fetus, promoting lung growth. Expectant mothers carrying a single baby diagnosed with severe left-sided CDH and meeting specific lung development criteria may qualify. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve outcomes for future CDH patients.

Will I have to stop taking my current medications?

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 Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure is safe?

Research shows that the Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure is generally well-tolerated. This procedure uses a special balloon and catheter system to assist babies with congenital diaphragmatic hernia, a severe birth defect where a hole in the diaphragm allows organs to move into the chest. During FETO, a balloon is placed in the unborn baby's airway to aid lung development.

Studies suggest that babies undergoing this procedure often experience good outcomes. While researchers continue to collect safety data, FETO has been used in several studies without major safety concerns. Like any medical procedure, there are risks, but current research supports its potential benefits in severe cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fetal endoscopic tracheal occlusion (FETO) is unique because it offers a targeted approach to treating congenital diaphragmatic hernia (CDH) by directly promoting lung growth before birth. Unlike traditional postnatal surgeries, FETO involves inserting a detachable balloon into the fetus's trachea to temporarily block it, encouraging the lungs to expand while still in the womb. This method aims to improve lung development and function at an earlier stage, potentially leading to better outcomes for infants born with CDH. Researchers are excited about FETO because it represents a proactive prenatal intervention that could significantly enhance survival rates and quality of life for affected babies.

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

This trial will evaluate Fetoscopic Endoluminal Tracheal Occlusion (FETO) as a treatment for babies with severe congenital diaphragmatic hernia (CDH). CDH occurs when a hole in the diaphragm allows organs to move into the chest, affecting lung development. Participants in this trial will undergo FETO surgery using the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system. Research indicates that temporarily blocking the windpipe with a balloon helps the lungs grow better. Evidence suggests that FETO can improve outcomes for these babies. Although researchers are still studying the procedure's safety and effectiveness, early findings are encouraging for its use in severe CDH cases. ^{2 3 4 5 6}

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 chromosomal abnormalities. The fetus must have a specific lung-to-head ratio indicating pulmonary hypoplasia, and the gestational age should be between 27 to just under 32 weeks at the time of surgery.

Inclusion Criteria

My condition involves the left side of my diaphragm being affected with my liver positioned higher.

My baby's genetic test results are normal.

You are pregnant with only one baby.

Exclusion Criteria

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

My unborn baby has been diagnosed with additional anomalies or chromosomal abnormalities.

My baby has a right-sided or bilateral diaphragmatic hernia, or an isolated left-sided one with specific ultrasound measurements.

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 gestational age at delivery and maternal complications

Up to 41 weeks gestation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including infant diaphragmatic repair, ECMO support, and other neonatal outcomes

Up to 24 months post partum

What Are the Treatments Tested in This Trial?

Interventions

• BALT GoldbBAL2 Detachable Balloon
• Catheter System

Trial Overview The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO), using BALT GoldbBAL2 Detachable Balloon and Catheter System. This procedure aims to improve lung development in fetuses with CDH by temporarily blocking their trachea.

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

Lead Sponsor

Trials

5

Recruited

40+

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]

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 endoscopic tracheal occlusion (FETO) was performed successfully in 210 cases of congenital diaphragmatic hernia (CDH), with a high success rate of balloon placement (96.7%) and a median procedure duration of 10 minutes.

While FETO is associated with a significant risk of spontaneous preterm prelabor rupture of membranes (47.1%) and preterm delivery, it notably improves survival rates for affected fetuses, increasing survival from 24.1% to 49.1% for left-sided CDH and from 0% to 35.3% for right-sided CDH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Jani, JC., Nicolaides, KH., Gratacós, E., et al.[2022]

Fetal endoscopic tracheal occlusion (FETO) using a 1.0-mm fetoscope was successfully performed in 16 fetuses with severe congenital diaphragmatic hernia (CDH), leading to a significant increase in neonatal survival rates (52.9% in the FETO group vs. 5.6% in the control group).

The study also found that FETO reduced the incidence of severe pulmonary arterial hypertension in infants, with 47.1% of the FETO group affected compared to 88.9% in the control group, indicating a potential improvement in neonatal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between fetal endoscopic tracheal occlusion using a 1.0-mm fetoscope and prenatal expectant management in severe congenital diaphragmatic hernia. Ruano, R., Duarte, SA., Pimenta, EJ., et al.[2016]

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]

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]

Endoscopic tracheal occlusion (TO) in fetal lambs with congenital diaphragmatic hernia (CDH) successfully increased lung growth, with 5 out of 11 procedures resulting in live births and expanded lungs.

The TO group showed significantly greater lung weight compared to those without TO, suggesting that this minimally invasive technique could be a promising alternative to open fetal surgery for improving outcomes in CDH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tracheal obstruction in experimental diaphragmatic hernia: an endoscopic approach in the fetal lamb. Benachi, A., Dommergues, M., Delezoide, AL., et al.[2014]

Citations

1. 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 ...

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

Fetal endoscopic tracheal occlusion for congenital ... The current procedure utilizes a fetoscopic approach with a detachable balloon that is placed midgestation and removed around 34 weeks (see Figure 1) (41,52,53) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04052828?term=AREA%5BConditionSearch%5D(FETO%20CDH)&rank=7

Fetal Endoscopic Tracheal Occlusion (FETO) Trial for ... This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon ...

4. 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.

5. stanfordhealthcare.org stanfordhealthcare.org/trials/f/NCT05461222.html

Fetal Endoscopic Tracheal Occlusion (FETO) for Severe ... The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This ...

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

Fetal Endotracheal Occlusion (FETO) in Fetuses with ... The Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus using the Delivery Microcatheter (BALTACCI-BDPE100). The fetal ...