What side effects are associated with this type of intervention?

Fetal Endoscopic Tracheal Occlusion (FETO) for severe congenital diaphragmatic hernia (CDH) is a procedure that involves placing a balloon in the fetal trachea to stimulate lung growth. Known side effects of FETO include preterm premature rupture of membranes (PPROM), preterm birth, and potential complications related to the balloon placement and removal, such as tracheal injury or occlusion failure. Additionally, there are risks associated with the surgical procedure itself, including infection and bleeding. These side effects highlight the need for careful monitoring and management in specialized medical centers.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments that directly mirror the Fetal Endoscopic Tracheal Occlusion (FETO) procedure for Congenital Diaphragmatic Hernia (CDH). FETO is an innovative approach aimed at promoting lung growth by occluding the fetal trachea, and it is currently being studied for its efficacy and safety. Traditional management of CDH often involves postnatal surgical repair and supportive care, but FETO represents a novel prenatal intervention that is still under investigation.

What other types of research exist?

As of 2024, promising novel alternatives to Fetal Endoscopic Tracheal Occlusion (FETO) for treating severe congenital diaphragmatic hernia (CDH) include advancements in maternal-fetal medicine and neonatal care, such as improved prenatal imaging techniques for better diagnosis and monitoring, and the use of ex-utero intrapartum treatment (EXIT) procedures. Additionally, there is ongoing research into the use of stem cell therapy and regenerative medicine to promote lung growth and repair. These alternatives aim to enhance the safety and effectiveness of CDH treatment while minimizing risks to both the mother and fetus.

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Device

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO Trial)

N/A

Recruiting

Led By Yair Blumenfeld, MD

Research Sponsored by Yair Blumenfeld

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

FETO Trial Summary

This trial will study the use of a balloon to block the trachea of a fetus with severe CDH, in order to see if this improves the chances of the baby's survival.

Who is the study for?

This trial is for pregnant women aged 18-50 with a single fetus diagnosed with severe congenital diaphragmatic hernia (CDH). They must stay near LPCH Stanford, plan to deliver there, and have normal genetic testing results. Excluded are those with latex allergies, certain CDH measurements, placental abnormalities, maternal infections like HIV or Hepatitis B/C, high risk of preterm labor/delivery, significant obesity (BMI >40), or involvement in another study affecting outcomes.Check my eligibility

What is being tested?

The FETO Goldballoon procedure by Balt medical is being tested for its effectiveness in treating severe CDH in fetuses. The balloon will be inserted endoscopically into the fetal trachea at LPCH Stanford which has specialized maternal-fetal medicine and neonatal services including ECMO and pediatric surgery.See study design

What are the potential side effects?

While specific side effects are not listed here, interventions like FETO may carry risks such as premature birth or complications from the surgical procedure itself. There could also be potential risks associated with anesthesia during the operation.

FETO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of neonates who survive until initial hospital discharge

Secondary outcome measures

Oxyhemoglobin

Number of children who survive until 1 year of age

Number of children who survive until 2 years of age

+2 more

FETO Trial Design

1Treatment groups

Experimental Treatment

Group I: Fetal Endoscopic Tracheal Occlusion (FETO)Experimental Treatment1 Intervention

FETO is performed in-utero and the balloon is removed prior to delivery, and children will have follow-up visits until the age of 2

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Fetal Endoscopic Tracheal Occlusion (FETO) is a procedure used to treat severe congenital diaphragmatic hernia (CDH) by promoting lung growth. During FETO, a balloon is inserted into the fetal trachea to temporarily block it, which increases pressure within the developing lungs. This pressure stimulates lung growth and development, which is crucial for CDH patients as their lungs are often underdeveloped due to the hernia. By enhancing lung growth before birth, FETO aims to improve the chances of survival and reduce the severity of respiratory complications after birth. This intervention is particularly important for severe cases of CDH where traditional postnatal treatments may not be sufficient.

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Who is running the clinical trial?

Yair BlumenfeldLead Sponsor

Yair Blumenfeld, MDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

200 Total Patients Enrolled

Media Library

Balt Goldballoon (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05461222 — N/A

Congenital Diaphragmatic Hernia Research Study Groups: Fetal Endoscopic Tracheal Occlusion (FETO)

Congenital Diaphragmatic Hernia Clinical Trial 2023: Balt Goldballoon Highlights & Side Effects. Trial Name: NCT05461222 — N/A

Balt Goldballoon (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05461222 — N/A

~7 spots leftby Aug 2025

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