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Device

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

N/A

Waitlist Available

Led By Rodrigo Ruano, MD, Ph.D.

Research Sponsored by Rodrigo Ruano

Eligibility Criteria Checklist

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

Must have

Isolated Left CDH with liver up

Be between 18 and 65 years old

Must not have

Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy

History of incompetent cervix with or without cerclage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months post partum

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new procedure to see if it is safe and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include risks associated with any fetal surgery such as preterm labor, infection, or complications from the balloon catheter system used during FETO.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a health condition that prevents me from having surgery during pregnancy.

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I have had issues with my cervix opening too early during pregnancy.

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I have a short cervix or conditions increasing my risk of early labor.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post partum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months post partum

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post partum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of unplanned balloon removal

Gestational Age at Delivery

Number of incidences of maternal complications

+3 more

Secondary study objectives

Fetal Lung Growth as measured via Fetal Lung Volume

Fetal Lung Growth as measured via LHR

Fetal survival

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FETO GroupExperimental Treatment2 Interventions

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

0 / 5Eligibility criteria met