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Device

Tracheal Occlusion for Congenital Diaphragmatic Hernia (CHOP_FETO Trial)

N/A

Recruiting

Led By Holly L Hedrick, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

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

Must have

Fetal: Normal Karyotype or chromosomal microarray with non-pathologic variants

Pregnant women age 18 years and older, who are able to consent

Must not have

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

Technical limitations precluding fetoscopic surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to treat CDH before birth.

Who is the study for?

This trial is for pregnant women over 18 with a single pregnancy and a fetus diagnosed with severe left Congenital Diaphragmatic Hernia (CDH), where the liver has moved up. The baby must have an O/E LHR less than 25%, indicating serious lung underdevelopment, and be no more than 29 weeks + 5 days into gestation.

What is being tested?

The study tests a procedure using GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter to temporarily block the trachea of fetuses in utero. This may help lungs grow by keeping fluid within them, potentially improving survival rates after birth for babies with severe CDH.

What are the potential side effects?

Possible side effects include risks associated with fetoscopic surgery such as preterm labor, injury to the mother or fetus, infection risk, or complications from anesthesia. Specific side effects related to the balloon device are not detailed but could involve reactions at the insertion site.

Eligibility Criteria

Inclusion Criteria

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

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My unborn baby's genetic tests are normal.

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I am a pregnant woman, 18 or older, and can give consent.

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My condition involves a left-sided diaphragmatic hernia with liver displacement.

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My unborn baby has severe lung underdevelopment with an O/E LHR below 25%.

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 cannot have surgery using a scope due to technical reasons.

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I cannot stay at the hospital for the duration of my treatment and aftercare.

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My unborn baby has a diaphragmatic hernia with specific conditions.

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I am pregnant and under 18.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Successful balloon placement and removal.

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 in CDHExperimental Treatment1 Intervention

Fetoscopic Endoluminal Tracheal Occlusion (FETO) will be performed by placing a detachable balloon inside the fetal airway and removing the balloon after several weeks. Devices: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter

0 / 10Eligibility criteria met