FETO Therapy for Diaphragmatic Hernia (FETO Trial)

N/A

Recruiting

Led By Anthony Johnson, DO

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

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

Must have

Pregnant women age 18 years and older

Isolated Left CDH with liver up

Must not have

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

Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after insertion of balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new fetal treatment for left Congenital Diaphragmatic Hernia. If successful, it could be used in future trials with more patients.

Who is the study for?

This trial is for pregnant women over 18 with a single pregnancy and severe left Congenital Diaphragmatic Hernia (CDH) in the fetus. Eligible participants must have an LHR less than 30%, be able to stay near the hospital, and not have any conditions that risk mother or baby during surgery.

What is being tested?

The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy's safety and feasibility on fetuses with severe CDH. It's a preliminary study at UTHealth to see if they can join larger multi-center trials later.

What are the potential side effects?

Potential side effects are not explicitly listed but may include risks associated with fetal surgeries such as preterm labor, complications from anesthesia, infection, or harm to the fetus.

Eligibility Criteria

Inclusion Criteria

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

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I am pregnant and 18 years or older.

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My condition involves a left-sided diaphragmatic hernia with the 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 a uterine condition like fibroids or a developmental abnormality.

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

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My unborn baby has a diaphragm issue on the right side, both sides, or isolated left with specific lung measurement.

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I am under 18 years old.

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A safe method to place a balloon in the womb through a scope is not possible for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after insertion of balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after insertion of balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after insertion of balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age) for reporting.