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Tracheal Occlusion Device

FETO for Congenital Diaphragmatic Hernia (FETO Trial)

N/A
Recruiting
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Maternal age greater than or equal to 18 years
Severe pulmonary hypoplasia with ultrasound O/E LHR <25% at the time of surgery
Must not have
Patient < 18 years old
Bilateral CDH, isolated left sided CDH with an O/E > 30%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial found that, for fetuses with congenital diaphragmatic hernia, tracheal occlusion increased the chance of being born alive and without major surgery.

Who is the study for?
This trial is for pregnant individuals carrying a single fetus with left congenital diaphragmatic hernia, who have decided against terminating the pregnancy. They must be at least 18 years old, willing to stay in Cincinnati for the pregnancy duration, and meet specific gestational age and fetal health criteria. Exclusions include additional fetal anomalies, maternal infections like HIV or Hepatitis B/C, multi-fetal pregnancy, latex allergy, risk of preterm labor.
What is being tested?
The trial tests Feto-Endoscopic Tracheal Occlusion (FETO), a procedure approved by FDA to treat fetuses with congenital diaphragmatic hernia. It involves temporarily blocking the fetal trachea to promote lung growth before birth.
What are the potential side effects?
Potential side effects are not explicitly listed but may include complications from fetoscopic surgery such as premature labor or damage to the uterus or fetus. The procedure carries risks typical of surgeries performed during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My unborn baby has a severe lung problem detected by ultrasound.
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My unborn baby has a lung problem detected by ultrasound.
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My genetic tests for chromosome abnormalities are normal.
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My family and I decided against ending the pregnancy before 24 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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My condition involves a diaphragmatic hernia on both sides or on the left with specific severity.
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I have a health condition that makes surgery during pregnancy risky.
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I am a mother with HIV, Hepatitis B, or Hepatitis C.
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It's not safe or possible for me to have a balloon placed via fetoscopy.
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I am at high risk for early labor due to a short cervix, uterine anomaly, or placenta previa.
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I have a weak cervix, with or without a stitch.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change lung growth on prenatal imaging
Secondary study objectives
Change need for ECMO therapy
Change neonatal morbidity
Change pulmonary hypertension
+1 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: Fetal Tracheal OcclusionExperimental Treatment1 Intervention
Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
834 Previous Clinical Trials
6,564,949 Total Patients Enrolled
Kurt Schibler, MDStudy ChairCCHMC Oversight Data Safety Monitoring Committee
16 Previous Clinical Trials
15,657 Total Patients Enrolled

Media Library

Fetal Tracheal Occlusion (Tracheal Occlusion Device) Clinical Trial Eligibility Overview. Trial Name: NCT02986087 — N/A
Congenital Diaphragmatic Hernia Research Study Groups: Fetal Tracheal Occlusion
Congenital Diaphragmatic Hernia Clinical Trial 2023: Fetal Tracheal Occlusion Highlights & Side Effects. Trial Name: NCT02986087 — N/A
Fetal Tracheal Occlusion (Tracheal Occlusion Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02986087 — N/A
~4 spots leftby Dec 2025
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