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Procedure

FETO Surgery for Congenital Diaphragmatic Hernia

N/A
Recruiting
Led By Hanmin Lee, MD
Research Sponsored by Hanmin Lee
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
SEVERE pulmonary hypoplasia with US LHR O/E < 25% (measured at 180 to 295 weeks) at the time of surgery
Must not have
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
There is no safe or technically feasible fetoscopic approach to balloon placement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after birth
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new fetal therapy for babies with severe Congenital Diaphragmatic Hernia (CDH). The goal is to improve neonatal survival rates by increasing lung growth while the baby is still in the womb.

Who is the study for?
This trial is for pregnant women over 18 with a single pregnancy and severe left CDH in the fetus, where the liver has moved into the chest. Participants must have normal fetal chromosomes, be at 27-29 weeks gestation for surgery, meet psychosocial criteria, consent to participate, and secure payment or insurance coverage.
What is being tested?
The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery on fetuses with severe lung underdevelopment due to CDH. The goal is to see if blocking the trachea prenatally can improve lung growth before birth.
What are the potential side effects?
Potential side effects of FETO may include risks associated with any surgical procedure during pregnancy such as preterm labor or complications from anesthesia. Specifics are not listed but would be discussed in detail prior to consent.

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 unborn baby has a severe lung problem diagnosed by ultrasound.
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My condition involves the left side of my diaphragm being affected with my liver positioned higher than normal.

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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A balloon cannot be safely placed in the fetus using a scope.
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I have a short cervix or conditions increasing my risk of early labor.
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I have had a weak cervix, with or without a stitch.
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I have a uterine condition like fibroids or a developmental abnormality.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of effective placements of balloon to occlude trachea via fetoscopy
Secondary study objectives
Determine survival rate of FETO patients
Rate of fetal lung growth after FETO as measured by Lung to head circumference ratio
Rate of fetal lung growth after FETO as measured by lung volume.

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: Device - FETOExperimental Treatment1 Intervention
Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of balloon using the BALT GOLDBAL2 balloon and BALTACCIBDPE100 catheter.

Find a Location

Who is running the clinical trial?

Hanmin LeeLead Sponsor
Hanmin Lee, MDPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
2 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

Fetoscopic Endoluminal Tracheal Occlusion (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04583644 — N/A
Congenital Diaphragmatic Hernia Research Study Groups: Device - FETO
Congenital Diaphragmatic Hernia Clinical Trial 2023: Fetoscopic Endoluminal Tracheal Occlusion Highlights & Side Effects. Trial Name: NCT04583644 — N/A
Fetoscopic Endoluminal Tracheal Occlusion (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04583644 — N/A
~4 spots leftby Apr 2027
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