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Procedure

FETO for Congenital Diaphragmatic Hernia (FETO Trial)

N/A
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR <25% with liver up
No pathogenic variants on microarray or pathologic findings on karyotype
Must not have
Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (before balloon placement), immediately prior to balloon retrieval
Awards & highlights

Summary

This trial tests a procedure where a small balloon is placed in the unborn baby's windpipe to help their lungs develop better. It targets pregnant women whose babies have severe lung development issues. The balloon helps the lungs grow by trapping fluid inside them. This procedure has been developed and tested for many years to help unborn babies with severe lung development issues.

Who is the study for?
This trial is for pregnant women over 18 with a single pregnancy and severe Congenital Diaphragmatic Hernia (CDH) in the fetus. Participants must live within 30 minutes of UC Davis Medical Center, have no major fetal cardiac defects or additional abnormalities, and agree to lifestyle restrictions including not working or engaging in exercise and intercourse.
What is being tested?
The study tests Fetal Endoscopic Tracheal Occlusion using GOLDBAL2 balloon and BALTACCI-BDPE100 microcatheter on fetuses with CDH. The procedure occurs between 27-29 weeks' gestation, with removal around week 34, monitored by UC Davis Medical Center.
What are the potential side effects?
Potential side effects may include complications from the fetoscopic surgery such as preterm labor or damage to the uterus or fetus. There might also be risks associated with living under restricted conditions affecting mental well-being.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My unborn baby has severe lung issues due to CDH, with a very low lung-to-head ratio.
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My genetic tests did not show any harmful changes.
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I am pregnant and 18 years or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My baby has been diagnosed with a condition that could affect their health after birth.
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I do not have HIV, Hepatitis B, or Hepatitis C.
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My baby has a diaphragmatic hernia with specific lung and liver positioning.
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I have known significant issues with my placenta.
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I am unable to give consent for myself.
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It's not safe or possible for me to have a balloon placed via fetoscopy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 weeks 0 days to 29 weeks 6 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 weeks 0 days to 29 weeks 6 days 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 successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation.
Number of successful retrievals of the GOLDBAL2
Secondary study objectives
Change in fetal lung growth
Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)
Number of maternal complications
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: FETO with GOLDBAL2Experimental Treatment1 Intervention
A balloon will be placed in the airway of the fetus during the FETO procedure.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Fetal Endoscopic Tracheal Occlusion (FETO) is a procedure used to treat severe Congenital Diaphragmatic Hernia (CDH) by occluding the fetal trachea with a detachable balloon. This occlusion prevents the escape of lung fluid, thereby increasing intrapulmonary pressure and promoting lung growth and development. This is crucial for CDH patients because the herniation of abdominal organs into the chest cavity impairs lung development, leading to pulmonary hypoplasia and respiratory distress after birth. By enhancing lung growth before birth, FETO aims to improve postnatal respiratory function and overall outcomes for infants with severe CDH.

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
932 Previous Clinical Trials
4,721,333 Total Patients Enrolled

Media Library

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05421676 — N/A
Congenital Diaphragmatic Hernia Research Study Groups: FETO with GOLDBAL2
Congenital Diaphragmatic Hernia Clinical Trial 2023: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) Highlights & Side Effects. Trial Name: NCT05421676 — N/A
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05421676 — N/A
~7 spots leftby Dec 2027