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Balloon-type Device

Fetoscopic Surgery for Congenital Diaphragmatic Hernia (FETO Trial)

N/A
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fetal with normal karyotype
Pregnant women age 18 years and older, who are able to consent
Must not have
Pregnant women <18 years of age
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
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

Summary

This trial is testing whether a new device and surgery can help babies with a severe birth defect called Congenital Diaphragmatic Hernia.

Who is the study for?
This trial is for pregnant women over 18 with a single pregnancy and a fetus diagnosed with severe right or left Congenital Diaphragmatic Hernia (CDH), where the liver has moved up. The baby must have severely underdeveloped lungs, confirmed by ultrasound measurements, and enrollment should be before 29 weeks plus 6 days of gestation.
What is being tested?
The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery on unborn babies with CDH. It involves placing a balloon in the airway to help lung growth by allowing fluid buildup. The safety and effectiveness of both the FETO procedure and its removal are being evaluated.
What are the potential side effects?
Potential side effects may include complications from surgery such as preterm labor, membrane rupture, or infection. There could also be risks associated with anesthesia during the procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My unborn baby has a normal chromosome analysis.
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I am a pregnant woman, 18 or older, and can give consent.
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My unborn baby has been diagnosed with a diaphragmatic hernia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am pregnant and under 18.
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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 am at risk of early labor due to a short cervix or uterine issues.
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I cannot stay at the hospital for the duration of my treatment and aftercare.

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)
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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Successful placement of Balt Goldbal2 balloon
Successful removal of Balt Goldbal2 balloon

Trial Design

3Treatment groups
Experimental Treatment
Group I: Fetuses with R- sided CDH with O/E LHR < 45%Experimental Treatment1 Intervention
Fetuses with Right CDH (O/E LHR \< 45%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Group II: Fetuses with Left CDH (O/E LHR < 25%)Experimental Treatment1 Intervention
Fetuses with Left CDH (O/E LHR \< 25%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Group III: Fetuses with L- sided CDH with O/E LHR <30%.Experimental Treatment1 Intervention
Fetuses with Left CDH (O/E LHR \< 30%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,598 Total Patients Enrolled
~5 spots leftby Mar 2030
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