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Procedure

FETO Surgery for Congenital Diaphragmatic Hernia

N/A
Recruiting
Led By Inna Lobeck
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant persons age 18 years and older
Patient has a support person (e.g. spouse, partner, friend, or parent) that is available to stay with her for the duration of the pregnancy
Must not have
Pregnant persons < 18 years of age
Adult unable to consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to investigate whether a specific type of surgery, called FETO surgery, can be safely performed at UW Health Fetal Diagnosis and Treatment Center and American Family Children's Hospital. The researchers believe

Who is the study for?
This trial is for individuals with severe left or right Congenital Diaphragmatic Hernia (CDH). Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.
What is being tested?
The trial is testing the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) using the BALT GOLDBALL2 Balloon. The goal is to see if this treatment improves survival rates and reduces complications compared to standard care.
What are the potential side effects?
While specific side effects are not listed, procedures like FETO can carry risks such as preterm labor, membrane rupture, or balloon dislodgement. Any surgical intervention may also lead to infection or reaction to anesthesia.

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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I have someone to stay with me throughout my pregnancy.
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My baby does not have genetic issues based on prenatal tests.
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My baby has a diaphragmatic hernia without other severe health issues.

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 am unable to give consent for medical procedures.
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I do not have someone to stay with me during my treatment or pregnancy.
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My unborn baby has been diagnosed with CDH and meets the specific ultrasound criteria.
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I have had issues with my cervix opening too early during pregnancy.
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I have a uterine condition like fibroids or a developmental abnormality.
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I refuse to receive blood transfusions.
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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 ~birth to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 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
Infant survival
Number of occurrences and severity of pulmonary hypertension
Use of Extracorporeal Membrane Oxygenation (ECMO) support
Secondary study objectives
Change in fetal lung growth
Gestational age at delivery
Maternal Complications
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Balloon ArmExperimental Treatment1 Intervention
Participants who consent to the insertion and the removal of the Balt GOLDBAL2 Balloon.
Group II: No TreatmentActive Control1 Intervention
Patients who have been diagnosed with severe CDH at our site but choose not to participate in the study.

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
256 Previous Clinical Trials
940,315 Total Patients Enrolled
NAFTNet FETO ConsortiumUNKNOWN
University of Wisconsin, MadisonOTHER
1,231 Previous Clinical Trials
3,199,865 Total Patients Enrolled
~13 spots leftby Jan 2031
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