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Device

FETO Therapy for Congenital Diaphragmatic Hernia (FETO Trial)

N/A
Recruiting
Research Sponsored by Children's Hospitals and Clinics of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years of age
Awards & highlights
No Placebo-Only Group

Summary

This trial studies a new fetal procedure that hopes to increase survival rates of babies with severe CDH. It will enroll 10 pregnant people and their baby.

Who is the study for?
This trial is for pregnant women over 18 with a severe case of left-sided congenital diaphragmatic hernia in their fetus (O/E LHR < 25%). They must be at 27-29 weeks gestation, have no other lethal fetal anomalies or major heart defects, and agree to stay within 15 minutes of the Midwest Fetal Care Center.
What is being tested?
The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy on fetuses with severe CDH. It aims to increase lung volume before birth, potentially improving survival rates post-birth. The pilot will enroll ten participants to assess feasibility.
What are the potential side effects?
Potential side effects are not explicitly listed but may include risks associated with fetal surgery such as preterm labor, infection risk for both mother and baby, complications from anesthesia, and possible harm due to the balloon occlusion procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years of 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
Successful placement of Balt Goldbal2 balloon
Successful removal of Balt Goldbal2 balloon
Secondary study objectives
Change in fetal lung growth
Gestational age at delivery
Infant survival
+4 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: FETO therapyExperimental Treatment1 Intervention
FETO therapy

Find a Location

Who is running the clinical trial?

Children's Hospitals and Clinics of MinnesotaLead Sponsor
65 Previous Clinical Trials
5,022,229 Total Patients Enrolled
Allina Health SystemOTHER
57 Previous Clinical Trials
1,177,163 Total Patients Enrolled

Media Library

FETO therapy (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05771688 — N/A
Congenital Diaphragmatic Hernia Research Study Groups: FETO therapy
Congenital Diaphragmatic Hernia Clinical Trial 2023: FETO therapy Highlights & Side Effects. Trial Name: NCT05771688 — N/A
FETO therapy (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05771688 — N/A
~7 spots leftby Feb 2028
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