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Procedure

Balloon Arm for Congenital Diaphragmatic Hernia

N/A

Waitlist Available

Research Sponsored by University of Wisconsin, Madison

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth to 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ birth to 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

FETO placement and release operative times

Maternal Complications

Number of successful placements of Goldballoon Detachable Balloon at gestational age 27 weeks 0 days (27w0d) to 29 weeks 6 days (29w6d)

+1 more

Secondary outcome measures

Change in fetal lung growth

Gestational age at delivery

Infant survival

+5 more

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,186 Previous Clinical Trials

3,169,427 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"Apologies for the confusion. According to clinicaltrials.gov, this particular study is no longer accepting participants as of its last update on December 19th, 2023. However, it's important to note that there are currently 161 other ongoing clinical trials actively seeking eligible participants at this time."

Answered by AI

Who is eligible to participate in this clinical study?

"To be eligible for enrollment in this clinical trial, individuals must have a diagnosis of congenital diaphragmatic hernia and fall within the age range of 18 to 50 years old. The study aims to recruit a total of 20 participants."

Answered by AI

What is the primary goal of this medical study?

"This clinical trial aims to evaluate the duration of FETO placement and release procedures within a timeframe spanning from 27 weeks and 0 days to 29 weeks and 6 days. Secondary outcomes will include the number of days spent in NICU/PICU, which refers to neonatal admission duration, usage of ECMO support, indicating infants requiring extracorporeal membrane oxygenation (ECMO), as well as gestational age at delivery."

Answered by AI

Is the age criteria for participation in this study limited to individuals below 65 years of age?

"To be eligible for this clinical trial, participants must fall within the age range of 18 to 50. It is worth noting that there are a total of 20 ongoing trials specifically designed for individuals under the age of 18 and an additional 127 trials focusing on patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fetoscopic Endoluminal Tracheal Occlusion for Severe Left and Right Congenital Diaphragmatic Hernia

2025. "Fetoscopic Endoluminal Tracheal Occlusion for Severe Left and Right Congenital Diaphragmatic Hernia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06179472.

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