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FETO Therapy for Congenital Diaphragmatic Hernia (FETO Trial)

Q: What are the desired outcomes of this experimental endeavor?

The 29 week 6 day long trial seeks to achieve successful removal of the Balt Goldbal2 balloon and will track gestational age at delivery, infant survival from birth through NICU discharge as well as 6, 12, and 24 months after that. Additionally, researchers are monitoring any infants requiring Extra Corporeal Membrane Oxygenation (ECMO) support during their hospital stay.

Q: Are enrollees currently being accepted for participation in this experiment?

Precisely, information from clinicaltrials.gov verifies that the recruitment process for this medical trial is still ongoing. It was first posted on April 1st 2023 and updated most recently on March 14th 2023.

Q: How many individuals are currently receiving treatment in the course of this experiment?

Affirmative. According to the information hosted on clinicaltrials.gov, this trial is actively searching for subjects and went live on April 1st 2023; its last update was registered on March 14th of that same year. 10 patients are being sought from a single research centre.

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

FETO Trial 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.Check my eligibility

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.See study design

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.

FETO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years of age

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

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

Primary outcome measures

Successful placement of Balt Goldbal2 balloon

Successful removal of Balt Goldbal2 balloon

Secondary outcome measures

Change in fetal lung growth

Gestational age at delivery

Infant survival

+4 more

FETO Trial Design

1Treatment groups

Experimental Treatment

Group I: FETO therapyExperimental Treatment1 Intervention

FETO therapy

Do I qualify?Apply below to find out

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

56 Previous Clinical Trials

1,175,204 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

Frequently Asked Questions

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

What are the desired outcomes of this experimental endeavor?

"The 29 week 6 day long trial seeks to achieve successful removal of the Balt Goldbal2 balloon and will track gestational age at delivery, infant survival from birth through NICU discharge as well as 6, 12, and 24 months after that. Additionally, researchers are monitoring any infants requiring Extra Corporeal Membrane Oxygenation (ECMO) support during their hospital stay."

Answered by AI

Are enrollees currently being accepted for participation in this experiment?

"Precisely, information from clinicaltrials.gov verifies that the recruitment process for this medical trial is still ongoing. It was first posted on April 1st 2023 and updated most recently on March 14th 2023."

Answered by AI

How many individuals are currently receiving treatment in the course of this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this trial is actively searching for subjects and went live on April 1st 2023; its last update was registered on March 14th of that same year. 10 patients are being sought from a single research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fetoscopic Endoluminal Tracheal Occlusion

2024. "Fetoscopic Endoluminal Tracheal Occlusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05771688.

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