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Procedure

Goldballoon Detachable Balloon and delivery microcatheter for Congenital Diaphragmatic Hernia (FETO Trial)

N/A

Waitlist Available

Led By Michael Belfort, MD, PhD

Research Sponsored by Michael A Belfort

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 years of age

Awards & highlights

FETO Trial Summary

This trial is a study to test a new technique to help babies born with a congenital diaphragmatic hernia. The new technique is fetal tracheal occlusion (FETO), which is a way to temporarily close the herniated area with a Goldvalve balloon to allow the lungs to develop. The trial will test the feasibility of performing the procedure and managing the pregnancy during the period of tracheal occlusion.

Eligible Conditions

Congenital Diaphragmatic Hernia

FETO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 years of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 years of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 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

2-year Survival

Secondary outcome measures

Maternal Outcomes- Maternal Morbidity- Placental abruption

Maternal Outcomes- Maternal Morbidity- Rupture of membranes

Maternal Outcomes- Maternal Morbidity- chorioamnionitis

+18 more

FETO Trial Design

1Treatment groups

Experimental Treatment

Group I: Fetal Endotracheal OcclusionExperimental Treatment1 Intervention

Placement and retrieval of the GoldBAL4 or GoldBal2 Detachable balloon using the plug/unplug method, using BALTACCIDBPE100 Delivery Catheter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Goldballoon Detachable Balloon and delivery microcatheter

2012

N/A

~20

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Find a Location

Who is running the clinical trial?

Michael A BelfortLead Sponsor

4 Previous Clinical Trials

485 Total Patients Enrolled

Baylor College of MedicineOTHER

1,001 Previous Clinical Trials

6,001,932 Total Patients Enrolled

Michael Belfort, MD, PhDPrincipal InvestigatorBaylor College of Medicine - Texas Children's Hospital

2 Previous Clinical Trials

6 Total Patients Enrolled

Media Library

Goldballoon Detachable Balloon and delivery microcatheter (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT00881660 — N/A

Congenital Diaphragmatic Hernia Research Study Groups: Fetal Endotracheal Occlusion

Congenital Diaphragmatic Hernia Clinical Trial 2023: Goldballoon Detachable Balloon and delivery microcatheter Highlights & Side Effects. Trial Name: NCT00881660 — N/A

Goldballoon Detachable Balloon and delivery microcatheter (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00881660 — N/A

Frequently Asked Questions

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

Are enrollment applications currently being accepted for this trial?

"The information available on clinicaltrials.gov suggests that this study is no longer recruiting patients. The trial was initially posted on March 1st, 2010 and was most recently edited on January 7th, 2022. Although this particular trial has completed recruitment, there are 172 other trials currently seeking candidates."

Answered by AI

Are there any prerequisites to signing up for this trial?

"20 individuals, who have been diagnosed with morgagni hernias and are between 18-45 years old, are needed for this study. Furthermore, the participants must be willing to remain in Houston after the balloon placement until delivery. Lastly, the mother must be healthy enough to endure surgery."

Answered by AI