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Procedure

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) for Congenital Diaphragmatic Hernia (FETO Trial)

N/A

Recruiting

Led By Erin Perrone, MD

Research Sponsored by Dr Erin Perrone

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 baseline (before balloon placement), immediately prior to balloon retrieval

Awards & highlights

FETO Trial Summary

This trial is to test the feasibility and safety of a new treatment for severe CDH. It will enroll pregnant women who meet the criteria and who live close to the hospital. There are some lifestyle considerations that the participants must be aware of.

Who is the study for?

This trial is for pregnant women with a baby diagnosed with severe Congenital Diaphragmatic Hernia (CDH). Participants must live within 30 miles of the Von Voigtlander Women's Hospital, have support throughout pregnancy, and be willing to follow study procedures without working or engaging in normal activities like exercise.Check my eligibility

What is being tested?

The trial tests Fetal Endoscopic Tracheal Occlusion (FETO) using a Goldballoon Detachable Balloon and Delivery Microcatheter on babies with CDH. It aims to see if this treatment is safe and doable at Michigan Medicine between 27-29 weeks' gestation.See study design

What are the potential side effects?

Specific side effects are not listed, but as it involves fetal surgery, potential risks may include preterm labor, membrane rupture, or complications related to the procedure. Close monitoring will occur due to these possible risks.

FETO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 27w0d - 29w6d

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~27w0d - 29w6d

This trial's timeline: 3 weeks for screening, Varies for treatment, and 27w0d - 29w6d for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation.

Number of successful retrievals of the GOLDBAL2

Secondary outcome measures

Change in fetal lung growth

Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)

Gestational age at delivery

+2 more

FETO Trial Design

1Treatment groups

Experimental Treatment

Group I: FETO with GOLDBAL2Experimental Treatment1 Intervention

A balloon will be placed in the airway of the fetus during the FETO procedure.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dr Erin PerroneLead Sponsor

Erin Perrone, MDPrincipal Investigator - University of Michigan

University of Michigan Hospital, Von Voigtlander Women's Hospital

Wayne State University School Of Medicine (Medical School)

Frequently Asked Questions

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

Is enrollment still available for this investigation?

"Per the data hosted on clinicaltrials.gov, this experiment is actively recruiting participants as of now; It was originally posted in April 2021 and most recently edited in March 2022."

Answered by AI

How many participants are being monitored for this investigation?

"Affirmative. According to information on clinicaltrials.gov, this scientific investigation is actively searching for volunteers and was initially posted on April 5th 2021; the listing's most recent update occurred on March 8th 2022. The trial seeks 10 patients from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)

Dr Erin Perrone 2021. "Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04052828.

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