Fetoscopic Endoluminal Tracheal Occlusion for Severe CDH

JL
EL
Overseen ByErin Lonergan, MHA, BSN, RN
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this pilot study is to evaluate the feasibility of using Fetoscopic Endoluminal Tracheal Occlusion (FETO) in 10 pregnant individuals carrying fetuses with severe congenital diaphragmatic hernia (CDH). FETO surgery will be performed at 27 weeks - 29 weeks and 6 days of gestation, and the fetoscopic removal of the balloon will be performed at 34 weeks - 34 weeks and 6 days of gestation. The primary endpoint is successful placement and removal of the balloon.

Who Is on the Research Team?

JL

Jose L. Peiro, MD, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Inclusion Criteria

My baby has severe right-sided CDH with low lung size and liver up, diagnosed between 18-30 weeks.
Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work
Singleton pregnancy
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Exclusion Criteria

I have a medical condition that makes fetoscopic surgery unsafe during pregnancy.
Placental abnormalities known at time of enrollment including previa, abruption, accreta, chorioangioma
Participation in another intervention study influencing maternal and fetal morbidity and mortality
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What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Congenital diaphragmatic hernia (CDH)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+