Smart Removal for Congenital Diaphragmatic Hernia

Recruiting N/A Interventional Study
Congenital Diaphragmatic Hernia
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
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About This Trial

The purpose of this study is to demonstrate the ability to prenatally deflate and to evaluate the safety of the Smart-TO device for fetoscopic endoluminal tracheal occlusion (FETO) in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Women carrying a fetus with isolated CDH eligible for FETO, i.e. with severe or moderate hypoplasia: * Left sided CDH with severe (i.e. quotient of observed-to-expected- lung-to-head ratio under 25%) or moderate pulmonary hypoplasia (observed-to-expected- lung-to-head ratio…
Contacts

Jan Depret, PhD, MD

+3216345123

jan.deprest@uzleuven.be

CONTACT

David Basurto, MD

+3216341974

david.basurto@uzleuven.be

CONTACT