CompletedNot Applicable

Fetoscopic Endoluminal Tracheal Occlusion (FETO) With Smart-TO

France23 participantsStarted 2021-08-04

Plain-language summary

The purpose of this study is to make the proof of concept and to evaluate the safety of fetoscopic endoluminal tracheal occlusion (FETO) using Smart-TO device in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 18 years or more, who are able to consent, and affiliated to social security * Singleton pregnancy with fetus with isolated left-sided congenital diaphragmatic hernia (no additional malformation nor chromosomal abnormality) and: Severe pulmonary hypoplasia defined as observed on expected 'lung-to-head ration' (O/E LHR) \<25% irrespective of the liver position as measured between 27wks and 29wks + 6 days Or Moderate pulmonary hypoplasia defined as O/E LHR 25-34.9% (liver up or down) or O/E LHR 35-44.9% with liver up as measured between 30wks and 31wks + 6 days Exclusion Criteria: * Maternal contraindication to fetoscopic surgery * Preterm premature rupture of the membranes (PPROM) or condition strongly predisposing to PPROM or premature delivery * Impossibility of remain close to the FETO center during the fetal occlusion period

What they're measuring

Deflation of the Smart-TO balloon after exposure to the fringe field of the MRI

Timeframe: Between 34 and 34+6 amenorrhea weeks

Expelling of the Smart-TO balloon outside the airways

Timeframe: At birth

Trial details

NCT IDNCT04931212

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-14

View on ClinicalTrials.gov More Congenital Diaphragmatic Hernia trials