NCT05100693 Smart Removal for Congenital Diaphragmatic Hernia
| NCT ID | NCT05100693 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Congenital Diaphragmatic Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2021-09-08 |
| Primary Completion | 2026-08-01 |
Trial Parameters
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Brief Summary
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.
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 ratios of 25 to 34.9% (any liver position), or 35 to 44.9% with intrathoracic liver herniation) * Right sided CDH with severe pulmonary hypoplasia (quotient of observed-to-expected- lung-to-head ratio under 50%) * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures * Maternal age of 18 years or older * Single pregnancy * Signed informed consent * Consent to have an ultrasound of the uterus after delivery when indicated * Postnatal management center agrees to participate Exclusion Criteria: Participants eligible for this Trial must not meet any of the following criteria: * History of allergy to latex * Con