Smart Removal for Congenital Diaphragmatic Hernia
Recruiting now · Not applicable
Conditions studied: Congenital Diaphragmatic Hernia
In brief
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.
Key facts
- Study ID
- NCT05100693
- Run by
- Universitaire Ziekenhuizen KU Leuven
- People needed
- 25
- Starts
- 2021-09-08
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2021-10-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Participants eligible for this Trial must not meet any of the following criteria:
- History of allergy to latex
- Contraindication to fetoscopy and FETO (maternal diseases or technical limitations making prenatal surgery hazardous or impossible)
- Premature Membrane Rupture (PROM)
- Multiple pregnancy
- Maternal age less than 18 years
- Refusal to stay close to the UZ Leuven until balloon removal
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Participation in another interventional trial with an investigational medicinal product (IMP) or device
Where it is running
- UZ Leuven — Leuven, Belgium (enrolling)
Full record on ClinicalTrials.gov
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