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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2021-09-08 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05100693 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Congenital Diaphragmatic Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05100693 currently recruiting?
Yes, NCT05100693 is actively recruiting participants. Contact the research team at jan.deprest@uzleuven.be for enrollment information.
Where is the NCT05100693 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05100693 clinical trial?
NCT05100693 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 25 participants.