Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT05100693
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05100693
Study Brief:
Protocol Section:
NCT05100693