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:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT02710968
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women age 18 years and older, who are able to consent.
* Singleton pregnancy.
* Anatomically and chromosomally normal fetus.
* Left sided diaphragmatic hernia with liver up.
* SEVERE pulmonary hypoplasia with O/E LHR \< 30%.
* In patients with O/E LHR 25% to \<30%, enrollment prior to gestational age 30 weeks+0 days to 31 weeks+6 days.
* In patients with O/E LHR \<25%, enrollment prior to gestational age 27 weeks+0 days to 29 weeks+6 days.
Exclusion Criteria:
* Pregnant women \< 18 years.
* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy.
* Technical limitations precluding fetoscopic surgery.
* Women with history of natural rubber latex allergy.
* Preterm labor, cervix shortened \<15 mm within 24 hours prior to the FETO balloon insertion or uterine anomaly strongly predisposing to preterm labor, placenta previa.
* Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 30%.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02710968
Study Brief:
Protocol Section:
NCT02710968