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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT02549820
Eligibility Criteria:
Inclusion Criteria:
1. Pregnant women age 18 years and older, who are able to consent
2. Singleton pregnancy
Fetal:
3. Normal Karyotype or chromosomal microarray with non-pathologic variants
4. Diagnosis of Isolated Left CDH with liver up
5. Gestation at enrollment prior to 29 weeks plus 5 days
6. SEVERE pulmonary hypoplasia with Ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) \< 25%
Exclusion Criteria:
1. Pregnant women \< 18 years
2. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
3. Technical limitations precluding fetoscopic surgery
4. Rubber latex allergy
5. Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
6. Psychosocial ineligibility, precluding consent
7. Fetal Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
8. Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02549820
Study Brief:
Protocol Section:
NCT02549820