NCT03674372 Fetoscopic Endoluminal Tracheal Occlusion
| NCT ID | NCT03674372 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Congenital Diaphragmatic Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2018-11-16 |
| Primary Completion | 2030-03 |
Eligibility & Interventions
Eligibility Fast-Check
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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 10 participants in total. It began in 2018-11-16 with a primary completion date of 2030-03.
⚠ 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 research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.
Eligibility Criteria
Inclusion Criteria: * Pregnant women age 18 years and older, who are able to consent * Singleton pregnancy Fetal * Normal Karyotype * Fetal Diagnosis of Isolated Left or Right CDH with liver up * Gestation at enrollment prior to 29 wks plus 6 days * SEVERE pulmonary hypoplasia with Ultra Sound L-sided O/E LHR \< 25% or R-sided O/E LHR \<45% Exclusion Criteria: * Pregnant women \<18 years of age. * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy * Technical limitations precluding fetoscopic surgery * Rubber latex allergy * 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 * Psychosocial ineligibility, precluding consent * Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03674372 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 NCT03674372 currently recruiting?
Yes, NCT03674372 is actively recruiting participants. Contact the research team at elizabeth.torres@childrenscolorado.org for enrollment information.
Where is the NCT03674372 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT03674372 clinical trial?
NCT03674372 is sponsored by University of Colorado, Denver. The trial plans to enroll 10 participants.