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Fetoscopic Endoluminal Tracheal Occlusion

RecruitingNAAges 18 Years - anyFemaleUniversity of Colorado, Denver
NCT03674372 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Fetoscopic Endoluminal Tracheal Occlusion (FETO)
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Where

1 site
Children's Hospital Colorado
Aurora, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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