Fetoscopic Endoluminal Tracheal Occlusion
ConditionCongenital Diaphragmatic Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Colorado, Denver
About this trial
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
Qualifiers
Pregnant women age 18 years and older, who are able to consent
Singleton pregnancy
Normal Karyotype
Fetal Diagnosis of Isolated Left or Right CDH with liver up
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Treatment groups
10 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov