Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe CDH
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNYU Langone Health
About this trial
The purpose of this pilot study is to evaluate the feasibility of using Fetoscopic Endoluminal Tracheal Occlusion (FETO) in 10 pregnant individuals carrying fetuses with severe congenital diaphragmatic hernia (CDH). FETO surgery will be performed at 27 weeks - 29 weeks and 6 days of gestation, and the fetoscopic removal of the balloon will be performed at 34 weeks - 34 weeks and 6 days of gestation. The primary endpoint is successful placement and removal of the balloon.
Eligibility criteria
Qualifiers
Provision of a signed and dated informed consent form
Pregnant individuals age 18 years and older
Singleton pregnancy
A normal karyotype with confirmation by culture results, CMA with non-pathologic variants, whole exome or genome sequencing (WES or WGS).
Disqualifiers
Natural rubber latex allergy
Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI or echocardiogram at the fetal treatment center.
Signs of preterm labor, cervix shortened to ≤20 mm at enrollment or at 24 hours prior to FETO balloon insertion procedure) or a uterine anomaly strongly predisposing to preterm labor.
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
Trial design
Treatments tested in this trial
- Goldballoon Detachable Balloon (GOLDBAL2)
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov