Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

ConditionCongenital Diaphragmatic Hernia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-50

SponsorMauro H. Schenone

About this trial

The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).

Eligibility criteria

Qualifiers

Singleton pregnancy

Normal fetal karyotype or microarray. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks

Isolated severe left CDH with O/E LHR < 25% )

Gestation age at enrollment prior to 29 wks plus 6 days.

Disqualifiers

Multi-fetal pregnancy

History of natural rubber latex allergy

Preterm labor, cervix shortened (<20 mm) at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor

Psychosocial ineligibility, precluding consent: inability to reside within 30 minutes of Mayo Clinic, Rochester and inability to comply with the travel for the follow-up requirements of the trial; patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Mayo Clinic

Trial design

Treatments tested in this trial

BALT GOLDBALL 2 detachable latex ballon
BALTACCIBDPE100 Microcatheter
Storz fetoscopic operating sheath and miniature telescope/fetoscope

Treatment groups

20 Participants

are divided into 1 treatment group

Sponsors and collaborators

Mauro H. Schenone

Lead sponsor

Mayo Clinic

Sponsor institution

Source ClinicalTrials.gov