NCT05962346 Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
| NCT ID | NCT05962346 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mauro H. Schenone |
| Condition | Congenital Diaphragmatic Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-12 |
| Primary Completion | 2043-07 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Inclusion Criteria: * 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. * Pulmonary hypoplasia with ultrasound O/E LHR \< 25% (measured at 18 0/7 to 29 5/7 weeks) at the time of surgery. * Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound * Patient meets psychosocial criteria: able to reside within 30 minutes of Mayo Clinic, Rochester and able to comply with the travel for the follow-up requirements of the trial; patient has a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Mayo Clinic * Patient is willing and able to give informed consent * Appropriate multi-disciplinary counseling performed with materna