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Recruiting NCT05354505

Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)

Conditions: Diaphragmatic Hernia

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Vincent Duron

Location: Columbia University Irving Medical Center/NewYork-Presbyterian New York New York

Summary

This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).

Eligibility Criteria

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study 3. Pregnant women, age 18 years and older 4. Singleton pregnancy 5. No pathogenic variants on microarray or pathologic findings on karyotype; results by fluorescence in situ hybridization (FISH) will be acceptable if patient is \>26 weeks 6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects 7. Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05354505). StuddyBuddy aggregates publicly available trial information.