Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Hanmin Lee, MD (ucsf)
Headshot of Hanmin Lee
Hanmin Lee

Description

Summary

Despite advances in prenatal diagnosis and postnatal therapies, including ECMO (Extracorporeal Membrane Oxygenation), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with severe CDH remain high. The rationale for fetal therapy in severe CDH is to promote adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. The investigator's goal with this pilot study is to study the feasibility of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with left CDH (LHR O/E < 25%).

Keywords

Congenital Diaphragmatic Hernia, Hernias, Diaphragmatic, Congenital, Hernia, Diaphragmatic Hernia, Fetoscopic Endoluminal Tracheal Occlusion Surgery

Eligibility

Location

  • University of California San Francisco Fetal Treatment Center accepting new patients
    San Francisco California 94158 United States

Lead Scientist at University of California Health

  • Hanmin Lee, MD (ucsf)
    Professor, Surgery, School of Medicine. Authored (or co-authored) 5 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hanmin Lee
Links
UCSF Fetal Treatment Center website
ID
NCT04583644
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated