The goal is to assess the feasibility and safety of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia (CDH) at UTHealth. UTHealth's success in this study (with an initial 5 patients) will determine the feasibility of UTHealth's future participation in multi-center trials of this intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
22
Fetoscopic surgery at 27 to 31 weeks and 6 days gestation.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Successful placement of Balt Goldbal2 balloon
Time frame: 7 weeks after placement
Successful removal of Balt Goldbal2 balloon
Time frame: within 5 weeks prior to delivery
Gestational age at delivery
Time frame: at delivery
Lung volume
Time frame: 7 weeks after placement of balloon
Lung head ratio
Time frame: 7 weeks after placement of balloon
Survival at 30 days
Time frame: 30 days post delivery
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