20
Participants
Start Date
February 21, 2012
Primary Completion Date
April 11, 2023
Study Completion Date
April 11, 2023
Goldballoon Detachable Balloon and delivery microcatheter
"Between 27+0/7 - 29+ 6/7 weeks gestation for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as extremely severe cases of CDH, placement of the Goldvalve detachable balloon. Balloon retrieval will be planned for between 32+0/7 and 34+6/7 weeks or no longer than 10 weeks after balloon placement at the discretion of the FETO center."
Texas Children's Hospital, Houston
Baylor College of Medicine
OTHER
Michael A Belfort
OTHER