Clinical Trial: Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)

Brief Summary: The goal is to study the feasibility and safety of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia (CDH). The pilot study will determine whether FETO therapy can be performed safely and whether it can increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe left CDH.

Detailed Summary:
Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: November 2, 2015
Date Started: December 2015
Date Completion: December 2018
Last Updated: May 3, 2017
Last Verified: May 2017