Clinical Trial: Pilot Trial FETO for CDH
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Pilot Trial of Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) at Mayo Clinic
Brief Summary:
Subjects to be enrolled in this study are pregnant women whose unborn baby has been diagnosed with severe congenital diaphragmatic hernia (CDH). CDH is a birth defect occurring early in pregnancy. It is characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other organs in the baby's abdomen can move into the chest and press on the developing lungs. CDH is a serious condition which prevents the fetal lungs from developing normally.
The purpose of this study is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO). FETO involves two surgical procedures while the mother is still pregnant. During the early third trimester of pregnancy, a special tiny balloon is placed in the baby's trachea. After the balloon has been in place for several weeks, the balloon will be removed during a second procedure, generally done when the baby has reached about 34 weeks gestation.
The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe CDH. If better lung development can be promoted, it is expected that overall survival of babies with severe CDH after birth will also be improved.
Detailed Summary:
Sponsor: Rodrigo Ruano M.D., Ph.D
Current Primary Outcome: Number of successfully completed surgical procedures [ Time Frame: approximately 4 hours after initiation of the surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Mayo Clinic
Dates:
Date Received: May 1, 2017
Date Started: May 8, 2017
Date Completion: March 31, 2019
Last Updated: May 8, 2017
Last Verified: May 2017
