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Percutaneous Endoscopic Tracheal Plug/Unplug for CDH (Congenital Diaphragmatic Hernia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00768703
Expanded Access Status : No longer available
First Posted : October 8, 2008
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Hanmin Lee, University of California, San Francisco

Tracking Information
First Submitted Date October 6, 2008
First Posted Date October 8, 2008
Last Update Posted Date March 27, 2019
 
Descriptive Information
Brief Title Percutaneous Endoscopic Tracheal Plug/Unplug for CDH (Congenital Diaphragmatic Hernia)
Brief Summary Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm. Herniation of viscera into the chest prevents the fetal lungs from developing and growing to normal size. In the most severe cases, there is significant morbidity and mortality at birth. For these fetuses, fetal intervention may improve outcomes by enabling the lungs to grow enough in utero that they are capable of sustaining life after birth. This unblinded, non-randomized trial will assess the safety and efficacy of the use of the Goldvalve balloon and MiniTorquer microcatheter to perform percutaneous temporary tracheal occlusion to treat severe CDH in utero. The primary outcome variable will be fetal lung growth due to successful 'plugging/unplugging' of the trachea, as determined by serial lung-head ratio (LHR) measurements. Secondary outcome variables include maternal, fetal and neonatal variables, specifically neonatal survival at 90 days of life. For infants who survive beyond 90 days post-delivery, their families will be offered follow-up (up to 2 years of age and possibly beyond) in the Long-term Infant-to-Adult Follow-up Evaluation (LIFE) Clinic at UCSF.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Treatment IND/Protocol
Intervention Device: Percutaneous endoscopic fetal tracheal occlusion/unocclusion
Between 26-28 wks' gestation, percutaneous endoscopic placement of the tracheal balloon. Between 32-34 wks' gestation, percutaneous endoscopic removal of the balloon.
Other Name: Goldvalve Balloon and MiniTorquer Delivery Microcatheter
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00768703
Responsible Party Hanmin Lee, University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: Hanmin Lee, MD University of California, San Francisco Fetal Treatment Center
PRS Account University of California, San Francisco
Verification Date March 2019