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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00768703 |
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.
Condition | Intervention | Phase |
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Severe Congenital Diaphragmatic Hernia |
Device: Percutaneous endoscopic fetal tracheal occlusion/unocclusion |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Percutaneous Endoscopic Tracheal Plug/Unplug for Congenital Diaphragmatic Hernia |
Estimated Enrollment: | 10 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment: Experimental
Percutaneous endoscopic fetal tracheal 'plug/unplug' using the Goldvalve balloon
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
General subject population: Pregnant women in the second trimester, at least 18 years of age, and of any and all ethnic backgrounds.
Inclusion Criteria:
Exclusion Criteria:
Contact: Jody A Farrell, MSN, PNP | 4154760445 | fetus@ucsfmedctr.org |
Contact: Tamara Ryan, ADN | 4154760445 | fetus@ucsfmedctr.org |
United States, California | |
University of California, San Francisco Fetal Treatment Center | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Jody A. Farrell, MSN, PNP 800-793-3887 fetus@ucsfmedctr.org | |
Contact: Tamara Ryan, RN 1-800-793-3887 fetus@ucsfmedctr.org | |
Principal Investigator: Hanmin Lee, MD | |
Sub-Investigator: Larry Rand, MD | |
Sub-Investigator: Linda Hopkins, MD | |
Sub-Investigator: Ruth B Goldstein, MD | |
Sub-Investigator: Roberta L Keller, MD | |
Sub-Investigator: Shinjiro Hirose, MD | |
Sub-Investigator: Kerilyn K Nobuhara, MD | |
Sub-Investigator: Barbara J Bratton, MSN, PNP |
Principal Investigator: | Hanmin Lee, MD | University of California, San Francisco Fetal Treatment Center |
Responsible Party: | University of California, San Francisco ( Hanmin Lee, MD ) |
Study ID Numbers: | H11258-32532 |
Study First Received: | October 6, 2008 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00768703 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United States: UCSF Fetal Surgery Oversight Committee |
Congenital diaphragmatic hernia lung-head ratio percutaneous tracheal occlusion fetal intervention |
Pathological Conditions, Anatomical Congenital diaphragmatic hernia Hernia Hernia, Diaphragmatic |