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

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ClinicalTrials.gov Identifier: NCT00768703
Expanded Access Status : No longer available
First Posted : October 8, 2008
Last Update Posted : March 27, 2019
Information provided by (Responsible Party):
Hanmin Lee, University of California, San Francisco

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.

Condition or disease Intervention/treatment
Severe Congenital Diaphragmatic Hernia Device: Percutaneous endoscopic fetal tracheal occlusion/unocclusion

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: Percutaneous Endoscopic Tracheal Plug/Unplug for Congenital Diaphragmatic Hernia

Intervention Details:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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:

  • Confirmed diagnosis of CDH
  • Normal fetal echocardiogram
  • Normal karyotype
  • Fetal liver herniated into the left hemithorax
  • Lung-head ratio (LHR) is 1.0 or less, calculated between 24-26 weeks' gestation
  • Fetus is between 26 and 28 weeks' gestation
  • Singleton pregnancy
  • Mother meets psychosocial criteria
  • Pre-authorization from third-party payor for fetal intervention, or ability to self-pay.

Exclusion Criteria:

  • Failure to meet all inclusion criteria
  • Other congenital anomalies detected on ultrasound
  • Contraindication to abdominal surgery or general anesthesia
  • Allergy to latex
  • Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor)
  • Family unable or refuses to stay in San Francisco for duration of the tracheal occlusion period and for the duration of the pregnancy as medically necessary.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768703

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United States, California
University of California, San Francisco Fetal Treatment Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Hanmin Lee, MD University of California, San Francisco Fetal Treatment Center
Additional Information:

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Responsible Party: Hanmin Lee, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00768703    
Other Study ID Numbers: 10-01765
TO CDH ( Other Identifier: UCSF(University of California, San Francisco) Fetal Treatment Center )
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Keywords provided by Hanmin Lee, University of California, San Francisco:
Congenital diaphragmatic hernia
lung-head ratio
percutaneous tracheal occlusion
fetal intervention
Additional relevant MeSH terms:
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Hernias, Diaphragmatic, Congenital
Hernia, Diaphragmatic
Pathological Conditions, Anatomical
Internal Hernia
Congenital Abnormalities