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Percutaneous Endoscopic Tracheal Plug/Unplug for CDH

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Hanmin Lee, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00768703
First received: October 6, 2008
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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
Severe Congenital Diaphragmatic Hernia
Device: Percutaneous endoscopic fetal tracheal occlusion/unocclusion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Endoscopic Tracheal Plug/Unplug for Congenital Diaphragmatic Hernia

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Fetal lung growth due to successful fetal tracheal occlusion/unocclusion, as determined by serial LHR measurements [ Time Frame: Between 26 and 34 weeks gestation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Neonatal survival at 90 days of life. [ Time Frame: 90 days post-delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Percutaneous endoscopic fetal tracheal 'plug/unplug' using the Goldvalve balloon
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768703

Contacts
Contact: Jody A Farrell, MSN, PNP 415 476 0445 fetus@ucsfmedctr.org
Contact: Tamara Ryan, ADN 415 502 0173 fetus@ucsfmedctr.org

Locations
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    415-502-0173    fetus@ucsfmedctr.org   
Principal Investigator: Hanmin Lee, MD         
Sub-Investigator: Larry Rand, MD         
Sub-Investigator: Ruth B Goldstein, MD         
Sub-Investigator: Roberta L Keller, MD         
Sub-Investigator: Barbara J Bratton, MSN, PNP         
Sub-Investigator: Lan T Vu, MD         
Sub-Investigator: Benjamin Padilla, MD         
Sub-Investigator: Maura O'Day, MSN, PNP         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Hanmin Lee, MD University of California, San Francisco Fetal Treatment Center
  More Information

Additional Information:
Publications:

Responsible Party: Hanmin Lee, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00768703     History of Changes
Other Study ID Numbers: 10-01765, TO CDH
Study First Received: October 6, 2008
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: UCSF Fetal Surgery Oversight Committee

Keywords provided by University of California, San Francisco:
Congenital diaphragmatic hernia
lung-head ratio
percutaneous tracheal occlusion
fetal intervention

Additional relevant MeSH terms:
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 20, 2014