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Percutaneous Endoscopic Tracheal Plug/Unplug for CDH
This study is currently recruiting participants.
Verified by University of California, San Francisco, June 2008
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00768703
  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 I
Phase II

MedlinePlus related topics: Endoscopy Hernia
U.S. FDA Resources
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

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 2012
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment: Experimental
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.

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

Contacts
Contact: Jody A Farrell, MSN, PNP 4154760445 fetus@ucsfmedctr.org
Contact: Tamara Ryan, ADN 4154760445 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     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            
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Hanmin Lee, MD University of California, San Francisco Fetal Treatment Center
  More Information

UCSF Fetal Treatment Center  This link exits the ClinicalTrials.gov site
"Inside": UCSF Fetal Treatment Center Online Patient Program  This link exits the ClinicalTrials.gov site

Publications:
Jani JC, Nicolaides KH, Gratacós E, Vandecruys H, Deprest JA; FETO Task Group. Fetal lung-to-head ratio in the prediction of survival in severe left-sided diaphragmatic hernia treated by fetal endoscopic tracheal occlusion (FETO). Am J Obstet Gynecol. 2006 Dec;195(6):1646-50. Epub 2006 Jun 12.
Doné E, Gucciardo L, Van Mieghem T, Jani J, Cannie M, Van Schoubroeck D, Devlieger R, Catte LD, Klaritsch P, Mayer S, Beck V, Debeer A, Gratacos E, Nicolaides K, Deprest J. Prenatal diagnosis, prediction of outcome and in utero therapy of isolated congenital diaphragmatic hernia. Prenat Diagn. 2008 Jul;28(7):581-91.
Cortes RA, Keller RL, Townsend T, Harrison MR, Farmer DL, Lee H, Piecuch RE, Leonard CH, Hetherton M, Bisgaard R, Nobuhara KK. Survival of severe congenital diaphragmatic hernia has morbid consequences. J Pediatr Surg. 2005 Jan;40(1):36-45; discussion 45-6.
Keller RL, Hawgood S, Neuhaus JM, Farmer DL, Lee H, Albanese CT, Harrison MR, Kitterman JA. Infant pulmonary function in a randomized trial of fetal tracheal occlusion for severe congenital diaphragmatic hernia. Pediatr Res. 2004 Nov;56(5):818-25. Epub 2004 Aug 19.
Harrison MR, Keller RL, Hawgood SB, Kitterman JA, Sandberg PL, Farmer DL, Lee H, Filly RA, Farrell JA, Albanese CT. A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. N Engl J Med. 2003 Nov 13;349(20):1916-24.
Harrison MR, Albanese CT, Hawgood SB, Farmer DL, Farrell JA, Sandberg PL, Filly RA. Fetoscopic temporary tracheal occlusion by means of detachable balloon for congenital diaphragmatic hernia. Am J Obstet Gynecol. 2001 Sep;185(3):730-3.

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

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

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Congenital diaphragmatic hernia
Hernia
Hernia, Diaphragmatic

ClinicalTrials.gov processed this record on January 15, 2009