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Sponsored by: |
University of Illinois |
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Information provided by: | University of Illinois |
ClinicalTrials.gov Identifier: | NCT00565435 |
Since Chiari malformation is a common disease, many patients require surgical operation to relieve pressure from the back portion of the skull. The purpose of this research is to compare two different materials that are routinely used to repair the opening in the brain covering during the surgery on the back portion of the skull in patients with symptomatic Chiari Malformation. None of the materials used in this study nor any procedures are experimental.
Condition |
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Chiari Malformation Type I |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Duragen vs. Duraguard in Chiari Surgery |
Estimated Enrollment: | 100 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | December 2008 |
Subjects are randomly assigned to receive either Duragen or Duraguard and then followed for a period of three months after surgery for follow-up evaluation as part of their routine care. The research portion of the study involves subjects completing a quality of life questionnaire each month and the research team reviews each subject's chart for any post-surgical complications.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Subjects diagnosed with symptomatic Chiari I Malformation
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Department of Neurosurgery, Univ of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 |
Principal Investigator: | Konstantin Slavin, MD | Department of Neurosurgery , Univeristy of Illinois at Chicago |
Responsible Party: | Department of Neurosurgery ( Konstantin Slavin, MD ) |
Study ID Numbers: | 2002-0232 |
Study First Received: | November 29, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00565435 |
Health Authority: | United States: Institutional Review Board |
Chiari I Malformation |
Neural Tube Defects Arnold-Chiari Malformation Nervous System Malformations Estradiol 3-benzoate Estradiol valerate Arnold-Chiari malformation |
Neural tube defect, folate-sensitive Estradiol 17 beta-cypionate Polyestradiol phosphate Congenital Abnormalities Estradiol |
Nervous System Diseases |