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Sponsored by: |
Vanderbilt University |
---|---|
Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00802633 |
Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.
Condition | Intervention |
---|---|
Bladder Cancer Hemostasis |
Device: Stapling device during radical cystectomy Device: Ligasure tissue sealing device |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device? |
Enrollment: | 20 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Stapling device
|
Device: Stapling device during radical cystectomy
Hemostasis
|
2: Experimental
Efficacy of ligasure tissue sealing device during radical cystectomy
|
Device: Ligasure tissue sealing device
Efficacy of tissue sealing device during hemostasis
|
Ages Eligible for Study: | 19 Years to 85 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Vanderbilt University Medical Center ( Carl Bischoff, MD ) |
Study ID Numbers: | 081018 |
Study First Received: | December 3, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00802633 History of Changes |
Health Authority: | United States: Institutional Review Board |
Tissue sealing device Articulating stapling device Radical cystectomy |
Urinary Tract Neoplasm Cystocele Urologic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms |
Urogenital Neoplasms Bladder Neoplasm Urologic Neoplasms Hemostatics |
Neoplasms Neoplasms by Site Urologic Diseases Urinary Bladder Diseases |
Urinary Bladder Neoplasms Urogenital Neoplasms Urologic Neoplasms |