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NCT00802633 Clinical Trial

Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?

Bladder Cancer Clinical Trial

Official title:
Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00802633
Other study ID # 081018
Secondary ID
Status Terminated
Phase N/A
First received December 3, 2008
Last updated December 21, 2013
Start date November 2008
Est. completion date June 2012

Study information
Verified date December 2013
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.

Recruitment information / eligibility
Status Terminated
Enrollment 80
Est. completion date June 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 85 Years
Eligibility Inclusion Criteria:

- Muscle invasive bladder cancer

- Male/Female gender

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Stapling device during radical cystectomy
Hemostasis
• Ligasure tissue sealing device
Efficacy of tissue sealing device during hemostasis

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Estimated Blood Loss Perioperative Yes
Secondary Operating Room Time in Minutes Intraoperative time No
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