Back to resultsRadical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?
Primary Purpose
Bladder Cancer, Hemostasis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stapling device during radical cystectomy
Ligasure tissue sealing device
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring Tissue sealing device, Articulating stapling device, Radical cystectomy
Eligibility Criteria
Inclusion Criteria:
- Muscle invasive bladder cancer
- Male/Female gender
Exclusion Criteria:
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Stapling device
Ligasure Device
Arm Description
Efficacy of stapling device during radical cystectomy
Efficacy of ligasure tissue sealing device during radical cystectomy
Outcomes
Primary Outcome Measures
Estimated Blood Loss
Secondary Outcome Measures
Operating Room Time in Minutes
Full Information
NCT ID
NCT00802633
First Posted
December 3, 2008
Last Updated
December 21, 2013
Sponsor
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT00802633
Brief Title
Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?
Official Title
Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was stopped after eighty patients were enrolled.
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Hemostasis
Keywords
Tissue sealing device, Articulating stapling device, Radical cystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stapling device
Arm Type
Active Comparator
Arm Description
Efficacy of stapling device during radical cystectomy
Arm Title
Ligasure Device
Arm Type
Active Comparator
Arm Description
Efficacy of ligasure tissue sealing device during radical cystectomy
Intervention Type
Device
Intervention Name(s)
Stapling device during radical cystectomy
Other Intervention Name(s)
Ethicon articulating stapler
Intervention Description
Hemostasis
Intervention Type
Device
Intervention Name(s)
Ligasure tissue sealing device
Other Intervention Name(s)
Tissue sealing device
Intervention Description
Efficacy of tissue sealing device during hemostasis
Primary Outcome Measure Information:
Title
Estimated Blood Loss
Time Frame
Perioperative
Secondary Outcome Measure Information:
Title
Operating Room Time in Minutes
Time Frame
Intraoperative time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Muscle invasive bladder cancer
Male/Female gender
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam S Chang, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?
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