Bladder CancerNCT00802633
Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?
A study testing Stapling device during radical cystectomy and Ligasure tissue sealing device in people with Bladder Cancer and Hemostasis, run by Vanderbilt University at 1 site in United States.
Trial summary
Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Bladder Cancer, Hemostasis
- What is being tested?
- Stapling device during radical cystectomy and Ligasure tissue sealing device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Muscle invasive bladder cancer
- Male/Female gender
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.
- Conditions
- Bladder Cancer, Hemostasis
- Being tested
- Stapling device during radical cystectomy, Ligasure tissue sealing device
- Keywords
- Tissue sealing device, Articulating stapling device, Radical cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapling device during radical cystectomyDevice
Also called Ethicon articulating stapler
Hemostasis
Ligasure tissue sealing deviceDevice
Also called Tissue sealing device
Efficacy of tissue sealing device during hemostasis
| Study group | Role | What they receive |
|---|---|---|
| Stapling device | Active comparator | Efficacy of stapling device during radical cystectomy Receives: Device: Stapling device during radical cystectomy |
| Ligasure Device | Active comparator | Efficacy of ligasure tissue sealing device during radical cystectomy Receives: Device: Ligasure tissue sealing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Blood Loss
Measured: Perioperative
Secondary outcomes (1)
Operating Room Time in Minutes
Measured: Intraoperative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2011
- Study completionJun 2012
Why it stopped: Enrollment was stopped after eighty patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SChang, Vanderbilt University
- Investigators
- Sam S Chang, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802633
- Sponsor's protocol ID
- 081018
- Status last verified
- Dec 2013
- First submitted
- 3 Dec 2008
- Last updated
- 11 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?
- ClinicalTrials.gov ID
- NCT00802633
- Acronym / sponsor ID
- 081018
- Conditions
- Bladder Cancer, Hemostasis
- Keywords
- Tissue sealing device, Articulating stapling device, Radical cystectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was stopped after eighty patients were enrolled.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 11 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stapling device | Active comparator | Device: Stapling device during radical cystectomyEfficacy of stapling device during radical cystectomy |
| Ligasure Device | Active comparator | Device: Ligasure tissue sealing deviceEfficacy of ligasure tissue sealing device during radical cystectomy |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Muscle invasive bladder cancer
- Male/Female gender
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stapling device during radical cystectomyAlso: Ethicon articulating staplerHemostasis | Device | Stapling device |
| Ligasure tissue sealing deviceAlso: Tissue sealing deviceEfficacy of tissue sealing device during hemostasis | Device | Ligasure Device |
Primary outcome
Estimated Blood Loss
Time frame: Perioperative
1 secondary outcome
Operating Room Time in Minutes
Time frame: Intraoperative time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam S Chang, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stapling device during radical cystectomy and Ligasure tissue sealing device in people with Bladder Cancer and Hemostasis, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Blood Loss (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.