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Enrollment was stopped after eighty patients were enrolled.
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Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stapling device | Active Comparator | Efficacy of stapling device during radical cystectomy |
|
| Ligasure Device | Active Comparator | Efficacy of ligasure tissue sealing device during radical cystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stapling device during radical cystectomy | Device | Hemostasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss | Perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Operating Room Time in Minutes | Intraoperative time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam S Chang, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stapling Device | Efficacy of stapling device during radical cystectomy Stapling device during radical cystectomy: Hemostasis |
| FG001 | Ligasure Device | Efficacy of ligasure tissue sealing device during radical cystectomy Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stapling Device | Efficacy of stapling device during radical cystectomy Stapling device during radical cystectomy: Hemostasis |
| BG001 | Ligasure Device | Efficacy of ligasure tissue sealing device during radical cystectomy Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Estimated Blood Loss | Posted | Mean | Standard Deviation | milliliters | Perioperative |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stapling Device | Efficacy of stapling device during radical cystectomy Stapling device during radical cystectomy: Hemostasis |
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Study terminated after 80 subjects
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sam Chang | Vanderbilt University | 615-322-2101 | sam.chang@Vanderbilt.Edu |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Ligasure tissue sealing device | Device | Efficacy of tissue sealing device during hemostasis |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
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| Secondary | Operating Room Time in Minutes | Posted | Mean | Standard Deviation | minutes | Intraoperative time |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Ligasure Device | Efficacy of ligasure tissue sealing device during radical cystectomy Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis | 0 | 40 | 0 | 40 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |