Bladder Cancer Clinical Trial
— PK ButtonOfficial title:
PK Button Vaporization Electrode for Treatment of Bladder Tumors
Verified date | October 2017 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the use of two types of equipment during transurethral resection of bladder tumors (TURBT). The two types of surgical devices are: the monopolar loop electrocautery and the PlasmaKinetic (PK) Button Vaporization Electrode. These two devices do the same task but differ in the way they create electric current when removing cancerous tissue. The investigators hope to examine and compare the uses of these two surgical devices to see if any advantages do exist or whether they actually are similar. The goal of the study is to prove similarity in outcomes between the two techniques and analyze the outcomes resulting from each case.
Status | Completed |
Enrollment | 95 |
Est. completion date | March 28, 2017 |
Est. primary completion date | March 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: - Patients with cystoscopically detected bladder tumors requiring TURBT - Patients with bladder tumors which are endoscopically resectable by surgeon's judgment with only one trip into the operating room. Exclusion Criteria: - Patients with clinical evidence of locally advanced, nodal, or metastatic bladder cancer - Patients with hydronephrosis secondary to bladder cancer - Patients with diffuse tumor throughout bladder that is deemed unresectable by surgeon |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Department of Urology | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Olympus |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Procedural Complications | The number of procedural complications describes the total number of post-operative bleeding, need for blood transfusion, bladder perforation, obturator nerve stimulation, catheterization time, or need for hospitalization or bladder irrigation events that occur within thirty days of the procedure. | Post-Intervention (Up to 30 Days) | |
Secondary | Mean Operative Time | The average operative time was measured through study completion. | After Surgery Completion, Up to 174 Minutes | |
Secondary | Mean Catheterization Time | The average duration of the catheterization time was measured through study completion. | After Surgery Completion, Up to 336 Hours | |
Secondary | Number of Participants With Disease Recurrence | The number of participants who had disease recurrence within the four month follow up period. | Post-Intervention (Up to 4 Months) |
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