PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors

This study is currently recruiting participants.
Verified September 2013 by Emory University
Sponsor:
Collaborator:
Olympus
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01567462
First received: March 27, 2012
Last updated: September 23, 2013
Last verified: September 2013

March 27, 2012
September 23, 2013
December 2012
August 2014   (final data collection date for primary outcome measure)
Procedural complications [ Time Frame: within 30 days of procedure ] [ Designated as safety issue: No ]
The primary endpoint will be the measurements of procedural complications, which include post-operative bleeding, need for blood transfusion, bladder perforation, obturator nerve stimulation, catheterization time, or need for hospitalization or bladder irrigation. The expected rate of composite complications is 10-15%. If one or more of the aforementioned complications occur, then the case will be recorded to have a complication.
Same as current
Complete list of historical versions of study NCT01567462 on ClinicalTrials.gov Archive Site
  • Operative follow-up [ Time Frame: Patients will be followed on average for 4 months following the procedure. Actual dates will coincide with when they can schedule their post-operative visits. ] [ Designated as safety issue: No ]
    One secondary endpoint will be the assessment of the length of operative time.
  • Operative follow-up [ Time Frame: Patients will be followed on average for 4 months following the procedure. Actual dates will coincide with when they can schedule their post-operative visits. ] [ Designated as safety issue: No ]
    One secondary endpoint will be the assessment of whether there is tumor recurrence following the procedure.
  • Operative follow-up [ Time Frame: Patients will be followed on average for 4 months following procedure. Actual dates will coincide with when they can schedule their post-operative visits. ] [ Designated as safety issue: No ]
    One secondary endpoint will be the assessment of the amount of thermal spread or cautery artifact in biopsies of tumor base.
Same as current
Not Provided
Not Provided
 
PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors
PK Button Vaporization Electrode for Treatment of Bladder Tumors

The purpose of this study is to compare the uses 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 will be to prove similarity in outcomes between the two techniques and analyze the outcomes resulting from each case.

This study will study the medical intervention used when bladder cancer patients present with a new or recurrent bladder tumor. Currently when patients report these tumors, they undergo a standard practice called transurethral resection of the bladder tumor (TURBT) in order to determine the stage of the cancer. This intervention, accomplished by looking through the urethra using an endoscope, is both diagnostic and potentially therapeutic. An adequately performed TURBT will provide the pathologist with enough tissue to provide tumor grade and stage information. Currently, TURBT is done using equipment called monopolar electrocautery which is in the form a 90-degree loop electrode. Although usually safe and sufficient, this technique can create technical challenges because it can be difficult to position the loop electrode in a dynamically changing cylindrical space (the bladder). Specifically, especially with larger bladder tumors, intraoperative bleeding can obscure visualization and result in incomplete tumor resection as well as inadequate sampling of the layers of the bladder needed to establish tumor stage. Furthermore, monopolar current can result in stimulation of a nerve (the obturator nerve) during resection of wall tumors, resulting in violent movement of the leg which can cause a potential bladder tear as well as possible (iliac) vessel injury.

Conversely, a technique using bipolar energy, which has been available for many years, has been readily adopted for the surgical treatment of benign prostatic enlargement. The advantages of a bipolar electrical current include the direct return of electrical current to the loop rather than to a grounding pad placed on the patient's skin. This has the theoretical value of limiting the diffusion of electrical current, and therefore heat, to the surrounding tissue. A further refinement on bipolar energy has been the recent introduction of a piece of equipment called the PlasmaKinetic (PK) Button Vaporization electrode, which is currently approved by the Food and Drug Administration (FDA) for this indication. Coupling bipolar energy into the Button electrode would not only harness the benefits of less thermal spread but also would obviate the geometric challenges associated with loop electrodes during resection of bladder tumors. Procedural advantages would potentially include minimal bleeding, good visualization, and a reduction in the occurrence of the obturator reflex and concomitant bladder perforation.

This study is a randomized double-arm trial examining the results of both techniques for bladder cancer TURBT procedures with a minimum of 120 patients at Emory. The purpose of this study is to measure the procedural (intraoperative), short term, as clinically indicated (4-6 weeks), and long-term (3 months) outcomes of TURBT using the PK Button when compared to traditional monopolar loop electrocautery. The goal of the study will be to prove equivalence in outcomes between the two techniques.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Bladder Cancer
  • Device: Monopolar electrocautery loop in Transurethral resection of bladder tumors
    Standard monopolar electrocautery loop in transurethral resection of bladder tumors (TURBT)
  • Device: PK Button Vaporization Electrode in transurethral resection of bladder tumors
    PlasmaKinetic (PK) Button Vaporization Electrode in transurethral resection of bladder tumors (TURBT)
  • Active Comparator: Monopolar Electrocautery
    The current treatment standard of care for patients who present de novo or with a recurrent bladder tumor is transurethral resection of the bladder tumor (TURBT) using monopolar electrocautery in the form a 90-degree loop electrode and has been used since its introduction in 1952. This intervention, accomplished endoscopically through the urethra, is both diagnostic and potentially therapeutic. An adequately performed TURBT will provide the pathologist with enough tissue to provide tumor grade and stage information.
    Intervention: Device: Monopolar electrocautery loop in Transurethral resection of bladder tumors
  • Active Comparator: PK Button Vaporization Electrode
    Bipolar energy has been available for many years and has been readily adopted for the surgical treatment of benign prostatic enlargement and may provide advantages and solutions to the technical challenges of monopolar electrocautery. A further refinement on bipolar energy has been the recent introduction of the PlasmaKinetic (PK) Button Vaporization electrode which will be used in the intervention arm of this study. This electrode is already approved by the Food and Drug Administration (FDA) for this indication as well. The semi-spherical design of the electrode creates a plasma arc that glides over the tissue, transmitting energy to the cell layers adjacent to the arc which are then quickly vaporized.
    Intervention: Device: PK Button Vaporization Electrode in transurethral resection of bladder tumors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 89 Years
No
Contact: Kenneth Ogan, MD 404-778-4898 kogan@emory.edu
Contact: Lane Ringer, BS 404-778-4162 eringer@emory.edu
United States
 
NCT01567462
IRB00053735, PK Button and Bladder Tumors
Yes
Kenneth Ogan, MD, Emory University
Emory University
Olympus
Principal Investigator: Daniel Canter, MD Emory University
Emory University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP