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

NCT01567462 | Completed Results DMC

• 2 other identifiers: IRB00053735PK Button and Bladder Tumors
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

bladder cancer; transurethral resection of bladder tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean Operative Time

  After Surgery Completion, Up to 174 Minutes

• Mean Catheterization Time

  After Surgery Completion, Up to 336 Hours

• Number of Participants With Disease Recurrence

  Post-Intervention (Up to 4 Months)

Study Arms (2)

Monopolar Electrocautery

ACTIVE COMPARATOR

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.

Device: Monopolar electrocautery loop in Transurethral resection of bladder tumors

PK Button Vaporization Electrode

ACTIVE COMPARATOR

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.

Device: PK Button Vaporization Electrode in transurethral resection of bladder tumors

Interventions

Monopolar electrocautery loop in Transurethral resection of bladder tumors DEVICE

Standard monopolar electrocautery loop in transurethral resection of bladder tumors (TURBT)

Monopolar Electrocautery

PK Button Vaporization Electrode in transurethral resection of bladder tumors DEVICE

PlasmaKinetic (PK) Button Vaporization Electrode in transurethral resection of bladder tumors (TURBT)

PK Button Vaporization Electrode

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Olympus: collaborator

Study Sites (1)

Emory University Department of Urology

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Kenneth Ogan
• Organization: Emory University

kogan@emory.edu

404-778-3038

Study Officials

• Kenneth Ogan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 30, 2012
• Study Start: September 1, 2012
• Primary Completion: March 28, 2017
• Study Completion: March 28, 2017
• Last Updated: December 8, 2017
• Results First Posted: December 8, 2017

Record last verified: 2017-10

Locations

US (1)