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N/A Completed N=90 Randomized Diagnostic

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

Bladder Cancer
Source: ClinicalTrials.gov NCT01567462 ↗
Enrolled (actual)
90
Serious AEs
6.7%
Results posted
Dec 2017
Primary outcomePrimary: Number of Procedural Complications — 23; 15 complications

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Procedural Complications		 23; 15 —
SECONDARY
Mean Operative Time		 46.0; 56.4 —
SECONDARY
Mean Catheterization Time		 46.7; 45.9 —
SECONDARY
Number of Participants With Disease Recurrence		 8; 5 —

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01567462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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