Trial Outcomes & Findings for PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors (NCT NCT01567462)

NCT ID: NCT01567462

Last Updated: 2017-12-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 95 participants
• Primary outcome timeframe: Post-Intervention (Up to 30 Days)
• Results posted on: 2017-12-08

Participant Flow

Participants were recruited between September 2012 and March 2017. Of the 95 participants who signed consent, 90 subjects began study participation.

Participant milestones

Measure	Monopolar Loop Electrocautery Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.	PK Button Vaporization Electrode Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
Overall Study STARTED	45	45
Overall Study COMPLETED	41	38
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Measure	Monopolar Loop Electrocautery Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.	PK Button Vaporization Electrode Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
Overall Study Withdrawal by Subject	4	7

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Monopolar Loop Electrocautery n=41 Participants Participants completed a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery and all follow up procedures.	PK Button Vaporization Electrode n=38 Participants Participants completed a transurethral resection of a bladder tumor using a PK button vaporization electrode and all follow up procedures.	Total n=79 Participants Total of all reporting groups
Age, Continuous	68.7 years STANDARD_DEVIATION 12.2 • n=5 Participants	69.2 years STANDARD_DEVIATION 11.4 • n=7 Participants	69 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized White	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Race/Ethnicity, Customized Non-White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Unreported	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post-Intervention (Up to 30 Days)

Population: Participants who completed all study procedures per protocol.

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.

Outcome measures

Measure	Monopolar Loop Electrocautery n=41 Participants Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.	PK Button Vaporization Electrode n=38 Participants Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
Number of Procedural Complications	23 complications	15 complications

SECONDARY outcome

Timeframe: After Surgery Completion, Up to 174 Minutes

Population: Participants who completed all study procedures per protocol.

The average operative time was measured through study completion.

Outcome measures

Measure	Monopolar Loop Electrocautery n=41 Participants Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.	PK Button Vaporization Electrode n=38 Participants Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
Mean Operative Time	46.0 minutes Standard Deviation 28.7	56.4 minutes Standard Deviation 35.4

SECONDARY outcome

Timeframe: After Surgery Completion, Up to 336 Hours

Population: Participants who required catheterization after the operative procedure.

The average duration of the catheterization time was measured through study completion.

Outcome measures

Measure	Monopolar Loop Electrocautery n=40 Participants Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.	PK Button Vaporization Electrode n=35 Participants Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
Mean Catheterization Time	46.7 hours Standard Deviation 74.9	45.9 hours Standard Deviation 72.9

SECONDARY outcome

Timeframe: Post-Intervention (Up to 4 Months)

Population: Participants who completed all study procedures per protocol.

The number of participants who had disease recurrence within the four month follow up period.

Outcome measures

Measure	Monopolar Loop Electrocautery n=41 Participants Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.	PK Button Vaporization Electrode n=38 Participants Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
Number of Participants With Disease Recurrence	8 participants	5 participants

Adverse Events

Monopolar Loop Electrocautery

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

PK Button Vaporization Electrode

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Monopolar Loop Electrocautery n=45 participants at risk Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.	PK Button Vaporization Electrode n=45 participants at risk Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
Injury, poisoning and procedural complications Postoperative Bleeding	4.4% 2/45 • Number of events 3 • Adverse events were collected throughout the duration of the study (5 years).	2.2% 1/45 • Number of events 1 • Adverse events were collected throughout the duration of the study (5 years).
Renal and urinary disorders Bladder Perforation	11.1% 5/45 • Number of events 5 • Adverse events were collected throughout the duration of the study (5 years).	0.00% 0/45 • Adverse events were collected throughout the duration of the study (5 years).
Respiratory, thoracic and mediastinal disorders Respiratory Distress Syndrome	2.2% 1/45 • Number of events 1 • Adverse events were collected throughout the duration of the study (5 years).	0.00% 0/45 • Adverse events were collected throughout the duration of the study (5 years).

Other adverse events

Measure	Monopolar Loop Electrocautery n=45 participants at risk Participants underwent a transurethral resection of the bladder tumor (TURBT) using monopolar loop electrocautery.	PK Button Vaporization Electrode n=45 participants at risk Participants underwent a transurethral resection of a bladder tumor using a PK button vaporization electrode.
Injury, poisoning and procedural complications Continuous Bladder Irrigation	24.4% 11/45 • Number of events 11 • Adverse events were collected throughout the duration of the study (5 years).	8.9% 4/45 • Number of events 4 • Adverse events were collected throughout the duration of the study (5 years).

Additional Information

Dr. Kenneth Ogan

Emory University

Phone: 404-778-3038

Email: kogan@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place