Trial Outcomes & Findings for Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery (NCT NCT00952315)

NCT ID: NCT00952315

Last Updated: 2019-07-05

Results Overview

Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 270 participants
• Primary outcome timeframe: collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket
• Results posted on: 2019-07-05

Participant Flow

Participant milestones

Measure	Stonebreaker Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Overall Study STARTED	90	90	90
Overall Study COMPLETED	64	66	71
Overall Study NOT COMPLETED	26	24	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Stonebreaker n=64 Participants Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 Participants Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 Participants The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.	Total n=201 Participants Total of all reporting groups
Age, Continuous	55.2 years n=64 Participants	58.1 years n=66 Participants	57.4 years n=71 Participants	57 years n=201 Participants
Sex: Female, Male Female	32 Participants n=64 Participants	34 Participants n=66 Participants	36 Participants n=71 Participants	102 Participants n=201 Participants
Sex: Female, Male Male	32 Participants n=64 Participants	32 Participants n=66 Participants	35 Participants n=71 Participants	99 Participants n=201 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment North America	64 participants n=64 Participants	66 participants n=66 Participants	71 participants n=71 Participants	201 participants n=201 Participants

PRIMARY outcome

Timeframe: collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket

Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)

Outcome measures

Measure	Stonebreaker n=64 Participants Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 Participants Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 Participants The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Stone Clearance Time in mm2/Min	24.0 mm^2/min Standard Deviation 13.9	28.9 mm^2/min Standard Deviation 16.2	32.3 mm^2/min Standard Deviation 23.4

SECONDARY outcome

Timeframe: Post-operative Day 1

Number of participants deemed stone-free after initial stone-removal surgery

Outcome measures

Measure	Stonebreaker n=64 Participants Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 Participants Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 Participants The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Stone-free After First Procedure	33 Participants	43 Participants	39 Participants

SECONDARY outcome

Timeframe: Within three days of initial procedure

Number of participants who required a secondary kidney stone removal procedure

Outcome measures

Measure	Stonebreaker n=64 Participants Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 Participants Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 Participants The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Secondary Procedure Required	15 Participants	16 Participants	24 Participants

SECONDARY outcome

Timeframe: Intra-operatively

Participants requiring a ureteral stent to be placed after initial stone removal procedure

Outcome measures

Measure	Stonebreaker n=64 Participants Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 Participants Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 Participants The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Ureteral Stent Placed	3 Participants	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Intra-operatively

Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure

Outcome measures

Measure	Stonebreaker n=64 Participants Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 Participants Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 Participants The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Nephrostomy Tube Placed	55 Participants	59 Participants	63 Participants

SECONDARY outcome

Timeframe: Intra-operatively

Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite

Outcome measures

Measure	Stonebreaker n=64 Participants Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 Participants Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 Participants The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Use of Other Device	8 Participants	9 Participants	5 Participants

SECONDARY outcome

Timeframe: Intra-operatively

Number of participants with an estimated blood loss greater than 400mL

Outcome measures

Measure	Stonebreaker n=64 Participants Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 Participants Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 Participants The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
EBL>400mL	4 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Post-operatively <24 hours

Number of participants who required a blood transfusion post-operatively

Outcome measures

Measure	Stonebreaker n=64 Participants Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 Participants Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 Participants The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
RBC Transfusion	3 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Post-operatively

Number of days participants were in hospital. Operative day is Day 1.

Outcome measures

Measure	Stonebreaker n=64 Participants Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 Participants Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 Participants The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Length of Stay	1.9 Days Standard Deviation 1.5	2.5 Days Standard Deviation 2.1	2.6 Days Standard Deviation 2.5

SECONDARY outcome

Timeframe: Post-operative Days 2 and 3

Number of participants who experienced surgery-related post-op complications

Outcome measures

Measure	Stonebreaker n=64 Participants Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 Participants Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 Participants The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Post-operative Complications	10 Participants	10 Participants	11 Participants

Adverse Events

Stonebreaker

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Lithoclast Select

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Cyberwand

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Stonebreaker n=64 participants at risk Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Stonebreaker: Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select n=66 participants at risk Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Lithoclast Select: Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented	Cyberwand n=71 participants at risk The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Cyberwand: Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Renal and urinary disorders Use of another stone breakage device intraoperatively	12.5% 8/64 • 3 months	13.6% 9/66 • 3 months	7.0% 5/71 • 3 months
Surgical and medical procedures Post-operative Complications	15.6% 10/64 • 3 months	15.2% 10/66 • 3 months	15.5% 11/71 • 3 months

Additional Information

James Lingeman, MD

IU Health Physicians Urology

Phone: 317-962-3700

Results disclosure agreements

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