Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery

• Sponsor: Indiana Kidney Stone Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00952315
• Collaborator: (none)
• Enrollment: 270
• Locations: 10
• Arms: 3
• Duration (Months): 90.1
• Patients Per Site: 27
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stones	Device: Cyberwand; Device: Stonebreaker; Device: Lithoclast Select	N/A

Detailed Description

Large kidney stones can be removed by a surgical procedure where a small puncture is made through the back into the kidney (percutaneous nephrolithotomy or PNL) but the stones usually need to be broken into smaller pieces before they can be removed through the small surgical incision. There are a number of FDA approved devices commercially available used to break up the stones including pneumatic, ultrasonic, and a combination of the two. Each technology has advantages and disadvantages.

In the last few years there have been new, improved versions of these devices introduced. These improved versions have addressed previous issues of probes clogging or breaking and cumbersome handpiece design. These include the Cyberwand (Cybersonics, Erie, PA), a dual probe ultrasonic device, Swiss Lithoclast Select (EMS, Switzerland) combining the pneumatic and ultrasonic modalities, and a novel device by LMA (Gland, Switzerland) called the StoneBreakerTM, a portable pneumatic device powered by CO2 cartridges.

We propose to compare each of these devices in a randomized study to see if one is better than another at removing kidney stones quickly and efficiently.

Study Design

• Study Type: Interventional
• Actual Enrollment: 270 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stonebreaker Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Device: Stonebreaker; Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
Active Comparator: Lithoclast Select Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.	Device: Lithoclast Select; Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented
Active Comparator: Cyberwand The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.	Device: Cyberwand; Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.

Outcome Measures

Primary Outcome Measures

1. Stone Clearance Time in mm2/Min [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)

Secondary Outcome Measures

1. Stone-free After First Procedure [Post-operative Day 1]

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

2. Secondary Procedure Required [Within three days of initial procedure]

   Number of participants who required a secondary kidney stone removal procedure

3. Ureteral Stent Placed [Intra-operatively]

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

4. Nephrostomy Tube Placed [Intra-operatively]

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

5. Use of Other Device [Intra-operatively]

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

6. EBL>400mL [Intra-operatively]

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

7. RBC Transfusion [Post-operatively <24 hours]

   Number of participants who required a blood transfusion post-operatively

8. Length of Stay [Post-operatively]

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

9. Post-operative Complications [Post-operative Days 2 and 3]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Scheduled to undergo percutaneous nephrolithotomy for at least one kidney stone measuring 2 cm or greater

• Stone easily visible/measurable on plain abdominal imaging (KUB) or CT scan preoperatively

• Age 18 years or older

• Able to give informed consent

Exclusion Criteria:

• Size of single largest stone less than 2 cm

• Pregnancy

• Active urinary tract infection

• Extracorporeal shockwave lithotripsy within the last three months

• Complex stone anticipating multiple access sites

• Stones that are not clearly able to be measured on KUB or CT scan

• Inability to give informed consent

• Age less than 18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Scottsdale	Phoenix	Arizona	United States	85054
2	Northwestern University	Chicago	Illinois	United States	60611
3	IU Health Physicians Urology	Indianapolis	Indiana	United States	46202
4	Johns Hopkins	Baltimore	Maryland	United States	21224
5	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
6	Duke University	Durham	North Carolina	United States	27710
7	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
8	University of Wisconsin	Madison	Wisconsin	United States	53792
9	University of British Columbia	Vancouver	British Columbia	Canada	V5Z 1M9
10	The University of Western Ontario	London	Ontario	Canada	N6A 4V2

Sponsors and Collaborators

• Indiana Kidney Stone Institute

Investigators

• Principal Investigator: James E Lingeman, MD, IU Health Physicians Urology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• International Kidney Stone Institute - Click here for more information about kidney stone disease

Publications

None provided.

• Responsible Party: James Lingeman, James Lingeman, MD, Indiana Kidney Stone Institute
• ClinicalTrials.gov Identifier: NCT00952315
• Other Study ID Numbers: 09-045
• First Posted: Aug 6, 2009
• Last Update Posted: Jul 5, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by James Lingeman, James Lingeman, MD, Indiana Kidney Stone Institute: kidney stones; intracorporeal lithotriptors; kidney stone removal
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis

Study Results

Participant Flow

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand
Arm/Group Description	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 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	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.
Period Title: Overall Study
STARTED	90	90	90
COMPLETED	64	66	71
NOT COMPLETED	26	24	19

Baseline Characteristics

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand	Total
Arm/Group Description	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 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	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 of all reporting groups
Overall Participants	64	66	71	201
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55.2	58.1	57.4	57
Sex: Female, Male (Count of Participants)
Female	32 50%	34 51.5%	36 50.7%	102 50.7%
Male	32 50%	32 48.5%	35 49.3%	99 49.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
North America	64 100%	66 100%	71 100%	201 100%

Outcome Measures

1. Primary Outcome

Title	Stone Clearance Time in mm2/Min
Description	Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)
Time Frame	collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand
Arm/Group Description	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 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	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.
Measure Participants	64	66	71
Mean (Standard Deviation) [mm^2/min]	24.0 (13.9)	28.9 (16.2)	32.3 (23.4)

2. Secondary Outcome

Title	Stone-free After First Procedure
Description	Number of participants deemed stone-free after initial stone-removal surgery
Time Frame	Post-operative Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand
Arm/Group Description	Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select will be used to breakup and remove 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.
Measure Participants	64	66	71
Count of Participants [Participants]	33 51.6%	43 65.2%	39 54.9%

3. Secondary Outcome

Title	Secondary Procedure Required
Description	Number of participants who required a secondary kidney stone removal procedure
Time Frame	Within three days of initial procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand
Arm/Group Description	Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select will be used to breakup and remove 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.
Measure Participants	64	66	71
Count of Participants [Participants]	15 23.4%	16 24.2%	24 33.8%

4. Secondary Outcome

Title	Ureteral Stent Placed
Description	Participants requiring a ureteral stent to be placed after initial stone removal procedure
Time Frame	Intra-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand
Arm/Group Description	Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select will be used to breakup and remove 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.
Measure Participants	64	66	71
Count of Participants [Participants]	3 4.7%	4 6.1%	5 7%

5. Secondary Outcome

Title	Nephrostomy Tube Placed
Description	Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure
Time Frame	Intra-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand
Arm/Group Description	Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select will be used to breakup and remove 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.
Measure Participants	64	66	71
Count of Participants [Participants]	55 85.9%	59 89.4%	63 88.7%

6. Secondary Outcome

Title	Use of Other Device
Description	Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite
Time Frame	Intra-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand
Arm/Group Description	Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select will be used to breakup and remove 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.
Measure Participants	64	66	71
Count of Participants [Participants]	8 12.5%	9 13.6%	5 7%

7. Secondary Outcome

Title	EBL>400mL
Description	Number of participants with an estimated blood loss greater than 400mL
Time Frame	Intra-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand
Arm/Group Description	Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select will be used to breakup and remove 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.
Measure Participants	64	66	71
Count of Participants [Participants]	4 6.3%	2 3%	3 4.2%

8. Secondary Outcome

Title	RBC Transfusion
Description	Number of participants who required a blood transfusion post-operatively
Time Frame	Post-operatively <24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand
Arm/Group Description	Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select will be used to breakup and remove 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.
Measure Participants	64	66	71
Count of Participants [Participants]	3 4.7%	2 3%	2 2.8%

9. Secondary Outcome

Title	Length of Stay
Description	Number of days participants were in hospital. Operative day is Day 1.
Time Frame	Post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand
Arm/Group Description	Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select will be used to breakup and remove 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.
Measure Participants	64	66	71
Mean (Standard Deviation) [Days]	1.9 (1.5)	2.5 (2.1)	2.6 (2.5)

10. Secondary Outcome

Title	Post-operative Complications
Description	Number of participants who experienced surgery-related post-op complications
Time Frame	Post-operative Days 2 and 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stonebreaker	Lithoclast Select	Cyberwand
Arm/Group Description	Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.	Lithoclast Select will be used to breakup and remove 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.
Measure Participants	64	66	71
Count of Participants [Participants]	10 15.6%	10 15.2%	11 15.5%

Adverse Events

Time Frame	3 months
Arm/Group Title	Stonebreaker		Lithoclast Select		Cyberwand
Arm/Group Description	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 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		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.
All Cause Mortality
	Stonebreaker		Lithoclast Select		Cyberwand
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/66 (0%)		0/71 (0%)
Serious Adverse Events
	Stonebreaker		Lithoclast Select		Cyberwand
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/66 (0%)		0/71 (0%)
Other (Not Including Serious) Adverse Events
	Stonebreaker		Lithoclast Select		Cyberwand
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/64 (28.1%)		19/66 (28.8%)		16/71 (22.5%)
Renal and urinary disorders
Use of another stone breakage device intraoperatively	8/64 (12.5%)		9/66 (13.6%)		5/71 (7%)
Surgical and medical procedures
Post-operative Complications	10/64 (15.6%)		10/66 (15.2%)		11/71 (15.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.