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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stonebreaker | Active Comparator | Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. |
|
| Lithoclast Select | Active Comparator | Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. |
|
| Cyberwand | Active Comparator | The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyberwand | Device | Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented. |
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| Measure | Description | Time Frame |
|---|---|---|
| Stone Clearance Time in mm2/Min | Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min) | collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free After First Procedure | Number of participants deemed stone-free after initial stone-removal surgery | Post-operative Day 1 |
| Secondary Procedure Required | Number of participants who required a secondary kidney stone removal procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James E Lingeman, MD | IU Health Physicians Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Phoenix | Arizona | 85054 | United States | ||
| Northwestern University |
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| Label | URL |
|---|---|
| International Kidney Stone Institute - Click here for more information about kidney stone disease | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Lithoclast Select |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Stonebreaker | Device | Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. |
|
| Lithoclast Select | Device | Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented |
|
| Within three days of initial procedure |
| Ureteral Stent Placed | Participants requiring a ureteral stent to be placed after initial stone removal procedure | Intra-operatively |
| Nephrostomy Tube Placed | Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure | Intra-operatively |
| Use of Other Device | Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite | Intra-operatively |
| EBL>400mL | Number of participants with an estimated blood loss greater than 400mL | Intra-operatively |
| RBC Transfusion | Number of participants who required a blood transfusion post-operatively | Post-operatively <24 hours |
| Length of Stay | Number of days participants were in hospital. Operative day is Day 1. | Post-operatively |
| Post-operative Complications | Number of participants who experienced surgery-related post-op complications | Post-operative Days 2 and 3 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| IU Health Physicians Urology | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins | Baltimore | Maryland | 21224 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| University of British Columbia | Vancouver | British Columbia | V5Z 1M9 | Canada |
| The University of Western Ontario | London | Ontario | N6A 4V2 | Canada |
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 |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stone Clearance Time in mm2/Min | Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min) | Posted | Mean | Standard Deviation | mm^2/min | collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | Stone-free After First Procedure | Number of participants deemed stone-free after initial stone-removal surgery | Posted | Count of Participants | Participants | Post-operative Day 1 |
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| Secondary | Secondary Procedure Required | Number of participants who required a secondary kidney stone removal procedure | Posted | Count of Participants | Participants | Within three days of initial procedure |
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| Secondary | Ureteral Stent Placed | Participants requiring a ureteral stent to be placed after initial stone removal procedure | Posted | Count of Participants | Participants | Intra-operatively |
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| Secondary | Nephrostomy Tube Placed | Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure | Posted | Count of Participants | Participants | Intra-operatively |
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| ||||||||||||||||||||||||||||||||||
| Secondary | Use of Other Device | Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite | Posted | Count of Participants | Participants | Intra-operatively |
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| Secondary | EBL>400mL | Number of participants with an estimated blood loss greater than 400mL | Posted | Count of Participants | Participants | Intra-operatively |
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| Secondary | RBC Transfusion | Number of participants who required a blood transfusion post-operatively | Posted | Count of Participants | Participants | Post-operatively <24 hours |
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| Secondary | Length of Stay | Number of days participants were in hospital. Operative day is Day 1. | Posted | Mean | Standard Deviation | Days | Post-operatively |
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| |||||||||||||||||||||||||||||||||
| Secondary | Post-operative Complications | Number of participants who experienced surgery-related post-op complications | Posted | Count of Participants | Participants | Post-operative Days 2 and 3 |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 64 | 0 | 64 | 18 | 64 |
| EG001 | 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 | 0 | 66 | 0 | 66 | 19 | 66 |
| EG002 | 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. | 0 | 71 | 0 | 71 | 16 | 71 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Use of another stone breakage device intraoperatively | Renal and urinary disorders | Systematic Assessment |
| ||
| Post-operative Complications | Surgical and medical procedures | Systematic Assessment | Number of participants who experienced post-operative complications |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Lingeman, MD | IU Health Physicians Urology | 317-962-3700 |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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