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Percutaneous nephrolithotomy (PNL), in conjunction with intracorporeal lithotripsy, allows for the rapid removal of any kidney stone regardless of size. Currently, the choice of intracorporeal lithotripters includes ultrasonic, pneumatic, and combined ultrasonic/pneumatic energy sources. Recently, a novel dual probe design as been introduced by Cybersonics of Erie, Pennsylvania. This dual probe intracorporeal lithotrite is called the Cyberwand, and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 Hz. As this new design has the potential to revolutionize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.
Percutaneous nephrolithotomy (PNL) is used to remove large and complex stones from the upper urinary tract. Intracorporeal lithotripsy is an integral part of PNL. Commercially available intracorporeal lithotripsy modalities include ultrasonic, pneumatic, and combined ultrasonic and pneumatic models. Each modality has its inherent advantages and disadvantages. Ultrasonic lithotrites are capable of fragmenting stones while concomitantly suctioning out fragments. Unfortunately some stones are hard enough to resist fragmentation from ultrasonic lithotripsy. Pneumatic lithotrites are able to fragment all stones regardless of hardness, but this modality is unable to suction out stone pieces at the same time fragmentation is occurring. The newest lithotrite which combines both ultrasonic and pneumatic components is capable of fragmenting any stone, but also has some inherent limitations. The handpiece of the lithotripsy device is somewhat cumbersome, the suction component can clog, and the device has overheated at the maximal settings (Kuo et al). Current intracorporeal lithotrites, while functional, can certainly be improved.
Recently, a novel dual probe design has been introduced by Cybersonics of Erie, PA. This dual probe intracorporeal lithotrite is called the Cyberwand and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 Hz. As this new design has the potential to revolutionalize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Cyberwand |
|
| B | Active Comparator | Currently available lithotripsy technology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyberwand | Device | FDA approved - dual probe intracorporeal lithotrite |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney Stone Clearance Rate | stone clearance rate calculated in mm^2/min per protocol specification | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James E. Lingeman, MD | Methodist Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Dept. of Urology | Chicago | Illinois | 60611 | United States | ||
| Methodist Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15072622 | Background | Kuo RL, Paterson RF, Siqueira TM Jr, Evan AP, McAteer JA, Williams JC Jr, Lingeman JE. In vitro assessment of lithoclast ultra intracorporeal lithotripter. J Endourol. 2004 Mar;18(2):153-6. doi: 10.1089/089277904322959789. |
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Patients undergoing percutaneous nephrolithotomy with a target stone size greater than 2cm
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyberwand | Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite |
| FG001 | Currently Available Lithotripsy Technology | Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyberwand | Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite |
| BG001 | Currently Available Lithotripsy Techology | Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Kidney Stone Clearance Rate | stone clearance rate calculated in mm^2/min per protocol specification | Sample size calculations were performed using a two-sided Student's t-test with a power of 90% and a significance level of α = 0.05 | Posted | Mean | Full Range | mm^2/min | 6 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 | Cyberwand | Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fever | Infections and infestations | Systematic Assessment |
Multiple surgeons were involved,thus subtle differences in PCNL technique existed between sites. Some surgeons may have defined the stone removal time differently.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Lingeman, MD | IU Health Methodist Hospital | 317-962-0870 | lrawlings@iuhealth.org |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| single probe ultrasonic |
| Device |
FDA-approved - single probe ultrasonic |
|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| John's Hopkins University | Baltimore | Maryland | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Vancouver Hospital | Vancouver | British Columbia | Canada |
| University of Western Ontario - St. Joseph's Hospital | London | Ontario | Canada |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 34 |
| 10 |
| 34 |
| EG001 | Currently Available Lithotripsy Technology | Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic | 0 | 36 | 15 | 36 |
| hydronephrosis | Renal and urinary disorders | Systematic Assessment |
|
| ileus | Gastrointestinal disorders | Systematic Assessment |
|
| perinephric haematoma | Renal and urinary disorders | Systematic Assessment |
|
| persistent flank pain | General disorders | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| respiratory difficulty | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| discharged home with nephrostomy tube | Renal and urinary disorders | Systematic Assessment |
|
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| 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 |