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| ID | Type | Description | Link |
|---|---|---|---|
| A539800 | Other Identifier | UW Madison | |
| SMPH/UROLOGY | Other Identifier | UW Madison | |
| Protocol Version 10/30/2017 | Other Identifier | UW Madison |
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The primary objective of this study is to compare the time to acceptable stone fragmentation during clinical use of the holmium laser when using energy settings 0.2J vs 0.8J. The hypothesis is that holmium laser energy settings 0.8J will require less time than lower energy settings 0.2J for fragmenting urinary stones. The clinical practice is to treat urinary stones until the stone is reduced to fragments ≤ 2 mm in size. This is determined by using the laser fiber which is 273 microns to visually estimate the size of the resultant fragments as described by Patel et al, J Endo 2014. Investigators will standardize the effect of stone size by creating a ratio of stone size to treatment time. In this study, the frequency is set at 15Hz. Thus, the study contains two arms: 0.2J&15Hz, and 0.8J&15Hz. Patients will be randomized into the two groups by the ratio of 1:1.
The only interventions imposed on subjects as a result of this study are (1) pre-procedural randomization to laser lithotripsy with either 0.2J or 0.8J energy setting, and (2) the use of patient information in describing results. All the other activities are part of the routine clinical practice in the department. Participation in the study will not alter the patients' preoperative, or postoperative care. During surgery, patients' stones will be treated in accordance with the routine clinical practice of fragmenting stones into small pieces (<2 mm). All patients enrolled will undergo routine post-operative follow up including clinic appointments and imaging evaluation. Any complications will be recorded, reported, and treated appropriately. A fixed frequency will be used (15Hz). Thus, the study contains two arms: 0.2J&15Hz, and 0.8J&15Hz. Patients will be randomized into the two groups by the ratio of 1:1. A total of 1 clinic visit (i.e., the stone surgery, approximately 5-6 hours, depending on the duration of the surgery) is needed for this study.
The study procedures are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Holmium:YAG laser: 0.2J&15Hz | Active Comparator | Patients are assigned to treat stones with 0.2J&15Hz of the holmium laser. |
|
| Holmium:YAG laser: 0.8J&15Hz | Experimental | Patients are assigned to treat stones with 0.8J&15Hz of the holmium laser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holmium:YAG laser | Device | Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones) |
| Measure | Description | Time Frame |
|---|---|---|
| Fragmentation Time | The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice) | up to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Operative Time | up to 6 hours | |
| Pre-Operative Stone Size | Pre-operative stone size (on pre-operative CT) will be reported in millimeters. | Retrospective review of health chart at Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Nakada, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Holmium:YAG Laser: 0.2J&15Hz | Patients are assigned to treat stones with 0.2J&15Hz of the holmium laser. Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones) |
| FG001 | Holmium:YAG Laser: 0.8J&15Hz | Patients are assigned to treat stones with 0.8J&15Hz of the holmium laser. Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Holmium:YAG Laser: 0.2J&15Hz | Patients are assigned to treat stones with 0.2J&15Hz of the holmium laser. Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Fragmentation Time | The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice) | Posted | Mean | Standard Deviation | Minutes | up to 6 hours |
|
Within 30 days of the surgery
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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 | Holmium:YAG Laser: 0.2J&15Hz | Patients are assigned to treat stones with 0.2J&15Hz of the holmium laser. Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shuang Li | University of Wisconsin, School of Medicine and Public Health, Department of Urology | 6082638336 | lis@urology.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2017 | Jul 27, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2017 | Jul 15, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Number of Participants With Either Ureteral or Renal Location of Urinary Stone | Urinary stone location will be classified as renal or ureter. | up to 6 hours |
| Number of Participants Treated for Either Single or Multiple Urinary Stones | up to 6 hours |
| Density of Urinary Stones | up to 6 hours |
| Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm | Size of fragments created will be assessed using the laser fiber size as a comparison. | up to 6 hours |
| Withdrawal by Subject |
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| Physician Decision |
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| Lack of equipment |
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| BG001 | Holmium:YAG Laser: 0.8J&15Hz | Patients are assigned to treat stones with 0.8J&15Hz of the holmium laser. Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Total Operative Time | Posted | Mean | Standard Deviation | Minutes | up to 6 hours |
|
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| Secondary | Pre-Operative Stone Size | Pre-operative stone size (on pre-operative CT) will be reported in millimeters. | Posted | Mean | Standard Deviation | mm | Retrospective review of health chart at Baseline |
|
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|
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| Secondary | Number of Participants With Either Ureteral or Renal Location of Urinary Stone | Urinary stone location will be classified as renal or ureter. | Posted | Number | Participants | up to 6 hours |
|
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| Secondary | Number of Participants Treated for Either Single or Multiple Urinary Stones | Posted | Number | Participants | up to 6 hours |
|
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| Secondary | Density of Urinary Stones | Posted | Mean | Standard Deviation | Hounsfield units | up to 6 hours |
|
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|
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| Secondary | Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm | Size of fragments created will be assessed using the laser fiber size as a comparison. | Posted | Number | Participants | up to 6 hours |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Holmium:YAG Laser: 0.8J&15Hz | Patients are assigned to treat stones with 0.8J&15Hz of the holmium laser. Holmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones) | 0 | 15 | 0 | 15 | 0 | 15 |
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| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D007674 | Kidney Diseases |
| 3mm |
|