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| ID | Type | Description | Link |
|---|---|---|---|
| Urology | Other Identifier | UW Madison | |
| Protocol Version 5/21/24 | Other Identifier | UW Madison |
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This is a prospective randomized controlled trial designed to assess the efficacy and safety of Lumenis® Pulse™ P120H holmium laser system with the Moses technology (holmium laser with pulse modulation) versus the Soltive™ SuperPulsed Laser System with the thulium fiber laser (thulium fiber laser), in dusting of renal stones during ureteroscopy with laser lithotripsy. 310 participants will be enrolled across 5 research sites.
This study will be a randomized clinical trial comparing ureteroscopy with laser lithotripsy with the Lumenis® Pulse™ P120H holmium laser system with the Moses technology (holmium laser with pulse modulation) versus the Soltive™ SuperPulsed Laser System with the thulium fiber laser technology (thulium fiber laser).
The primary objective is to compare the stone free rate as determined by computed tomography (CT) scan at two months (6-10 weeks) post operatively. A single urologist will evaluate all CT scans for residual stones and will be blinded to which laser was used during ureteroscopy.
The following information will be collected for research purposes as secondary outcomes: (1) stone treatment time (time from the start of lasing to the end of lasing; minutes); (2) total operative time (minutes); (3) lasing time (minutes, time the laser was in use, not including pedal pauses); (4) total energy used (kilojoules, kJ); (5) laser efficiency (mm per minute); (6) number of times the laser pedals are pressed (left, right, and total pedal presses); (7) laser fiber size; (8) stone analysis; (9) complications, and (10) patients' quality of life.
The results from the pre- and post-operative quality of life survey (WISQOL short form) will be obtained from the patient's medical record. A total of 3 clinic visits (i.e., the pre-operative visit and the stone surgery, one post-operative visit after 2 months of the surgery) will be needed for this study.
All visits are standard of care. Stone parameters (i.e. size, location, Hounsfield units, presence of hydronephrosis, stone volume, and composition), demographic information, co-morbidities, and post-operative parameters will be collected from the medical record in HealthLink.
The Thulium laser company is not involved in this research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Holmium laser with pulse modulation | Active Comparator |
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| Thulium fiber laser | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holmium laser with pulse modulation | Device | The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed. |
| Measure | Description | Time Frame |
|---|---|---|
| Stone Free Rate | The primary objective of this study is to compare the stone free rate as determined by ultra-low dose limited renal CT at 2 months post operatively between the holmium laser with pulse modulation and the thulium fiber laser. | Post-operative (up to 10 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Stone Treatment Time in Minutes | Time from the start of lasing to the end of lasing. | day of procedure (up to 3 hours) |
| Procedural Time | Time from the insert to removal of the instrument. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Nakada, MD, FACS, FRCS | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - Los Angeles | Los Angeles | California | 90095 | United States | ||
| Mount Sinai Health System |
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| ID | Title | Description |
|---|---|---|
| FG000 | Holmium Laser With Pulse Modulation | Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | May 13, 2025 |
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Participants will be randomized (ratio 1:1) to be treated with either the holmium laser with pulse modulation or the thulium fiber laser. Each site will randomize their own participants. Block randomization in block sizes of 4 will be used to assign participants to each laser treatment group. If unable to use the specified laser for any reason, the participant will be considered a withdrawal
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A single urologist will evaluate all CT scans for residual stones and will be blinded to which laser was used during ureteroscopy.
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| Thulium fiber laser | Device | The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns. |
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| day of procedure (up to 3 hours) |
| Total Energy Used in Kilojoules | The total energy used for the stone surgery is documented by the laser machine. With reported case averages ranging from 0.1 to 42.1 kJ depending on stone size and technique (e.g., dusting vs. fragmentation).This parameter is a measure of the efficiency of stone treatment. | day of procedure (up to 3 hours) |
| Number of Participants With Complications | All complications are documented during the procedure and the total follow-up time (up to 10 weeks). This outcome measure include the procedural complications and post-operative complications. | day of procedure (up to 10 weeks) |
| Participant Quality of Life as Measured by the WISQOL Short Form Score Pre-procedure Assessment | WISQOL short form is a 6 item questionnaire which can be scored from 1(worst outcome) to 5 (best outcome). The raw score range is 6-30. In the study, standardized total score is used. The range of the standardized total score is 0-100 with higher scores meaning better outcomes. | before the procedure (up to 3 hours before procedures) |
| Participant Quality of Life as Measured by the WISQOL Short Form Score Post-procedure Assessment | WISQOL short form is a 6 item questionnaire which can be scored from 1 (worst outcome) to 5 (best outcome). The raw score range is 6-30. In the study, standardized total score is used. The range of the standardized total score is 0-100 with higher scores meaning better outcomes. | Post-operative (up to 10 weeks) |
| New York |
| New York |
| 10029 |
| United States |
| Glickman Urological & Kidney Institute | Cleveland | Ohio | 44125 | United States |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 57392 | United States |
| Thulium Fiber Laser |
Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Holmium Laser With Pulse Modulation | Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed. |
| BG001 | Thulium Fiber Laser | Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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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| 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 Free Rate | The primary objective of this study is to compare the stone free rate as determined by ultra-low dose limited renal CT at 2 months post operatively between the holmium laser with pulse modulation and the thulium fiber laser. | Posted | Count of Participants | Participants | Post-operative (up to 10 weeks) |
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| Secondary | Stone Treatment Time in Minutes | Time from the start of lasing to the end of lasing. | Posted | Mean | Standard Deviation | minutes | day of procedure (up to 3 hours) |
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| Secondary | Procedural Time | Time from the insert to removal of the instrument. | Posted | Mean | Standard Deviation | minutes | day of procedure (up to 3 hours) |
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| Secondary | Total Energy Used in Kilojoules | The total energy used for the stone surgery is documented by the laser machine. With reported case averages ranging from 0.1 to 42.1 kJ depending on stone size and technique (e.g., dusting vs. fragmentation).This parameter is a measure of the efficiency of stone treatment. | Posted | Mean | Standard Deviation | kilojoules | day of procedure (up to 3 hours) |
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| Secondary | Number of Participants With Complications | All complications are documented during the procedure and the total follow-up time (up to 10 weeks). This outcome measure include the procedural complications and post-operative complications. | Posted | Count of Participants | Participants | day of procedure (up to 10 weeks) |
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| Secondary | Participant Quality of Life as Measured by the WISQOL Short Form Score Pre-procedure Assessment | WISQOL short form is a 6 item questionnaire which can be scored from 1(worst outcome) to 5 (best outcome). The raw score range is 6-30. In the study, standardized total score is used. The range of the standardized total score is 0-100 with higher scores meaning better outcomes. | Posted | Mean | Standard Deviation | score on a scale | before the procedure (up to 3 hours before procedures) |
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| Secondary | Participant Quality of Life as Measured by the WISQOL Short Form Score Post-procedure Assessment | WISQOL short form is a 6 item questionnaire which can be scored from 1 (worst outcome) to 5 (best outcome). The raw score range is 6-30. In the study, standardized total score is used. The range of the standardized total score is 0-100 with higher scores meaning better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Post-operative (up to 10 weeks) |
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From stone surgery to 10 week post operative follow up
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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 Laser With Pulse Modulation | Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed. | 0 | 89 | 0 | 89 | 0 | 89 |
| EG001 | Thulium Fiber Laser | Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns. | 0 | 89 | 0 | 89 | 0 | 89 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Nakada | University of Wisconsin | 608.263.1359 | nakada@urology.wisc.edu |
| Dec 9, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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