Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones
NCT ID: NCT06070714
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
177 participants
INTERVENTIONAL
2023-09-07
2025-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Patients' stone size in a single renal unit of greater than or equal to 5 millimeters (mm) and less than or equal to 20 mm. Stone size is defined as the largest diameter of a single stone on pre-operative CT as assessed by the urologist. Patients with multiple stones will be included as long as their largest stone size falls within the above parameters.
Exclusion Criteria
* Patients with transplant kidneys or other anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture
* Patients with irreversible coagulopathy
* Patients with known ureteral stricture disease
* Patient who do not have a pre-operative CT
* Non-English speaking patients and patients in other vulnerable groups such as lacking of decision-making capability, prisoner, or adult unable to consent
* Uric acid composition greater than 50 percent on pre operative stone analysis. Patients will be excluded post operatively if stone analysis from the time of surgery is greater than 50 percent uric acid.
* Prior ureteroscopy within 6 weeks of current surgery
* Urothelial tumor(s), direct extraction of the stone(s) without needing laser lithotripsy, and failure to reach the stone in the upper urinary tract with the ureteroscope
* Patients with only ureteral stones (ureteropelvic junction stones may be included as long as treated in the kidney)
* Patients with renal tubular acidosis or medullary sponge kidney
18 Years
89 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Stephen Nakada, MD, FACS, FRCS
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of California - Los Angeles
Los Angeles, California, United States
Mount Sinai Health System
New York, New York, United States
Glickman Urological & Kidney Institute
Cleveland, Ohio, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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Other Identifiers
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Urology
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 5/21/24
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0932
Identifier Type: -
Identifier Source: org_study_id
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