Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones

Renal Stone Clinical Trial

Official title:

Multi-Center Randomized Clinical Trial Evaluating the Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06070714
• Other study ID #: 2023-0932
• Secondary ID: UrologyProtocol
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 310
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Patients with renal stones who require endoscopic laser treatment in the outpatient operating room. Patients may have an ureteropelvic junction (UPJ) stone if the treatment of the stone is completed in the kidney.
• 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:

• Pregnant patients
• 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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Renal Stone

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Glickman Urological & Kidney Institute	Cleveland	Ohio
United States	Wexner Medical Center	Columbus	Ohio
United States	University of California	Los Angeles	California
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	Mount Sinai Health System	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 months post-op (up to 10 weeks on study)
Secondary	Stone Treatment Time in Minutes	Time from the start of lasing to the end of lasing.	day of procedure (up to 3 hours)
Secondary	Total Operative Time in Minutes		day of procedure (up to 3 hours)
Secondary	Procedural time	time from the insert to removal of the instrument	day of procedure (up to 3 hours)
Secondary	Total Energy Used in kilojoules		day of procedure (up to 3 hours)
Secondary	Laser Efficiency in millimeters per minute		day of procedure (up to 3 hours)
Secondary	Number of Participants with Procedural Complications		day of procedure (up to 3 hours)
Secondary	Participant Quality of Life as Measured by the WISQOL Short Form Score	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 5-30. In the study, standardized total score is used. the range of the standardized total score is 0-100.	pre-operative (baseline) and post-operative (up to 10 weeks)