Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With… (NCT06070714) | Clinical Trial Compass
CompletedNot Applicable
Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones
United States178 participantsStarted 2023-09-07
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.