An interventional study of Thulio pulsed Thulium:YAG (p-Tm:YAG) and Thulium Laser Fiber (TFL) in Kidney Stones and Nephrolithiasis, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
This research study is being conducted to assess the ability and efficiency of two laser systems to break up kidney stones during ureteroscopy with laser lithotripsy for kidney stone treatment.
Ureteroscopic stone treatment is a minimally invasive procedure commonly performed for kidney stones. Recently, the thulium fiber laser (TFL) has demonstrated effectiveness in this procedure. A new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG ) is beginning to be studied in vitro and in vivo. Dornier Thulio p-Tm:YAG may represent an attractive new laser platform, with comparable properties to TFL including decreased retropulsion, smaller dust, and improved ablation efficiency relative to Ho:YAG. Moreover, the p-Tm:YAG laser has been shown to be effective in treating a wide range of human stone types. The Dornier Thulio p-Tm:YAG laser has been tested clinically in a limited fashion via pilot studies in URS and the RevoLix Hybrid Thulium Laset (HTL) was studied in mini-PCNL. However, limited research has directly compared its efficacy and safety and no prospective comparative trials have been published.
This study aims to investigate whether Dornier Thulio p-Tm:YAG laser is non-inferior to TFL in terms of dusting ablation efficiency (J/mm3) and dusting ablation speed (mm3/s) for ureteroscopic stone treatment. To our knowledge no large-scale study has examined the outcomes of p-Tm:YAG compared to TFL for the treatment of kidney stones which warrants an investigation giving the promising results previously reported.
The primary objective is to assess stone dusting ablation efficiency (Joules/stone volume ablated) between both laser systems in vivo for ureteroscopic stone treatment . Secondary objectives include assessing stone dusting ablation speed (stone volume ablated/lasing time) and complication profile of both laser systems.
The investigators hypothesize that dusting ablation efficiency and speed of the p-Tm:YAG laser will be non-inferior to TFL for the treatment of renal stones totaling 7-20 mm in diameter with similar clinical and safety/complication outcomes.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 50 is below the median of 86 across 391 interventional studies indexed under Kidney Calculi.
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This is a new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG)
Device: Thulio pulsed Thulium:YAG (p-Tm:YAG)
The thulium fiber laser (TFL) has demonstrated effectiveness in this procedure.
Device: Thulium Laser Fiber (TFL)
A new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG ) is beginning to be studied in vitro and in vivo. Dornier Thulio p-Tm:YAG may represent an attractive new laser platform, with comparable properties to TFL including decreased retropulsion, smaller dust, and improved ablation efficiency relative to Ho:YAG.
The thulium fiber laser (TFL) has demonstrated effectiveness in this procedure
The amount of energy used per given stone volume
The primary object is to assess the stone dusting ablation efficiency - efficiency will be defined by amount of laser energy used per stone volume (Joules/mm3)
Time frame: From enrollment to the follow up imaging at 6-12 weeks
Laser ablation speed (volume of stone/lasing time = mm3/sec)
Secondary objectives include assessing stone dusting ablation speed. This is assessed by taking the stone volume ablated (mm3) and dividing it by lasing time (seconds) - mm3/sec.
Time frame: From enrollment to the follow up imaging at 6-12 weeks
Post-operative complications compared between the two laser systems
Secondary objectives include assessing post-operative complications. This is defined as the proportion of post-operative infections, readmissions to the hospital, and unplanned procedures compared between the two laser systems.
Time frame: From enrollment to the follow up imaging at 6-12 weeks
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