N/A
N=82
Thulium vs. Hol:YAG Laser
Nephrolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT05808257 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Stone Free Status — 27; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Thulium Fibre Laser (Device); Holmium:Yttrium-Aluminum-Garnet (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Stone Free Status |
27; 26 | — |
| SECONDARY Fragmentation Speed |
0.25; 0.29 | — |
| SECONDARY Lasing Activity |
58.0; 46.1 | — |
| SECONDARY Energy Utilization |
13.6; 17.7 | — |
Summary
This is a randomized prospective study to compare stone free rates and operative efficiency of two laser systems used during retrograde intrarenal surgery for kidney stone disease:
1. A superpulsed thulium fiber laser (thulium)
2. A pulse modulated high power holmium laser (Holmium)
Eligibility Criteria
Inclusion criteria
- Undergoing single stage unilateral RIRS for total stone burden volume >5mm to 50% on stone analysis
- Prior ureteroscopy within 6 weeks of current surgery
- Irreversible coagulopathy
- 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.
Data sourced from ClinicalTrials.gov (NCT05808257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.