Superpulsed Thulium Fiber Laser VS. Pulse Modulated High Power Holmium:YAG Laser For Retrograde Intrarenal Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 82
- Locations
- 2
- Primary Endpoint
- Number of Participants With Stone Free Status
Study Overview
Brief 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:
- A superpulsed thulium fiber laser (thulium)
- A pulse modulated high power holmium laser (Holmium)
Detailed Description
This is a randomized prospective study. The purpose is to compare the stone free rate and operative efficiency of two leading contemporary laser systems used during retrograde intrarenal surgery for kidney stone disease. The researchers will compare the following two systems:
- A superpulsed thulium fiber laser (thulium)
- A pulse modulated high power holmium laser (Holmium)
The researchers will recruit 82 subjects undergoing single stage unilateral ureteroscopy for renal stones with a volume between >5mm to < 20 mm. Subjects will be randomized to undergo lithotripsy with either Ho:YAG or Thulium lasers.
All subjects will undergo surgical interventions that abide by broadly accepted guidelines and standards of care.
The primary outcome is stone free rate evaluated by postoperative CT scans done 6-12 weeks after surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Stone Free Status
Time Frame: 6-12 weeks postoperative
Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy
Secondary Outcomes
- Fragmentation Speed(Intraoperatively (Day 1))
- Lasing Activity(Intraoperatively (Day 1))
- Energy Utilization(Intraoperatively (Day 1))
Investigators
Mantu Gupta
Professor of Urology
Icahn School of Medicine at Mount Sinai