Prospective Single-center Study Comparing Thulium Fiber Laser to Pulsed Thulium:YAG Laser in the Ureteroscopic Treatment of Nephrolithiasis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Solitary renal stone 7 to 20 mm in size or in the case of multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) of 7-20 mm is required

• Must be a suitable operative candidate for flexible ureteroscopy per American Urological Association guidelines

• Must be able to give consent

• Bilateral ureteroscopy will be permitted but only the first side (per surgeon discretion) will be included in the study

• Surgeons participating in the study must be urological attending surgeons or fellows with subspecialty training in Endourology

Locations
United States
California
University of California, San Diego
RECRUITING
San Diego
Contact Information
Primary
Jade McDermott, BS
j3mcdermott@health.ucsd.edu
858-777-9721
Backup
Roger L Sur, MD
rlsur@health.ucsd.edu
(858) 657-7876
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Experimental: p-Tm:YAG laser system
This is a new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG)
Active_comparator: TFL laser system
The thulium fiber laser (TFL) has demonstrated effectiveness in this procedure.
Sponsors
Collaborators: Dornier MedTech Systems
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov