HealthTree
[logo] HealthTree Foundation
search more_vert
close
person Sign In / Create Account
arrow_back

Go back to trials list

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


Description

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

Trial Eligibility

Inclusion Criteria: * 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 Exclusion Criteria: * Concomitant stones in the ureter * Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture * Prior radiotherapy to the abdomen or pelvis * Neurogenic bladder or spinal cord injury * Pregnancy * Untreated UTI

Study Info

Organization

University of California, San Diego


Primary Outcome

The amount of energy used per given stone volume


Outcome Timeframe From enrollment to the follow up imaging at 6-12 weeks

NCTID NCT06721975

Phases NA

Primary Purpose TREATMENT

Start Date 2024-08-01

Completion Date 2026-08-01

Enrollment Target 50

Interventions

DEVICE Thulio pulsed Thulium:YAG (p-Tm:YAG)

DEVICE Thulium Laser Fiber (TFL)

Locations Recruiting

University of California, San Diego

United States, California, San Diego


Interested in joining this trial?

Our dedicated patient navigators are here to support you by reviewing the eligibility criteria to see if you might qualify for this trial.

newsletter icon

Your Source for Expert Insights & Support in Kidney Disease.

By subscribing to the Healthtree newsletter, you'll receive the latest research, treatment updates, and expert insights to help you navigate your health.