RecruitingNot ApplicableNCT06721975

Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)

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


Sponsor

University of California, San Diego

Enrollment

50 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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

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Interventions

DEVICEThulio pulsed Thulium:YAG (p-Tm:YAG)

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.

DEVICEThulium Laser Fiber (TFL)

The thulium fiber laser (TFL) has demonstrated effectiveness in this procedure


Locations(1)

University of California, San Diego

San Diego, California, United States

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NCT06721975


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