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NCT Number: NCT06721975

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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-PCNL. However, limited research has directly compared its efficacy and safety and no prospective comparative trials have been published.

This study aims to investigate whether Dornier Thulio p-Tm:YAG laser is non-inferior to TFL in terms of dusting ablation efficiency (J/mm3) and dusting ablation speed (mm3/s) for ureteroscopic stone treatment. To our knowledge no large-scale study has examined the outcomes of p-Tm:YAG compared to TFL for the treatment of kidney stones which warrants an investigation giving the promising results previously reported.

The primary objective is to assess stone dusting ablation efficiency (Joules/stone volume ablated) between both laser systems in vivo for ureteroscopic stone treatment . Secondary objectives include assessing stone dusting ablation speed (stone volume ablated/lasing time) and complication profile of both laser systems.

The investigators hypothesize that dusting ablation efficiency and speed of the p-Tm:YAG laser will be non-inferior to TFL for the treatment of renal stones totaling 7-20 mm in diameter with similar clinical and safety/complication outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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.

Thulium Laser Fiber (TFL)

Device

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

Primary outcomes

  1. The amount of energy used per given stone volume

    Time frame: From enrollment to the follow up imaging at 6-12 weeks

    The primary object is to assess the stone dusting ablation efficiency - efficiency will be defined by amount of laser energy used per stone volume (Joules/mm3)

Secondary outcomes

  1. Laser ablation speed (volume of stone/lasing time = mm3/sec)

    Time frame: From enrollment to the follow up imaging at 6-12 weeks

    Secondary objectives include assessing stone dusting ablation speed. This is assessed by taking the stone volume ablated (mm3) and dividing it by lasing time (seconds) - mm3/sec.

  2. Post-operative complications compared between the two laser systems

    Time frame: From enrollment to the follow up imaging at 6-12 weeks

    Secondary objectives include assessing post-operative complications. This is defined as the proportion of post-operative infections, readmissions to the hospital, and unplanned procedures compared between the two laser systems.

Study contacts

Contact information is provided by the study sponsor or research team.

Jade McDermott, BS

CONTACT

[email protected]

858-777-9721

Roger L Sur, MD

CONTACT

[email protected]

(858) 657-7876

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Dornier MedTech Systems

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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