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Recruiting NCT05598645

Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser for Ureteroscopic Management of Kidney Stones

No phase Interventional Kidney Stone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thulium Fibre Laser, MOSES Holmium Laser.
Who it may be relevant to
Registry conditions: Kidney Stone. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser in Ureteroscopic Management of Kidney Stones 10-20mm: A Randomized Prospective Clinical Trial

Overview

This study aims to compare the efficacy and safety of both types of lasers, Holmium MOSES and TFL, in management of kidney stones requiring treatment.

Detailed description

The prevalence of kidney stones has been increasing over the last two decades with lifetime recurrence risk reported to be as high as 50%. Holmium lasers are nowadays considered the "gold standard" for treatment of urinary tract stones.

Recently, the holmium laser urology platform from Lumenis has been updated to include a new technology called MOSES, which provides improved energy delivery of the laser to treat the stones, reduces migration of the stone during the procedure, and limits potential collateral tissue damage.

A new generation of lasers has evolved due to the advances in laser fiber technology, leading to the development of the Thulium Fiber Laser (TFL). TFL can operate within a large range of energy, frequency and pulse duration settings. The small fiber size is one of the main advantages of TFL, as it allows better endoscope performance through easier deflection and bigger working channel space. Furthermore, it produces small stone fragments and better dusting capabilities compared to the standard Holmium laser when adjusted on the same power settings.

This study will compare the efficacy and safety of Holmium MOSES and TFL in management of kidney stones requiring treatment.

Interventions

  • Device Thulium Fibre Laser
    Participants will undergo treatment using the TFL
  • Device MOSES Holmium Laser
    Participants will undergo treatment using the MOSES Holmium laser.

Primary outcome measures

  • Procedural Time [Time frame: Intraoperative]
Secondary outcome measures (7)
  • Stone Free Rate (SFR) [Time frame: 4 and 12 weeks post-op]
  • Total operative time [Time frame: Intraoperative]
  • Lasing time [Time frame: Intraoperative]
  • Total energy used [Time frame: Intraoperative]
  • Laser efficiency [Time frame: Intraoperative]
  • Number of times the laser pedals are pressed [Time frame: Intraoperative]
  • Percentage of Patients with Post-op Complications [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

  • 18 years of age and over at the time of enrollment.
  • Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx.
  • Written informed consent to participate in the study
  • Ability to comply with the requirements of the study procedures

Exclusion criteria

  • Patients with ipsilateral distal ureteral stones or stricture.
  • Stone size > 20 mm or multiple kidney stones in different calyces.
  • Previous shock wave lithotripsy (SWL) treatment for the same stone.
  • Participants with active urinary tract infection until appropriately treated
  • Uncorrected coagulopathy (anticoagulants or blood thinners which cannot be withheld before surgery).
  • Pregnancy.
  • Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
  • Participants who are uncooperative or cannot follow instructions.
  • Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent.
  • Patients with solitary kidney.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Thunder Bay Regional Health Sciences Centre — Thunder Bay

Identifiers

NCT: NCT05598645 · RP-791

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗