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NCT Number: NCT05598645

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location status: Recruiting

Location contact

Shalyn Littlefield, MSc

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Thulium Fibre Laser

Device

Participants will undergo treatment using the TFL

MOSES holmium laser

Device

Participants will undergo treatment using the MOSES Holmium laser.

Primary outcomes

  1. Procedural Time

    Time frame: Intraoperative

    Measured in number of minutes from the insertion of the ureteroscope to the removal of the ureteroscope.

Secondary outcomes

  1. Stone Free Rate (SFR)

    Time frame: 4 and 12 weeks post-op

    SRF will be defined as the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the urinary tract which were defined as ˂4 mm, asymptomatic, non-obstructive and non-infectious stone particles.

  2. Total operative time

    Time frame: Intraoperative

    Measured in n minutes from the anesthesia induction until placement of the stent.

  3. Lasing time

    Time frame: Intraoperative

    Measured in minutes and defined as the time the laser was in use, not including pedal pauses.

  4. Total energy used

    Time frame: Intraoperative

    Measured in kilojoules, defined as energy used to fragment the stones into small pieces (≤2 mm).

  5. Laser efficiency

    Time frame: Intraoperative

    Measured as mm per minute and defined as the stone size (mm) that can be treated every minute; the cumulative stone size (adding the maximum size of each stone that is treated during the surgery) is divided by the lasering time.

  6. Number of times the laser pedals are pressed

    Time frame: Intraoperative

    Measured as a numerical value, defined as number of left, right, and total pedal presses

  7. Percentage of Patients with Post-op Complications

    Time frame: 4 weeks

    Percentage of patients that results with a post-op complication

Study contacts

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

Hazem Elmansy, MD

CONTACT

[email protected]

(807) 684-6000

Shalyn Littlefield, MSc

CONTACT

[email protected]

(807) 684-6000

Sponsors and collaborators

Lead sponsor

Thunder Bay Regional Health Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 28, 2022
Registry last updated
Aug 7, 2024

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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