An interventional study of Thulium Fibre Laser and MOSES Holmium Laser in Kidney Stone, sponsored by Thunder Bay Regional Health Research Institute. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Thunder Bay Regional Health Research Institute · Not applicable, Interventional, and Treatment
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.
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.
605 studies on the registry are indexed under Kidney Calculi; 164 are open to participants now.
This study's planned enrollment of 174 is above the median of 90 across 464 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Thunder Bay Regional Health Research Institute is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Patients randomized to this arm will undergo treatment using the TFL.
Device: Thulium Fibre Laser
Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.
Device: MOSES Holmium Laser
Participants will undergo treatment using the TFL
Participants will undergo treatment using the MOSES Holmium laser.
Procedural Time
Measured in number of minutes from the insertion of the ureteroscope to the removal of the ureteroscope.
Time frame: Intraoperative
Stone Free Rate (SFR)
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.
Time frame: 4 and 12 weeks post-op
Total operative time
Measured in n minutes from the anesthesia induction until placement of the stent.
Time frame: Intraoperative
Lasing time
Measured in minutes and defined as the time the laser was in use, not including pedal pauses.
Time frame: Intraoperative
Total energy used
Measured in kilojoules, defined as energy used to fragment the stones into small pieces (≤2 mm).
Time frame: Intraoperative
Laser efficiency
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.
Time frame: Intraoperative
Number of times the laser pedals are pressed
Measured as a numerical value, defined as number of left, right, and total pedal presses
Time frame: Intraoperative
Percentage of Patients with Post-op Complications
Percentage of patients that results with a post-op complication
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Jun 2026, 46 months after the start.
Of 231 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 46 months is above that.
Counting every sponsor, half of 248 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Thunder Bay Regional Health Research Institute