Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4, Canada
Location status: Recruiting
NCT Number: NCT05598645
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Thunder Bay, Ontario, P7B 6V4, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will undergo treatment using the TFL
Participants will undergo treatment using the MOSES Holmium laser.
Time frame: Intraoperative
Measured in number of minutes from the insertion of the ureteroscope to the removal of the ureteroscope.
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.
Time frame: Intraoperative
Measured in n minutes from the anesthesia induction until placement of the stent.
Time frame: Intraoperative
Measured in minutes and defined as the time the laser was in use, not including pedal pauses.
Time frame: Intraoperative
Measured in kilojoules, defined as energy used to fragment the stones into small pieces (≤2 mm).
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.
Time frame: Intraoperative
Measured as a numerical value, defined as number of left, right, and total pedal presses
Time frame: 4 weeks
Percentage of patients that results with a post-op complication
Contact information is provided by the study sponsor or research team.
Hazem Elmansy, MD
CONTACT
Shalyn Littlefield, MSc
CONTACT
Thunder Bay Regional Health Research Institute
Other
Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser in Ureteroscopic Management of Kidney Stones 10-20mm: A Randomized Prospective Clinical Trial
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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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