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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thulium Fibre Laser (TFL) | Experimental | Patients randomized to this arm will undergo treatment using the TFL. |
|
| MOSES Holmium Laser | Experimental | Patients randomized to this arm will undergo treatment using the MOSES Holmium laser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thulium Fibre Laser | Device | Participants will undergo treatment using the TFL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Time | Measured in number of minutes from the insertion of the ureteroscope to the removal of the ureteroscope. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 and 12 weeks post-op |
| Total operative time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shalyn Littlefield, MSc | Contact | (807) 684-6000 | shalyn.littlefield@tbh.net | |
| Hazem Elmansy, MD | Contact | (807) 684-6000 | elmansyh@tbh.net |
| Name | Affiliation | Role |
|---|---|---|
| Hazem Elmansy, MD | Urologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thunder Bay Regional Health Sciences Centre | Recruiting | Thunder Bay | Ontario | P7B 6V4 | Canada |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| MOSES Holmium Laser | Device | Participants will undergo treatment using the MOSES Holmium laser. |
|
Measured in n minutes from the anesthesia induction until placement of the stent. |
| Intraoperative |
| Lasing time | Measured in minutes and defined as the time the laser was in use, not including pedal pauses. | Intraoperative |
| Total energy used | Measured in kilojoules, defined as energy used to fragment the stones into small pieces (≤2 mm). | 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. | Intraoperative |
| Number of times the laser pedals are pressed | Measured as a numerical value, defined as number of left, right, and total pedal presses | Intraoperative |
| Percentage of Patients with Post-op Complications | Percentage of patients that results with a post-op complication | 4 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |