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

Kidney Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598645
• Other study ID #: RP-791
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2022
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Thunder Bay Regional Health Research Institute
• Contact: Shalyn Littlefield, MSc
• Phone: (807) 684-6000
• Email: shalyn.littlefield[@]tbh.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age and over at the time of enrollment.

2. Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx.

3. Written informed consent to participate in the study

4. Ability to comply with the requirements of the study procedures

Exclusion Criteria:

1. Patients with ipsilateral distal ureteral stones or stricture.

2. Stone size > 20 mm or multiple kidney stones in different calyces.

3. Previous shock wave lithotripsy (SWL) treatment for the same stone.

4. Participants with active urinary tract infection until appropriately treated

5. Uncorrected coagulopathy (anticoagulants or blood thinners which cannot be withheld before surgery).

6. Pregnancy.

7. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.

8. Participants who are uncooperative or cannot follow instructions.

9. Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent.

10. Patients with solitary kidney.

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

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

Locations

Country	Name	City	State
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Thunder Bay Regional Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Time	Measured in number of minutes from the insertion of the ureteroscope to the removal of the ureteroscope.	Intraoperative
Secondary	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
Secondary	Total operative time	Measured in n minutes from the anesthesia induction until placement of the stent.	Intraoperative
Secondary	Lasing time	Measured in minutes and defined as the time the laser was in use, not including pedal pauses.	Intraoperative
Secondary	Total energy used	Measured in kilojoules, defined as energy used to fragment the stones into small pieces (=2 mm).	Intraoperative
Secondary	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
Secondary	Number of times the laser pedals are pressed	Measured as a numerical value, defined as number of left, right, and total pedal presses	Intraoperative
Secondary	Percentage of Patients with Post-op Complications	Percentage of patients that results with a post-op complication	4 weeks