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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Stone
• Intervention / Treatment: Device: Thulium Fibre Laser; Device: MOSES Holmium Laser

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shalyn Littlefield, MSc; Phone Number: (807) 684-6000; Email: shalyn.littlefield@tbh.net
• Study Contact Backup: Name: Hazem Elmansy, MD; Phone Number: (807) 684-6000; Email: elmansyh@tbh.net

Study Locations

• Canada
  • Ontario
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Recruiting
      • Thunder Bay Regional Health Sciences Centre
      • Contact: Shalyn Littlefield, MSc; Email: shalyn.littlefield@tbh.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thulium Fibre Laser (TFL); Patients randomized to this arm will undergo treatment using the TFL.	Device: Thulium Fibre Laser; Participants will undergo treatment using the TFL
Experimental: MOSES Holmium Laser; Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.	Device: MOSES Holmium Laser; Participants will undergo treatment using the MOSES Holmium laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Time	Measured in number of minutes from the insertion of the ureteroscope to the removal of the ureteroscope.	Intraoperative

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Thunder Bay Regional Health Research Institute
• Investigators: Principal Investigator: Hazem Elmansy, MD, Urologist

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: RP-791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No