Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser for Ureteroscopic Management of Kidney Stones
1 other identifier
interventional
174
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2022
CompletedFirst Submitted
Initial submission to the registry
October 25, 2022
CompletedFirst Posted
Study publicly available on registry
October 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
August 7, 2024
August 1, 2024
3.8 years
October 25, 2022
August 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Procedural Time
Measured in number of minutes from the insertion of the ureteroscope to the removal of the ureteroscope.
Intraoperative
Secondary Outcomes (7)
Stone Free Rate (SFR)
4 and 12 weeks post-op
Total operative time
Intraoperative
Lasing time
Intraoperative
Total energy used
Intraoperative
Laser efficiency
Intraoperative
- +2 more secondary outcomes
Study Arms (2)
Thulium Fibre Laser (TFL)
EXPERIMENTALPatients randomized to this arm will undergo treatment using the TFL.
MOSES Holmium Laser
EXPERIMENTALPatients randomized to this arm will undergo treatment using the MOSES Holmium laser.
Interventions
Participants will undergo treatment using the MOSES Holmium laser.
Eligibility Criteria
You may qualify if:
- years of age and over at the time of enrollment.
- Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx.
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
You may not qualify if:
- Patients with ipsilateral distal ureteral stones or stricture.
- Stone size \> 20 mm or multiple kidney stones in different calyces.
- Previous shock wave lithotripsy (SWL) treatment for the same stone.
- Participants with active urinary tract infection until appropriately treated
- Uncorrected coagulopathy (anticoagulants or blood thinners which cannot be withheld before surgery).
- Pregnancy.
- Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
- Participants who are uncooperative or cannot follow instructions.
- Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent.
- Patients with solitary kidney.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hazem Elmansy, MD
Urologist
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2022
First Posted
October 28, 2022
Study Start
August 16, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
August 7, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share