Comparing two types of lasers for treating 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 is testing which type of laser, Thulium Fiber or Holmium MOSES, works better and is safer for treating kidney stones in patients with certain sizes and types of stones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thunder Bay Regional Health Research Institute Academic / other |
| Locations | 1 site (Thunder Bay, Ontario) |
| Trial ID | NCT05598645 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of the Thulium Fiber Laser (TFL) and the Holmium MOSES Laser in managing kidney stones that require treatment. With the rising prevalence of kidney stones and a high recurrence risk, this research seeks to determine which laser technology offers better outcomes. The study will involve patients with single kidney stones between 10-20 mm in size or multiple stones in a single calyx, assessing both the effectiveness and safety of each laser type during the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over with single kidney stones measuring 10-20 mm or multiple stones in a single calyx.
Not a fit: Patients with larger stones, multiple stones in different calyces, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from kidney stones, potentially reducing recurrence rates and enhancing recovery.
How similar studies have performed: While Holmium lasers are considered the gold standard, the TFL is a newer technology, making this comparison novel and potentially groundbreaking.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Thunder Bay, Ontario
- Thunder Bay Regional Health Sciences Centre — Thunder Bay, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Hazem Elmansy, MD — Urologist
- Study coordinator: Shalyn Littlefield, MSc
- Email: shalyn.littlefield@tbh.net
- Phone: (807) 684-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.