Using Thulium Fiber Laser for Kidney Stone Treatment
Prospective Clinical Trial To Evaluate The Thulium Fiber Laser For The Ureteroscopic Treatment Of Nephrolithiasis
This study is testing a new Thulium Fiber Laser treatment for kidney stones to see if it works better than the standard laser method for breaking up stones and helping patients recover.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05814133 on ClinicalTrials.gov |
What this trial studies
This multi-center clinical trial evaluates the effectiveness of the Thulium Fiber Laser (TFL) for lithotripsy in patients with kidney stones sized between 8 to 20 mm. The study aims to compare TFL's performance against the established Holmium: YAG laser, focusing on its efficiency in stone fragmentation, dusting capacity, and overall treatment time. Eligible participants will undergo flexible ureteroscopy, and the trial will assess outcomes related to stone removal and patient recovery. The research is being conducted across multiple institutions, including the Centre hospitalier de l'Université de Montréal.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with solitary renal stones measuring 8 to 20 mm.
Not a fit: Patients with ureteral stones, prior reconstructive procedures, or untreated urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and efficient treatment options for patients with kidney stones.
How similar studies have performed: While the Holmium: YAG laser is the current standard, the Thulium Fiber Laser represents a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Solitary renal stone 8 to 20 mm in size or in the case of multiple stones the conglomerate diameter of 8-20 mm is required * Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines * Must be 18 years or older * Must be able to give consent * Bilateral ureteroscopy will be permitted but only the first side will be included in the study Exclusion Criteria: * Concomitant stones in the ureter * Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture * Prior radiotherapy to the abdomen or pelvis * Neurogenic bladder or spinal cord injury * Pregnancy * Untreated Urinary Tract Infection (UTI)
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Naeem Bhojani, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Naeem Bhojani, M.D
- Email: naeem.bhojani@gmail.com
- Phone: 5148908000
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.