Kidney Stone
Conditions
Keywords
ureteroscopy, lithotripsy, thulium fiber laser
Brief summary
This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.
Detailed description
Flexible ureteroscopy is considered the first-line therapy for renal stones \< 2 cm. The Holmium: YAG laser (Ho:YAG) is established as gold standard in urology practice. Despite its limitations, it is widely used to break stones into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the 'Thulium Fiber Laser' (TFL) with unique characteristics and promising improvements of ablation efficiency, dusting capacity, operating time and deflection. A a multi-center, prospective clinical trial to further assess those advantages for the lithotripsy of kidney stones will be conducted.
Interventions
DEVICEThulium Fiber Laser
Thulium Fiber Laser will be used to break renal stones \< 2 cm into fragments small enough to remove or pass spontaneously through the ureter.
Sponsors
University of British Columbia
Columbia University
University of California, San Diego
Mayo Clinic
Ohio State University
Vanderbilt University
The Cleveland Clinic
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean total operative time | during the procedure | Total operative time during the ureteroscopic treatment of renal stones using a laser dusting technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of stone retropulsion | during the procedure | Review of the procedure video recording to assess stone retropulsion occurence during stone lithotripsy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of need for ancillary procedures | at 6 weeks | Medical chart review will be done to assess the occurence of an additional ureteroscopy need to treat patients |
| Rate of postoperative complications | at 6 weeks | Medical chart review will be done to assess the occurence of post-operative complications |
| Mean perceived workload score | immediately after the procedure | Effects of TFL technology on reducing surgeon perceived workload will be assessed by completing the National Aeronautics and Space Administration (NASA) Task Load Index. The tool allows to determine the subjective mental workload (MWL) of a participant while they are performing a task.The participants self-rate on a scale of 1 (low) to 20 (high). The higher the score, the worst is the outcome. |
| Mean length of hospitalization | From day and time of admission to day and time of discharge | Length of hospitalization (in days) for the procedure will be recorded for each patient |
| Rate of stone free status | at 6 weeks | Post-operative CT imaging will be reviewed to assess the occurence of ''stone free status'' |
Countries
Canada
Contacts
Primary ContactNaeem Bhojani, M.D
Backup ContactKahina Bensaadi, DESS
Outcome results
None listed