TFL: Thulium Fiber Laser Prospective Trial
Study Details
Study Description
Brief Summary
This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lithotripsy Ureteroscopy with lithotripsy using the Thulium Fiber Laser |
Device: Thulium 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.
|
Outcome Measures
Primary Outcome Measures
- Mean total operative time [during the procedure]
Total operative time during the ureteroscopic treatment of renal stones using a laser dusting technique.
Secondary Outcome Measures
- Rate of stone retropulsion [during the procedure]
Review of the procedure video recording to assess stone retropulsion occurence during stone lithotripsy
Other Outcome Measures
- 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 postoperative complications [at 6 weeks]
Medical chart review will be done to assess the occurence of post-operative complications
- Rate of stone free status [at 6 weeks]
Post-operative CT imaging will be reviewed to assess the occurence of ''stone free status''
- 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
- 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.
Eligibility Criteria
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
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Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines
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Must be 18 years or older
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Must be able to give consent
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Bilateral ureteroscopy will be permitted but only the first side will be included in the study
Exclusion Criteria:
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Concomitant stones in the ureter
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Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
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Prior radiotherapy to the abdomen or pelvis
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Neurogenic bladder or spinal cord injury
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Pregnancy
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Untreated Urinary Tract Infection (UTI)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | Canada | H2X 0A9 |
Sponsors and Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
- University of British Columbia
- Columbia University
- University of California, San Diego
- Mayo Clinic
- Ohio State University
- Vanderbilt University
- The Cleveland Clinic
Investigators
- Principal Investigator: Naeem Bhojani, MD, Centre hospitalier de l'Université de Montréal (CHUM)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Khusid JA, Khargi R, Seiden B, Sadiq AS, Atallah WM, Gupta M. Thulium fiber laser utilization in urological surgery: A narrative review. Investig Clin Urol. 2021 Mar;62(2):136-147. doi: 10.4111/icu.20200467.
- Kronenberg P, Hameed BZ, Somani B. Outcomes of thulium fibre laser for treatment of urinary tract stones: results of a systematic review. Curr Opin Urol. 2021 Mar 1;31(2):80-86. doi: 10.1097/MOU.0000000000000853.
- Kronenberg P, Traxer O. Update on lasers in urology 2014: current assessment on holmium:yttrium-aluminum-garnet (Ho:YAG) laser lithotripter settings and laser fibers. World J Urol. 2015 Apr;33(4):463-9. doi: 10.1007/s00345-014-1395-1. Epub 2014 Sep 4.
- Law KE, Lowndes BR, Kelley SR, Blocker RC, Larson DW, Hallbeck MS, Nelson H. NASA-Task Load Index Differentiates Surgical Approach: Opportunities for Improvement in Colon and Rectal Surgery. Ann Surg. 2020 May;271(5):906-912. doi: 10.1097/SLA.0000000000003173.
- Nazif OA, Teichman JM, Glickman RD, Welch AJ. Review of laser fibers: a practical guide for urologists. J Endourol. 2004 Nov;18(9):818-29. doi: 10.1089/end.2004.18.818.
- Traxer O, Corrales M. Managing Urolithiasis with Thulium Fiber Laser: Updated Real-Life Results-A Systematic Review. J Clin Med. 2021 Jul 30;10(15):3390. doi: 10.3390/jcm10153390.
- 2023-11370