Clinical trial NCT05814133: Thulium Fiber Laser Prospective Trial
Official title: Prospective Clinical Trial To Evaluate The Thulium Fiber Laser For The Ureteroscopic Treatment Of Nephrolithiasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Stone
Keywords: ureteroscopy
lithotripsy
thulium fiber laser
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: Columbia University
name: University of California, San Diego
name: Mayo Clinic
name: Ohio State University
name: Vanderbilt University
name: The Cleveland Clinic
First posted: 2023-04-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Mean total operative time
timeFrame: during the procedure
Secondary outcomes:
measure: Rate of stone retropulsion
timeFrame: during the procedure
Other outcomes:
measure: Mean length of hospitalization
timeFrame: From day and time of admission to day and time of discharge
measure: Rate of postoperative complications
timeFrame: at 6 weeks
measure: Rate of stone free status
timeFrame: at 6 weeks
measure: Rate of need for ancillary procedures
timeFrame: at 6 weeks
measure: Mean perceived workload score
timeFrame: immediately after the procedure
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Naeem Bhojani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.