Thulium Fiber Laser Prospective Trial

Kidney Stone Clinical Trial

— TFL  

Official title:

Prospective Clinical Trial To Evaluate The Thulium Fiber Laser For The Ureteroscopic Treatment Of Nephrolithiasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814133
• Other study ID #: 2023-11370
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: July 15, 2025

Study information

• Verified date: January 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Naeem Bhojani, M.D
• Phone: 5148908000
• Email: naeem.bhojani[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec

Sponsors (8)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Columbia University, Mayo Clinic, Ohio State University, The Cleveland Clinic, University of British Columbia, University of California, San Diego, Vanderbilt University

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean length of hospitalization	Length of hospitalization (in days) for the procedure will be recorded for each patient	From day and time of admission to day and time of discharge
Other	Rate of postoperative complications	Medical chart review will be done to assess the occurence of post-operative complications	at 6 weeks
Other	Rate of stone free status	Post-operative CT imaging will be reviewed to assess the occurence of ''stone free status''	at 6 weeks
Other	Rate of need for ancillary procedures	Medical chart review will be done to assess the occurence of an additional ureteroscopy need to treat patients	at 6 weeks
Other	Mean perceived workload score	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.	immediately after the procedure
Primary	Mean total operative time	Total operative time during the ureteroscopic treatment of renal stones using a laser dusting technique.	during the procedure
Secondary	Rate of stone retropulsion	Review of the procedure video recording to assess stone retropulsion occurence during stone lithotripsy	during the procedure

External Links

•   Chew * Ben H., Knudsen BE, Molina WR. Mp79-19 comparison of dusting and fragmenting using the new super pulse thulium fiber laser to a 120w holmium:yag laser. Journal of Urology. 2019 Apr;201(Supplement 4):e1159-60.