Clinical trial NCT06721975: Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)
Official title: Prospective Single-center Study Comparing Thulium Fiber Laser to Pulsed Thulium:YAG Laser in the Ureteroscopic Treatment of Nephrolithiasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Stones
Nephrolithiasis
Keywords: laser lithotripsy
laser
nephrolithiasis
kidney stone
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Dornier MedTech Systems
First posted: 2024-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient will be randomized to one of the following two groups:

1. p-Tm:YAG laser system
2. TFL laser system
Primary purpose: TREATMENT

Brief summary: This research study is being conducted to assess the ability and efficiency of two laser systems to break up kidney stones during ureteroscopy with laser lithotripsy for kidney stone treatment.

Detailed description: Ureteroscopic stone treatment is a minimally invasive procedure commonly performed for kidney stones. Recently, the thulium fiber laser (TFL) has demonstrated effectiveness in this procedure. A new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG ) is beginning to be studied in vitro and in vivo. Dornier Thulio p-Tm:YAG may represent an attractive new laser platform, with comparable properties to TFL including decreased retropulsion, smaller dust, and improved ablation efficiency relative to Ho:YAG. Moreover, the p-Tm:YAG laser has been shown to be effective in treating a wide range of human stone types. The Dornier Thulio p-Tm:YAG laser has been tested clinically in a limited fashion via pilot studies in URS and the RevoLix Hybrid Thulium Laset (HTL) was studied in mini-PCNL. However, limited research has directly compared its efficacy and safety and no prospective comparative trials have been published.

This study aims to investigate whether Dornier Thulio p-Tm:YAG laser is non-inferior to TFL in terms of dusting ablation efficiency (J/mm3) and dusting ablation speed (mm3/s) for ureteroscopic stone treatment. To our knowledge no large-scale study has examined the outcomes of p-Tm:YAG compared to TFL for the treatment of kidney stones which warrants an investigation giving the promising results previously reported.

The primary objective is to assess stone dusting ablation efficiency (Joules/stone volume ablated) between both laser systems in vivo for ureteroscopic stone treatment . Secondary objectives include assessing stone dusting ablation speed (stone volume ablated/lasing time) and complication profile of both laser systems.

The investigators hypothesize that dusting ablation efficiency and speed of the p-Tm:YAG laser will be non-inferior to TFL for the treatment of renal stones totaling 7-20 mm in diameter with similar clinical and safety/complication outcomes.

Eligibility criteria: Inclusion Criteria:

* Solitary renal stone 7 to 20 mm in size or in the case of multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) of 7-20 mm is required
* Must be a suitable operative candidate for flexible ureteroscopy per American Urological Association guidelines
* Must be able to give consent
* Bilateral ureteroscopy will be permitted but only the first side (per surgeon discretion) will be included in the study
* Surgeons participating in the study must be urological attending surgeons or fellows with subspecialty training in Endourology

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 UTI

Primary outcomes:
measure: The amount of energy used per given stone volume
timeFrame: From enrollment to the follow up imaging at 6-12 weeks
Secondary outcomes:
measure: Laser ablation speed (volume of stone/lasing time = mm3/sec)
timeFrame: From enrollment to the follow up imaging at 6-12 weeks
measure: Post-operative complications compared between the two laser systems
timeFrame: From enrollment to the follow up imaging at 6-12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
citation: Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014 Dec 19;14:135. doi: 10.1186/1471-2288-14-135.
citation: Ventimiglia E, Robesti D, Bevilacqua L, Tondelli E, Oliva I, Orecchia L, Juliebo-Jones P, Pietropaolo A, De Coninck V, Esperto F, Tailly T, Ferretti S, Gauhar V, Somani B, Villa L, Keller EX, Salonia A, Traxer O, Kartalas Goumas I. What to expect from the novel pulsed thulium:YAG laser? A systematic review of endourological applications. World J Urol. 2023 Nov;41(11):3301-3308. doi: 10.1007/s00345-023-04580-z. Epub 2023 Sep 8.
citation: Ventimiglia E, Pauchard F, Gorgen ARH, Panthier F, Doizi S, Traxer O. How do we assess the efficacy of Ho:YAG low-power laser lithotripsy for the treatment of upper tract urinary stones? Introducing the Joules/mm3 and laser activity concepts. World J Urol. 2021 Mar;39(3):891-896. doi: 10.1007/s00345-020-03241-9. Epub 2020 May 27.
citation: Vaddi CM, Ramakrishna P, Ganeshan S, Swamy S, Anandan H, Babu M, Panda R. The clinical efficiency and safety of 60W superpulse thulium fiber laser in retrograde intrarenal surgery. Indian J Urol. 2022 Jul-Sep;38(3):191-196. doi: 10.4103/iju.iju_60_22. Epub 2022 Jul 1.
citation: Taratkin M, Azilgareeva C, Korolev D, Barghouthy Y, Tsarichenko D, Akopyan G, Chinenov D, Ali S, Kozlov V, Mikhailov V, Enikeev D. Prospective Single-Center Study of SuperPulsed Thulium Fiber Laser in Retrograde Intrarenal Surgery: Initial Clinical Data. Urol Int. 2022;106(4):404-410. doi: 10.1159/000516933. Epub 2021 Jun 16.
citation: Stern KL, Borgert BJ, Wolf JS Jr. Steerable Ureteroscopic Renal Evacuation (SURE) for Large Renal Stones: A Multi-Institutional Center Study. J Endourol. 2023 Aug 28;37(11):1179-83. doi: 10.1089/end.2023.0424. Online ahead of print.
citation: Solano C, Corrales M, Panthier F, Candela L, Doizi S, Traxer O. Navigating urolithiasis treatment: assessing the practicality and performance of thulium fiber laser, holmium YAG, and thulium YAG in real-world scenarios. World J Urol. 2023 Oct;41(10):2627-2636. doi: 10.1007/s00345-023-04487-9. Epub 2023 Jul 20.
citation: Sierra A, Corrales M, Kolvatzis M, Traxer O. Initial clinical experience with the thulium fiber laser from Quanta System: First 50 reported cases. World J Urol. 2022 Oct;40(10):2549-2553. doi: 10.1007/s00345-022-04096-y. Epub 2022 Jul 21.
citation: Petzold R, Suarez-Ibarrola R, Miernik A. Temperature Assessment of a Novel Pulsed Thulium Solid-State Laser Compared with a Holmium:Yttrium-Aluminum-Garnet Laser. J Endourol. 2021 Jun;35(6):853-859. doi: 10.1089/end.2020.0803. Epub 2020 Dec 3.
citation: Petzold R, Suarez-Ibarrola R, Miernik A. Gas Bubble Anatomy During Laser Lithotripsy: An Experimental In Vitro Study of a Pulsed Solid-State Tm:YAG and Ho:YAG Device. J Endourol. 2021 Jul;35(7):1051-1057. doi: 10.1089/end.2020.0526. Epub 2020 Dec 22.
citation: Petzold R, Miernik A, Suarez-Ibarrola R. Retropulsion force in laser lithotripsy-an in vitro study comparing a Holmium device to a novel pulsed solid-state Thulium laser. World J Urol. 2021 Sep;39(9):3651-3656. doi: 10.1007/s00345-021-03668-8. Epub 2021 Mar 23.
citation: Petzold R, Miernik A, Suarez-Ibarrola R. In Vitro Dusting Performance of a New Solid State Thulium Laser Compared to Holmium Laser Lithotripsy. J Endourol. 2021 Feb;35(2):221-225. doi: 10.1089/end.2020.0525. Epub 2020 Sep 9.
citation: Patil A, Reddy N, Shah D, Singh A, Ganpule A, Sabnis R, Desai M. High-Power Holmium with MOSES Technology or Thulium Fiber Laser in MiniPerc with Suction: A New Curiosity. J Endourol. 2022 Oct;36(10):1348-1354. doi: 10.1089/end.2021.0915. Epub 2022 Aug 17.
citation: Panthier F, Solano C, Chicaud M, Kutchukian S, Candela L, Doizi S, Corrales M, Traxer O. Initial clinical experience with the pulsed solid-state thulium YAG laser from Dornier during RIRS: first 25 cases. World J Urol. 2023 Aug;41(8):2119-2125. doi: 10.1007/s00345-023-04501-0. Epub 2023 Jul 6.
citation: Negida A. Sample Size Calculation Guide - Part 6: How to calculate the sample size for a non-inferiority or an equivalence clinical trial. Adv J Emerg Med. 2019 Nov 27;4(1):e15. doi: 10.22114/ajem.v0i0.302. eCollection 2020 Winter. No abstract available.
citation: Kwok JL, Ventimiglia E, De Coninck V, Corrales M, Sierra A, Panthier F, Pauchard F, Schmid F, Hunziker M, Poyet C, Daudon M, Traxer O, Eberli D, Keller EX. Pulsed thulium:YAG laser-ready to dust all urinary stone composition types? Results from a PEARLS analysis. World J Urol. 2023 Oct;41(10):2823-2831. doi: 10.1007/s00345-023-04549-y. Epub 2023 Aug 16.
citation: Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018 Jun;27(6):1785-1805. doi: 10.1177/0962280216669183. Epub 2016 Sep 27.
citation: Kraft L, Yilmaz M, Petzold R, Gratzke C, Suarez-Ibarrola R, Miernik A. Dusting Efficiency of a Novel Pulsed Thulium:Yttrium Aluminum Garnet Laser vs a Thulium Fiber Laser. J Endourol. 2022 Feb;36(2):259-265. doi: 10.1089/end.2021.0441. Epub 2021 Nov 16.
citation: Kraft L, Petzold R, Suarez-Ibarrola R, Miernik A. In vitro fragmentation performance of a novel, pulsed Thulium solid-state laser compared to a Thulium fibre laser and standard Ho:YAG laser. Lasers Med Sci. 2022 Apr;37(3):2071-2078. doi: 10.1007/s10103-021-03495-8. Epub 2021 Dec 14.
citation: Korolev D, Akopyan G, Tsarichenko D, Shpikina A, Ali S, Chinenov D, Corrales M, Taratkin M, Traxer O, Enikeev D. Minimally invasive percutaneous nephrolithotomy with SuperPulsed Thulium-fiber laser. Urolithiasis. 2021 Oct;49(5):485-491. doi: 10.1007/s00240-021-01258-2. Epub 2021 Mar 3.
citation: Huusmann S, Lafos M, Meyenburg I, Muschter R, Teichmann HO, Herrmann T. Tissue effects of a newly developed diode pumped pulsed Thulium:YAG laser compared to continuous wave Thulium:YAG and pulsed Holmium:YAG laser. World J Urol. 2021 Sep;39(9):3503-3508. doi: 10.1007/s00345-021-03634-4. Epub 2021 Mar 16.
citation: Haas CR, Knoedler MA, Li S, Gralnek DR, Best SL, Penniston KL, Nakada SY. Pulse-modulated Holmium:YAG Laser vs the Thulium Fiber Laser for Renal and Ureteral Stones: A Single-center Prospective Randomized Clinical Trial. J Urol. 2023 Feb;209(2):374-383. doi: 10.1097/JU.0000000000003050. Epub 2023 Jan 9.
citation: Flight L, Julious SA. Practical guide to sample size calculations: non-inferiority and equivalence trials. Pharm Stat. 2016 Jan-Feb;15(1):80-9. doi: 10.1002/pst.1716. Epub 2015 Nov 25.
citation: Enikeev D, Grigoryan V, Fokin I, Morozov A, Taratkin M, Klimov R, Kozlov V, Gabdullina S, Glybochko P. Endoscopic lithotripsy with a SuperPulsed thulium-fiber laser for ureteral stones: A single-center experience. Int J Urol. 2021 Mar;28(3):261-265. doi: 10.1111/iju.14443. Epub 2020 Nov 30.
citation: Corrales M, Traxer O. Retrograde intrarenal surgery: laser showdown (Ho:YAG vs thulium fiber laser). Curr Opin Urol. 2022 Mar 1;32(2):179-184. doi: 10.1097/MOU.0000000000000971.
citation: Bergmann J, Rosenbaum CM, Netsch C, Gross AJ, Becker B. First Clinical Experience of a Novel Pulsed Solid-State Thulium:YAG Laser during Percutaneous Nephrolithotomy. J Clin Med. 2023 Mar 29;12(7):2588. doi: 10.3390/jcm12072588.
citation: Azilgareeva, C., Taratkin, M., Petov, V., Korolev, D., Akopyan, G., Dymov, A., et al. (2022). Prospective randomized comparison of SP TFL and Ho:YAG in RIRS for kidney stones: a single-center study. Eur. Urol. 81, S1722-S1723. doi: 10.1016/S0302-2838(22)01252-0.
citation: Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.