Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)
NCT ID: NCT06721975
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2024-08-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparing Super Pulse Fiber Thulium Laser and Holmium Laser for Ureteral Stone Fragmentation During Ureteroscopy
NCT06667557
Thulium Fiber Laser Prospective Trial
NCT05814133
New Laser and Suction Sheath for Kidney Stone Treatment
NCT06667466
Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease
NCT06306222
Thulium vs. Hol:YAG Laser
NCT05808257
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
1. p-Tm:YAG laser system
2. TFL laser system
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
p-Tm:YAG laser system
This is a new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG)
Thulio pulsed Thulium:YAG (p-Tm:YAG)
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.
TFL laser system
The thulium fiber laser (TFL) has demonstrated effectiveness in this procedure.
Thulium Laser Fiber (TFL)
The thulium fiber laser (TFL) has demonstrated effectiveness in this procedure
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Thulio pulsed Thulium:YAG (p-Tm:YAG)
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.
Thulium Laser Fiber (TFL)
The thulium fiber laser (TFL) has demonstrated effectiveness in this procedure
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dornier MedTech Systems
INDUSTRY
University of California, San Diego
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Roger L Sur, M.D.
Professor of Urology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Diego
San Diego, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
314954-00001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
810115
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.