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The purpose of this study is to collect real-world evidence on the performance of the SOLTIVE™ Premium SuperPulsed Laser System for laser lithotripsy in ureteroscopy, percutaneous nephrolithotomy (PCNL) and mini PCNL for kidney and ureteral stones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thulium Fiber Laser lithotripsy | Experimental | Subjects who have a medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOLTIVE™ Premium SuperPulsed Laser Fiber System | Device | SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone free rate | Stone free rate as determined by standard of care imaging | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Total laser energy time | Measured from first to last footswitch press in minutes | During procedure |
| Total procedure time | Measured from time of initial ureteroscope insertion to time of ureteroscope withdrawal in minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Chew, MD | University of British Columbia | Principal Investigator |
| Olivier Traxer, MD | Tenon Hospital, Sorbonne University, Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| Loma Linda University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28213860 | Result | Sorokin I, Mamoulakis C, Miyazawa K, Rodgers A, Talati J, Lotan Y. Epidemiology of stone disease across the world. World J Urol. 2017 Sep;35(9):1301-1320. doi: 10.1007/s00345-017-2008-6. Epub 2017 Feb 17. | |
| 22498635 | Result | Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31. |
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Subject data collected during the study after de-identification.
Immediately following publication
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| During procedure |
| Accessory devices used | Types of accessory devices used during the procedure (ureteroscopy, PCNL or mini-PCNL) and the total time used during the procedure in minutes | During procedure |
| Adverse events | AEs related to device or procedure and non-serious AEs related to device or procedure | At procedure, immediate post-procedure, 1 month follow-up and 3 month follow-up |
| Device deficiencies | Number of device deficiencies during the procedure | During procedure |
| Rate of treatment/interventions needed | Types of treatments and/or interventions needed post-procedure at the follow-up visits and the number of times treatments and/or interventions were performed | At 1 month follow-up and 3 month follow-up |
| Loma Linda |
| California |
| 92354 |
| United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Mount Sinai West | New York | New York | 10029 | United States |
| Ohio State Wexner Medical Center | Columbus | Ohio | 43212 | United States |
| University Southern Denmark | Fredericia | 7000 | Denmark |
| Hospital CUF Descobertas | Lisbon | 1998-018 | Portugal |
| Result | C. Türk, A. Skolarikos, A. Neisius, A. Petrik, C. Seitz, K. Thomas, EAU Guidelines. European Association of Urology (EAU). 2019. |
| 27238616 | Result | 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. |
| 31476349 | Result | Aldoukhi AH, Knudsen BE, Black KM, Hall TL, Roberts WW, Ghani KR. Are We Cutting Ourselves Short? Laser Lithotripsy Performance Based on Differences in Fiber-tip Preparation. Urology. 2019 Dec;134:79-83. doi: 10.1016/j.urology.2019.08.027. Epub 2019 Aug 30. |
| Result | Peter Kronenberg, Olivier Traxer. V1718 laser fibers, pulse energy and retropulsion- what we can see and what we can´t. ResearchGate. 2013. |
| 29253579 | Result | Humphreys MR, Shah OD, Monga M, Chang YH, Krambeck AE, Sur RL, Miller NL, Knudsen BE, Eisner BH, Matlaga BR, Chew BH. Dusting versus Basketing during Ureteroscopy-Which Technique is More Efficacious? A Prospective Multicenter Trial from the EDGE Research Consortium. J Urol. 2018 May;199(5):1272-1276. doi: 10.1016/j.juro.2017.11.126. Epub 2017 Dec 16. |
| 11743269 | Result | Sofer M, Watterson JD, Wollin TA, Nott L, Razvi H, Denstedt JD. Holmium:YAG laser lithotripsy for upper urinary tract calculi in 598 patients. J Urol. 2002 Jan;167(1):31-4. doi: 10.1016/s0022-5347(05)65376-1. |
| 21869908 | Result | Zarrabi A, Gross AJ. The evolution of lasers in urology. Ther Adv Urol. 2011 Apr;3(2):81-9. doi: 10.1177/1756287211400494. |
| 29774438 | Result | Kronenberg P, Somani B. Advances in Lasers for the Treatment of Stones-a Systematic Review. Curr Urol Rep. 2018 May 17;19(6):45. doi: 10.1007/s11934-018-0807-y. |
| 30729311 | Result | Traxer O, Keller EX. Thulium fiber laser: the new player for kidney stone treatment? A comparison with Holmium:YAG laser. World J Urol. 2020 Aug;38(8):1883-1894. doi: 10.1007/s00345-019-02654-5. Epub 2019 Feb 6. |
| Result | Scott, N. J., C. M. Cilip, and N. M. Fried. Thulium Fiber Laser Ablation of Urinary Stones Through Small-Core Optical Fibers, IEEE Journal of Selected Topics in Quantum Electronics. 2009;(15):435-40. |
| 14667517 | Result | Pasqui F, Dubosq F, Tchala K, Tligui M, Gattegno B, Thibault P, Traxer O. Impact on active scope deflection and irrigation flow of all endoscopic working tools during flexible ureteroscopy. Eur Urol. 2004 Jan;45(1):58-64. doi: 10.1016/j.eururo.2003.08.013. |
| 25432821 | Result | Kronenberg P, Traxer O. The truth about laser fiber diameters. Urology. 2014 Dec;84(6):1301-7. doi: 10.1016/j.urology.2014.08.017. |
| 32742931 | Result | Mahmood SN, Toffeq H, Fakhralddin S. Sheathless and fluoroscopy-free retrograde intrarenal surgery: An attractive way of renal stone management in high-volume stone centers. Asian J Urol. 2020 Jul;7(3):309-317. doi: 10.1016/j.ajur.2019.07.003. Epub 2019 Jul 16. |
| 32108256 | Result | Enikeev D, Taratkin M, Klimov R, Alyaev Y, Rapoport L, Gazimiev M, Korolev D, Ali S, Akopyan G, Tsarichenko D, Markovina I, Ventimiglia E, Goryacheva E, Okhunov Z, Jefferson FA, Glybochko P, Traxer O. Thulium-fiber laser for lithotripsy: first clinical experience in percutaneous nephrolithotomy. World J Urol. 2020 Dec;38(12):3069-3074. doi: 10.1007/s00345-020-03134-x. Epub 2020 Feb 27. |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053039 | Ureterolithiasis |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014515 | Ureteral Diseases |
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