The Performance of the SOLTIVE Laser System for Laser Lithotripsy in Kidney or Ureteral Stones
NCT ID: NCT04556201
Last Updated: 2023-11-01
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
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COMPLETED
NA
450 participants
INTERVENTIONAL
2020-12-01
2023-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Thulium Fiber Laser lithotripsy
Subjects who have a medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL
SOLTIVE™ Premium SuperPulsed Laser Fiber System
SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only
Interventions
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SOLTIVE™ Premium SuperPulsed Laser Fiber System
SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only
Eligibility Criteria
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Inclusion Criteria
2. Medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL
3. Willing and able to provide informed consent
4. Female and of childbearing age with a negative pregnancy test
Exclusion Criteria
2. Inability to tolerate anesthesia for any reason
3. Unable or unwilling to provide informed consent
4. Concurrently participating in another competing clinical study
5. Known ureteral stricture
6. Unwilling or unable to return for follow-up
18 Years
ALL
Yes
Sponsors
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Olympus Corporation of the Americas
INDUSTRY
Responsible Party
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Principal Investigators
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Ben Chew, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Olivier Traxer, MD
Role: PRINCIPAL_INVESTIGATOR
Tenon Hospital, Sorbonne University, Paris
Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Mount Sinai West
New York, New York, United States
Ohio State Wexner Medical Center
Columbus, Ohio, United States
University Southern Denmark
Fredericia, , Denmark
Hospital CUF Descobertas
Lisbon, , Portugal
Countries
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References
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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.
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.
C. Türk, A. Skolarikos, A. Neisius, A. Petrik, C. Seitz, K. Thomas, EAU Guidelines. European Association of Urology (EAU). 2019.
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.
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.
Peter Kronenberg, Olivier Traxer. V1718 laser fibers, pulse energy and retropulsion- what we can see and what we can´t. ResearchGate. 2013.
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.
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.
Zarrabi A, Gross AJ. The evolution of lasers in urology. Ther Adv Urol. 2011 Apr;3(2):81-9. doi: 10.1177/1756287211400494.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2020-URO-01
Identifier Type: -
Identifier Source: org_study_id
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