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CompletedNCT04556201Updated Nov 1, 2023

The Performance of the SOLTIVE Laser System for Laser Lithotripsy in Kidney or Ureteral Stones

An interventional study of SOLTIVE™ Premium SuperPulsed Laser Fiber System in Kidney Stone and Ureteral Stone, sponsored by Olympus Corporation of the Americas. Completed at 7 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.

Sponsored by Olympus Corporation of the Americas · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Kidney Stone
  • Ureteral Stone
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. ≥18 years of age
  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

Exclusion Criteria:

  1. Contraindicated for uteroscopy, PCNL or mini PCNL as determined by the physician
  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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
450 participants (actual)

Study arms

  • Experimental
    Thulium Fiber Laser lithotripsy

    Subjects who have a medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL

    Device: SOLTIVE™ Premium SuperPulsed Laser Fiber System

Interventions

  • DeviceSOLTIVE™ Premium SuperPulsed Laser Fiber System

    SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only

05

What researchers measure

Primary outcomes

  1. Stone free rate

    Stone free rate as determined by standard of care imaging

    Time frame: 3 month

Secondary outcomes

  1. Total laser energy time

    Measured from first to last footswitch press in minutes

    Time frame: During procedure

  2. Total procedure time

    Measured from time of initial ureteroscope insertion to time of ureteroscope withdrawal in minutes

    Time frame: During procedure

  3. 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

    Time frame: During procedure

  4. Adverse events

    AEs related to device or procedure and non-serious AEs related to device or procedure

    Time frame: At procedure, immediate post-procedure, 1 month follow-up and 3 month follow-up

  5. Device deficiencies

    Number of device deficiencies during the procedure

    Time frame: During procedure

  6. 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

    Time frame: At 1 month follow-up and 3 month follow-up

06

Study locations

7 sites
  • Mayo Clinic Arizona
    Phoenix, Arizona 85054, United States
  • Loma Linda University Medical Center
    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
    Lisboa, 1998-018, Portugal
07

References and documents

Publications

  • 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. PubMed 28213860 ↗
  • 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. PubMed 22498635 ↗
  • 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. PubMed 27238616 ↗
  • 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. PubMed 31476349 ↗
  • 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. PubMed 29253579 ↗
  • 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. PubMed 11743269 ↗
  • Zarrabi A, Gross AJ. The evolution of lasers in urology. Ther Adv Urol. 2011 Apr;3(2):81-9. doi: 10.1177/1756287211400494. PubMed 21869908 ↗
  • 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. PubMed 29774438 ↗
  • 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. PubMed 30729311 ↗
  • 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. PubMed 14667517 ↗
  • 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. PubMed 25432821 ↗
  • 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. PubMed 32742931 ↗
  • 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. PubMed 32108256 ↗

Individual participant data

Plan to share: Yes — Subject data collected during the study after de-identification.

Supporting information: Study protocol, Csr

08

Registry details

Key details

Study ID
NCT04556201
Lead sponsor
Olympus Corporation of the Americas
Responsible party
Sponsor
First posted
Sep 21, 2020
Start date
Dec 1, 2020
Primary completion
Feb 2, 2023
Completion
May 30, 2023
Last update
Nov 1, 2023

Study contacts

Ben Chew, MD
principal investigator · University of British Columbia
Olivier Traxer, MD
principal investigator · Tenon Hospital, Sorbonne University, Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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