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Kidney StoneNCT04556201

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

A study testing SOLTIVE™ Premium SuperPulsed Laser Fiber System in people with Kidney Stone and Ureteral Stone, run by Olympus Corporation of the Americas at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Kidney Stone, Ureteral Stone
What is being tested?
SOLTIVE™ Premium SuperPulsed Laser Fiber System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
7 sitesin 3 countries
Study dates
1 Dec 2020to 30 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age
  • Medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL
  • Willing and able to provide informed consent
  • Female and of childbearing age with a negative pregnancy test

Who cannot join

  • Contraindicated for uteroscopy, PCNL or mini PCNL as determined by the physician
  • Inability to tolerate anesthesia for any reason
  • Unable or unwilling to provide informed consent
  • Concurrently participating in another competing clinical study
  • Known ureteral stricture
  • Unwilling or unable to return for follow-up

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

United States5 sites

  • Ohio State Wexner Medical Center

    Columbus, Ohio, 43212

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Mount Sinai West

    New York, New York, 10029

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

Other trials in United States

Denmark1 site

  • University Southern Denmark

    Fredericia, 7000

Other trials in Denmark

Portugal1 site

  • Hospital CUF Descobertas

    Lisbon, 1998-018

Other trials in Portugal

About this study

Official title: A Prospective, Multicenter, Post-Market Clinical Registry to Collect Real-World Evidence on the Clinical Performance of the SOLTIVE™ Laser for Treatment of Kidney or Ureteral Stones

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.

Being tested
SOLTIVE™ Premium SuperPulsed Laser Fiber System
Medical subject headings
Kidney Calculi, Ureterolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOLTIVE™ Premium SuperPulsed Laser Fiber SystemDevice

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

Study groups in NCT04556201
Study groupRoleWhat they receive
Thulium Fiber Laser lithotripsyExperimentalSubjects who have a medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL
Receives: Device: SOLTIVE™ Premium SuperPulsed Laser Fiber System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stone free rate

    Stone free rate as determined by standard of care imaging

    Measured: 3 month

Secondary outcomes (6)

  1. Total laser energy time

    Measured from first to last footswitch press in minutes

    Measured: During procedure

  2. Total procedure time

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

    Measured: 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

    Measured: During procedure

  4. Adverse events

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

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

  5. Device deficiencies

    Number of device deficiencies during the procedure

    Measured: 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

    Measured: At 1 month follow-up and 3 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2020
  2. Study start1 Dec 2020
  3. Primary completion2 Feb 2023
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04556201
Sponsor's protocol ID
2020-URO-01
Status last verified
Oct 2023
First submitted
7 Sep 2020
Last updated
1 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Subject data collected during the study after de-identification.

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

Questions about this trial

What is this clinical trial studying?

A study testing SOLTIVE™ Premium SuperPulsed Laser Fiber System in people with Kidney Stone and Ureteral Stone, run by Olympus Corporation of the Americas at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Denmark, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stone free rate (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04556201, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.

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