NCT04556201

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

September 7, 2020

Last Update Submit

October 31, 2023

Conditions

Kidney StoneUreteral Stone

Outcome Measures

Primary Outcomes (1)

  • Stone free rate

    Stone free rate as determined by standard of care imaging

    3 month

Secondary Outcomes (6)

  • Total laser energy time

    During procedure

  • Total procedure time

    During procedure

  • Accessory devices used

    During procedure

  • Adverse events

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

  • Device deficiencies

    During procedure

  • +1 more secondary outcomes

Study Arms (1)

Thulium Fiber Laser lithotripsy

EXPERIMENTAL

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

Device: SOLTIVE™ Premium SuperPulsed Laser Fiber System

Interventions

SOLTIVE™ Premium SuperPulsed Laser Fiber SystemDEVICE

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

Thulium Fiber Laser lithotripsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Mount Sinai West

New York, New York, 10029, United States

Location

Ohio State Wexner Medical Center

Columbus, Ohio, 43212, United States

Location

University Southern Denmark

Fredericia, 7000, Denmark

Location

Hospital CUF Descobertas

Lisbon, 1998-018, Portugal

Location

Related Publications (16)

  • 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.

    PMID: 28213860RESULT

  • 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.

    PMID: 22498635RESULT

  • C. Türk, A. Skolarikos, A. Neisius, A. Petrik, C. Seitz, K. Thomas, EAU Guidelines. European Association of Urology (EAU). 2019.

    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.

    PMID: 27238616RESULT

  • 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.

    PMID: 31476349RESULT

  • Peter Kronenberg, Olivier Traxer. V1718 laser fibers, pulse energy and retropulsion- what we can see and what we can´t. ResearchGate. 2013.

    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.

    PMID: 29253579RESULT

  • 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.

    PMID: 11743269RESULT

  • Zarrabi A, Gross AJ. The evolution of lasers in urology. Ther Adv Urol. 2011 Apr;3(2):81-9. doi: 10.1177/1756287211400494.

    PMID: 21869908RESULT

  • 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.

    PMID: 29774438RESULT

  • 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.

    PMID: 30729311RESULT

  • 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.

    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.

    PMID: 14667517RESULT

  • 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.

    PMID: 25432821RESULT

  • 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.

    PMID: 32742931RESULT

  • 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.

    PMID: 32108256RESULT

MeSH Terms

Conditions

Kidney CalculiUreterolithiasis

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUreteral Diseases

Study Officials

  • Ben Chew, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Olivier Traxer, MD

    Tenon Hospital, Sorbonne University, Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 21, 2020

Study Start

December 1, 2020

Primary Completion

February 2, 2023

Study Completion

May 30, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Subject data collected during the study after de-identification.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Immediately following publication

Locations

US(5)PT(1)DK(1)