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

Kidney Stone Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556201
• Other study ID #: 2020-URO-01
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: October 2023
• Source: Olympus Corporation of the Americas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 30, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stone
• Ureteral Calculi
• Ureteral Stone
• Ureterolithiasis

Intervention

Device:
• SOLTIVE™ Premium SuperPulsed Laser Fiber System
SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only

Locations

Country	Name	City	State
Denmark	University Southern Denmark	Fredericia
Portugal	Hospital CUF Descobertas	Lisboa
United States	Ohio State Wexner Medical Center	Columbus	Ohio
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Mount Sinai West	New York	New York
United States	Mayo Clinic Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Corporation of the Americas

Countries where clinical trial is conducted

United States,  Denmark,  Portugal, 

References & Publications (16)

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 3 — View Citation

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. 201 — View Citation

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

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 ex — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 J — View Citation

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 — View Citation

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

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rate	Stone free rate as determined by standard of care imaging	3 month
Secondary	Total laser energy time	Measured from first to last footswitch press in minutes	During procedure
Secondary	Total procedure time	Measured from time of initial ureteroscope insertion to time of ureteroscope withdrawal in minutes	During procedure
Secondary	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
Secondary	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
Secondary	Device deficiencies	Number of device deficiencies during the procedure	During procedure
Secondary	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