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OpenTrials
Completed

NCT Number: NCT04556201

The Performance of the SOLTIVE Laser System for Laser Lithotripsy in 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.

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Key information

Conditions

Kidney Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ureteral Diseases Ureteral Stone Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Southern Denmark, Fredericia, Denmark

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

SOLTIVE™ Premium SuperPulsed Laser Fiber System

Device

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

Primary outcomes

  1. Stone free rate

    Time frame: 3 month

    Stone free rate as determined by standard of care imaging

Secondary outcomes

  1. Total laser energy time

    Time frame: During procedure

    Measured from first to last footswitch press in minutes

  2. Total procedure time

    Time frame: During procedure

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

  3. Accessory devices used

    Time frame: During procedure

    Types of accessory devices used during the procedure (ureteroscopy, PCNL or mini-PCNL) and the total time used during the procedure in minutes

  4. Adverse events

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

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

  5. Device deficiencies

    Time frame: During procedure

    Number of device deficiencies during the procedure

  6. Rate of treatment/interventions needed

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

    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

Sponsors and collaborators

Lead sponsor

Olympus Corporation of the Americas

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2020
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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