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

NCT04556201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2023-11-01

No results posted yet for this 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.

Conditions

  • Kidney Stone
  • Ureteral Stone

Interventions

DEVICE

SOLTIVE™ Premium SuperPulsed Laser Fiber System

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

Sponsors & Collaborators

  • Olympus Corporation of the Americas

    lead INDUSTRY

Principal Investigators

  • Ben Chew, MD · University of British Columbia

  • Olivier Traxer, MD · Tenon Hospital, Sorbonne University, Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-02-02
Completion
2023-05-30
FDA Device
Yes

Countries

  • United States
  • Denmark
  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04556201 on ClinicalTrials.gov