Clinical Trial: Surgery, Urology

Flexiva

Full Name

Flexiva Pulse Laser Fiber Post-Market Patient Registry

Description

This study is intended for individuals who are need of kidney stone removal (urinary calculus lithotripsy) or HoLEP procedures. Participation in this study would follow the standard of care treatment for these two conditions after use of the Flexiva™ Laser Fiber; 60 days post lithotripsy procedure and 180 days post HoLEP. The Flexiva™ Laser Fiber has been approved by the FDA.  

Purpose: The purpose of this study is to obtain post-market safety and efficacy data for Flexiva™ Pulse High Power Single-Use Laser Fibers during lithotripsy and soft tissue procedure of holmium laser enucleation of the prostate (HoLEP).

To Participate: Please contact the Network Office of Research and Innovation at 610-402-9543.

Eligibility

Inclusion Criteria

Eligibility: Inclusion Criteria-including but may not be limited to:

  1. For the lithotripsy individuals
    1. Undergoing treatment for urinary calculi
    2. Willing and able to return for standard of care follow up visits
  2. For the Benign Prostatic Hyperplasia (BPH) individuals
    1. Older than 40 years of age
    2. Diagnosed with benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
    3. Willing and able to return for standard of care follow up visits
Doctor(s) Running This Study