Olympus Corporation of the Americas
This is a study to collect procedural data during the use of the SOLTIVE™ Premium SuperPulsed Laser System in the treatment of bladder, ureteral, and kidney stones and BPH to inform the development of software algorithms.
This prospective, observational study is being conducted to collect real-world procedural data and visual recordings during routine standard of care (SOC) urology procedures. These data will be used to support the research and development of future algorithmic software for the SOLTIVE™ Laser System with features designed to recognize anatomical structures and procedural contexts. The purpose of this study is limited to passive data acquisition and does not involve the clinical use of algorithmic decision support, modification of laser behavior, or changes to procedural technique or patient ma…
Inclusion Criteria: 1. Willing and able to provide informed consent 2. ≥ 18 years of age 3. The subject is presenting for the treatment of at least one of the following: a. Bladder, ureter, or kidney stones requiring endoscopic laser lithotripsy as determined by the Investigator b. BPH requiring surgical management with laser enucleation or vaporization of the prostate as determined by the Investigator c. Failed or unwilling to undergo medical (non-surgical) treatment of BPH Exclusion Criteria: 1. Concurrently participating in another competing clinical study 2. Contraindicated for endoscop…
The SOLTIVE™ Premium SuperPulsed Laser System is a thulium fiber laser (TFL) for lithotripsy and soft tissue ablation and enucleation procedures in the treatment of renal and urinary calculi and benign prostatic hyperplasia.
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