Modified SOLTIVE Study

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 management. Patients undergoing SOC lithotripsy for bladder, ureter, and kidney calculi (colloquially called "stones") and patients undergoing soft tissue procedures for benign prostatic hyperplasia (BPH) will be considered for inclusion in the study.

Inclusion criteria

• Willing and able to provide informed consent
• ≥ 18 years of age
• 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

• Concurrently participating in another competing clinical study
• Contraindicated for endoscopic laser lithotripsy as determined by the Investigator
• Subject is undergoing percutaneous nephrolithotomy (PCNL) or mini-PCNL
• Subject presents will bladder stone(s) only
• Subject presents with ureteral stricture disease or any anatomical abnormalities of the urinary system
• Subject presents an active infection of the urinary tract (UTI) or sepsis of any origin
• Subject is contraindicated for laser enucleation or ablation of the prostate as determined by the Investigator
• Subject presents with prostate glands ≥ 200 grams
• Subject is pregnant or breast feeding