Real World Data Collection With an Investigational Device for Developing and Evaluating the Clinical Performance of Algorithms in Thulium Fiber Laser Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Safety Measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Safety Measure
时间窗: From enrollment to the resolution of the adverse event, assessed up to 30 days.
Incidence of procedure-related adverse events (AEs), serious adverse events (SAEs), and device deficiencies occurring during standard-of-care procedures performed using the Modified SOLTIVE Laser System, including assessment of relatedness to the investigational data-collection components.
Feasibility Measure
时间窗: From procedural data collection to data entry, assessed up to 10 days.
Proportion of enrolled subjects with a complete and evaluable procedural dataset, defined as successful collection of SOLTIVE laser procedural data, spectral log data, and endoscopic procedural video data.
次要结局
未报告次要终点