Lambda Surgical, Inc
This prospective clinical study will evaluate the feasibility, performance, and safety of the LambdaGuide System for obtaining point-to-point measurements of observable genitourinary anatomy during cystoscopic procedures in adult men. The system is intended to provide measurements of anatomical structures visible during cystoscopy without influencing clinical diagnosis or treatment decisions. The study will assess successful calibration, spatial capture, measurement point selection, and completion of point-to-point measurements. Device usability, procedural workflow effects, and adverse events will also be evaluated. Optional comparisons with known-dimension references may be performed for descriptive purposes. LambdaGuide measurements will not be used to guide or modify clinical care.
This is a prospective, observational clinical study designed to evaluate the feasibility, functional performance, usability, and safety of the LambdaGuide System during cystoscopic procedures in adult male participants aged 22 years and older. The LambdaGuide System is an investigational optical measurement system that integrates with a compatible cystoscope. It uses an optical camera module, calibration process, spatial capture, and software-based point selection to obtain point-to-point measurements of anatomical structures visible within the urinary tract. Participants may include men und…
Inclusion Criteria: 1. Adult male subject (22 years of age or older). 2. Subject who undergoes a non-emergency cystoscopic procedure, or a healthy volunteer. 3. Able and willing to provide informed consent before study participation. 4. Procedure is expected to provide visualization of observable urinary anatomy suitable for an attempted measurement. 5. Investigator determines that study participation is appropriate and will not interfere with standard clinical care. 6. Investigator determines, based on medical history and physical examination, that the subject is medically appropriate to und…
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