Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men

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 undergoing non-emergency cystoscopic procedures and, where specifically authorized under the approved research protocol, healthy adult male volunteers. Study participation involves use of the LambdaGuide System during cystoscopic visualization. For patients undergoing clinically indicated cystoscopy, the investigational measurements are performed alongside standard clinical care. LambdaGuide measurements will not be used to make diagnostic or therapeutic decisions, select treatment, or modify standard clinical care.

During the procedure, qualified clinicians will set up the LambdaGuide System, perform calibration using an approved calibration target, and attempt measurements of observable urinary anatomy. Potential measurement targets include anatomical openings or narrowing, urethral strictures, distances between anatomical landmarks, urinary tract lesions, stones, foreign bodies, and implant-related structures.

For each measurement attempt, the study will document the ability to obtain spatial information, select two valid measurement points, and display a point-to-point measurement. The primary performance endpoint is procedure-level clinical measurement feasibility, defined as obtaining at least one successful point-to-point measurement during an evaluable procedure.

Additional assessments include calibration success, camera deployment and image display, spatial capture success, measurement completion, calibration and measurement time, procedural interference, and clinician-reported usability. Optional observational comparisons with known-dimension references may be performed. These comparisons are descriptive and are not intended to establish measurement accuracy.

Safety will be evaluated through documentation of adverse events, including their severity, seriousness, and relationship to the investigational device or study procedures. Device deficiencies and malfunctions will also be recorded. Participants will undergo post-procedure safety assessment and follow-up approximately 30 days after the procedure, within a permitted window of ±5 days.

The study is intended to characterize the LambdaGuide System's ability to obtain measurements of visible genitourinary anatomy in a clinical environment and to collect performance, usability, and safety data to support further device evaluation.