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Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
Sponsor: Lambda Surgical, Inc
Summary
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.
Key Details
Gender
MALE
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
10
Start Date
2026-11-01
Completion Date
2027-10
Last Updated
2026-11-03
Healthy Volunteers
Yes
Conditions
Locations (1)
PINE (Prostate Institution of New England)
Boston, Massachusetts, United States