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RECRUITING
NCT07912385

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

Sponsor: Lambda Surgical, Inc

View on ClinicalTrials.gov

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

Locations (1)

PINE (Prostate Institution of New England)

Boston, Massachusetts, United States