Home › NCT07912385

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

Who can join

Ages 22 and older · Men · Healthy volunteers welcome

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 undergo the study procedures.

Exclusion Criteria:

1. Participation is expected to interfere with or materially delay standard clinical care.
2. Known clinical condition or procedural circumstance that, in the investigator's judgment, makes study participation inappropriate.
3. Inability to provide informed consent.
4. Inability to use the required compatible cystoscope or approved study configuration.
5. Known allergy or contraindication to the local anesthetic planned for the cystoscopic procedure.

About the study

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.

Sponsor: Lambda Surgical, Inc · Participants: 10 · Started: Nov 1, 2026

Contact the study team

• Sarah Lapp · Phone: 678-231-0685

Official record on ClinicalTrials.gov — NCT07912385

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.