Recruiting

LambdaGuide System

Sponsor:

Lambda Surgical, Inc

Code:

NCT07912385

Conditions

Genitourinary Anatomy

Eligibility Criteria

Sex: Male

Age: 22+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Genitourinary Anatomy

Study ID

NCT07912385

Start date

Nov 1, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 22+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Clinical measurement feasibility [ Time Frame: Procedure duration ]
  • Primary safety endpoint [ Time Frame: From procedure date to 30 days after (+/-5 days) ]

Central Contacts and Locations

Central contacts

Locations

PINE (Prostate Institution of New England)

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Principal Investigator:

Louis Liou, MD, PhD

More Information

Sponsor

Lambda Surgical, Inc

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

  • Genitourinary Anatomy
  • Urologic Endoscopy
  • Cystoscopy
  • Anatomical Measurement
  • Point-to-Point Measurement
  • Optical Measurement
  • Endoscopic Imaging
  • Urethral Stricture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Lambda Surgical, Inc on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.