Genitourinary AnatomyNCT07912385
Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
An observational study of Genitourinary Anatomy, run by Lambda Surgical, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Genitourinary Anatomy
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: No additional description beyond Eligibility Criteria. Subjects should be able to travel to a study site.
Who may be able to join
- Adult male subject (22 years of age or older).
- Subject who undergoes a non-emergency cystoscopic procedure, or a healthy volunteer.
- Able and willing to provide informed consent before study participation.
- Procedure is expected to provide visualization of observable urinary anatomy suitable for an attempted measurement.
- Investigator determines that study participation is appropriate and will not interfere with standard clinical care.
- Investigator determines, based on medical history and physical examination, that the subject is medically appropriate to undergo the study procedures.
Who cannot join
- Participation is expected to interfere with or materially delay standard clinical care.
- Known clinical condition or procedural circumstance that, in the investigator's judgment, makes study participation inappropriate.
- Inability to provide informed consent.
- Inability to use the required compatible cystoscope or approved study configuration.
- Known allergy or contraindication to the local anesthetic planned for the cystoscopic procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
PINE (Prostate Institution of New England)
Boston, Massachusetts, 02111
Alethia Chan, 857-800-2305, chanalethia@gmail.com
Louis Liou, MD, PhD
About this 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.
Read the detailed description
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.
- Conditions
- Genitourinary Anatomy
- Keywords
- Genitourinary Anatomy, Urologic Endoscopy, Cystoscopy, Anatomical Measurement, Point-to-Point Measurement, Optical Measurement, Endoscopic Imaging, Urethral Stricture
- Medical subject headings
- Urethral Stricture
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical measurement feasibility
Clinical measurement feasibility, assessed as a procedure-level pass/fail outcome. An evaluable procedure passes if at least one successful point-to-point measurement is obtained.
Measured: Procedure duration
Primary safety endpoint
Incidence, severity, seriousness, and relatedness of device-related, procedure-related, and other adverse events.
Measured: From procedure date to 30 days after (+/-5 days)
Secondary outcomes (9)
Calibration success
Calibration success
Measured: During Procedure
Camera deployment and expected image display
Camera deployment and expected image display
Measured: During Procedure
Spatial capture success
Spatial capture success
Measured: During Procedure
Valid point-selection success
Valid point-selection success
Measured: During Procedure
Successful measurement completion
Successful measurement completion
Measured: During Procedure
Calibration and measurement time
Calibration and measurement time (descriptive only)
Measured: During Procedure
Procedure interference
Procedure interference
Measured: During Procedure
User acceptance
User acceptance - based on Investigator Questionnaire
Measured: During Procedure
Observational comparative measurements (
Observational comparative measurements (descriptive only)
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary AnatomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lambda Surgical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis Liou, MD, PhD, Principal investigator, PINE - Prostate Institution of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912385
- Sponsor's protocol ID
- LG-GU-001
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
- ClinicalTrials.gov ID
- NCT07912385
- Acronym / sponsor ID
- LG-GU-001
- Conditions
- Genitourinary Anatomy
- Keywords
- Genitourinary Anatomy, Urologic Endoscopy, Cystoscopy, Anatomical Measurement, Point-to-Point Measurement, Optical Measurement, Endoscopic Imaging, Urethral Stricture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lambda Surgical, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- No additional description beyond Eligibility Criteria. Subjects should be able to travel to a study site.
Key inclusion criteria (6 listed)
- Adult male subject (22 years of age or older).
- Subject who undergoes a non-emergency cystoscopic procedure, or a healthy volunteer.
- Able and willing to provide informed consent before study participation.
- Procedure is expected to provide visualization of observable urinary anatomy suitable for an attempted measurement.
- Investigator determines that study participation is appropriate and will not interfere with standard clinical care.
Key exclusion criteria (5 listed)
- Participation is expected to interfere with or materially delay standard clinical care.
- Known clinical condition or procedural circumstance that, in the investigator's judgment, makes study participation inappropriate.
- Inability to provide informed consent.
- Inability to use the required compatible cystoscope or approved study configuration.
- Known allergy or contraindication to the local anesthetic planned for the cystoscopic procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical measurement feasibility
Time frame: Procedure duration
Clinical measurement feasibility, assessed as a procedure-level pass/fail outcome. An evaluable procedure passes if at least one successful point-to-point measurement is obtained.
Primary safety endpoint
Time frame: From procedure date to 30 days after (+/-5 days)
Incidence, severity, seriousness, and relatedness of device-related, procedure-related, and other adverse events.
9 secondary outcomes
Calibration success
Time frame: During Procedure
Camera deployment and expected image display
Time frame: During Procedure
Spatial capture success
Time frame: During Procedure
Valid point-selection success
Time frame: During Procedure
Successful measurement completion
Time frame: During Procedure
Calibration and measurement time
Time frame: During Procedure
Procedure interference
Time frame: During Procedure
User acceptance
Time frame: During Procedure
Observational comparative measurements (
Time frame: During Procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louis Liou, MD, PhD principal investigator
PINE - Prostate Institution of New England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genitourinary Anatomy, run by Lambda Surgical, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Lapp (678-231-0685, sarah@lambdasurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical measurement feasibility (time frame: Procedure duration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.