Calculi, RenalNCT07838077
Modified SOLTIVE Study
An observational study of Calculi, Renal and Calculi, Urinary, run by Olympus Corporation of the Americas at 1 site in United States.
Trial summary
This is a study to collect procedural data during the use of the SOLTIVE™ Premium SuperPulsed Laser System in the treatment of bladder, ureteral, and kidney stones and BPH to inform the development of software algorithms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calculi, Renal, Calculi, Urinary, Benign Prostatic Hyperplasia
- What is being tested?
- SOLTIVE Premium SuperPulsed Laser System
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to May 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adult patients diagnosed with urolithiasis, bladder, ureter, and kidney calculi, or benign prostatic hyperplasia who are scheduled to undergo laser treatment.
Who may be able to join
- Willing and able to provide informed consent
- ≥ 18 years of age
- The subject is presenting for the treatment of at least one of the following: a. Bladder, ureter, or kidney stones requiring endoscopic laser lithotripsy as determined by the Investigator b. BPH requiring surgical management with laser enucleation or vaporization of the prostate as determined by the Investigator c. Failed or unwilling to undergo medical (non-surgical) treatment of BPH
Who cannot join
- Concurrently participating in another competing clinical study
- Contraindicated for endoscopic laser lithotripsy as determined by the Investigator
- Subject is undergoing percutaneous nephrolithotomy (PCNL) or mini-PCNL
- Subject presents will bladder stone(s) only
- Subject presents with ureteral stricture disease or any anatomical abnormalities of the urinary system
- Subject presents an active infection of the urinary tract (UTI) or sepsis of any origin
Show all 9Show fewer
- Subject is contraindicated for laser enucleation or ablation of the prostate as determined by the Investigator
- Subject presents with prostate glands ≥ 200 grams
- Subject is pregnant or breast feeding
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
University of Kansas Medical Center
Kansas City, Kansas, 66160
Jane Ledesma, 913-588-8721, jledesma2@kumc.edu
About this study
Official title: Real World Data Collection With an Investigational Device for Developing and Evaluating the Clinical Performance of Algorithms in Thulium Fiber Laser Procedures
This is a study to collect procedural data during the use of the SOLTIVE™ Premium SuperPulsed Laser System in the treatment of bladder, ureteral, and kidney stones and BPH to inform the development of software algorithms.
Read the detailed description
This prospective, observational study is being conducted to collect real-world procedural data and visual recordings during routine standard of care (SOC) urology procedures. These data will be used to support the research and development of future algorithmic software for the SOLTIVE™ Laser System with features designed to recognize anatomical structures and procedural contexts.
The purpose of this study is limited to passive data acquisition and does not involve the clinical use of algorithmic decision support, modification of laser behavior, or changes to procedural technique or patient management. Patients undergoing SOC lithotripsy for bladder, ureter, and kidney calculi (colloquially called "stones") and patients undergoing soft tissue procedures for benign prostatic hyperplasia (BPH) will be considered for inclusion in the study.
- Being tested
- SOLTIVE Premium SuperPulsed Laser System
- Keywords
- Renal Calculi, Urinary Calculi, Benign Prostatic Hyperplasia, SOLTIVE SuperPulsed Laser System
- Medical subject headings
- Kidney Calculi, Urinary Calculi, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOLTIVE Premium SuperPulsed Laser SystemDevice
The SOLTIVE™ Premium SuperPulsed Laser System is a thulium fiber laser (TFL) for lithotripsy and soft tissue ablation and enucleation procedures in the treatment of renal and urinary calculi and benign prostatic hyperplasia.
| Study group | Role | What they receive |
|---|---|---|
| Thulium Fiber Laser Procedure | Adult patients undergoing procedural laser treatment for urolithiasis, bladder, ureter, and kidney calculi, or benign prostatic hyperplasia. Receives: Device: SOLTIVE Premium SuperPulsed Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Measure
Incidence of procedure-related adverse events (AEs), serious adverse events (SAEs), and device deficiencies occurring during standard-of-care procedures performed using the Modified SOLTIVE Laser System, including assessment of relatedness to the investigational data-collection components.
Measured: From enrollment to the resolution of the adverse event, assessed up to 30 days.
Feasibility Measure
Proportion of enrolled subjects with a complete and evaluable procedural dataset, defined as successful collection of SOLTIVE laser procedural data, spectral log data, and endoscopic procedural video data.
Measured: From procedural data collection to data entry, assessed up to 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calculi, RenalStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838077
- Sponsor's protocol ID
- 2024-URO-01
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Data Collection With an Investigational Device for Developing and Evaluating the Clinical Performance of Algorithms in Thulium Fiber Laser Procedures
- ClinicalTrials.gov ID
- NCT07838077
- Acronym / sponsor ID
- 2024-URO-01
- Keywords
- Renal Calculi, Urinary Calculi, Benign Prostatic Hyperplasia, SOLTIVE SuperPulsed Laser System
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 24 Sep 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 is a study to collect procedural data during the use of the SOLTIVE™ Premium SuperPulsed Laser System in the treatment of bladder, ureteral, and kidney stones and BPH to inform the development of software algorithms.
Detailed description
This prospective, observational study is being conducted to collect real-world procedural data and visual recordings during routine standard of care (SOC) urology procedures. These data will be used to support the research and development of future algorithmic software for the SOLTIVE™ Laser System with features designed to recognize anatomical structures and procedural contexts.
The purpose of this study is limited to passive data acquisition and does not involve the clinical use of algorithmic decision support, modification of laser behavior, or changes to procedural technique or patient management. Patients undergoing SOC lithotripsy for bladder, ureter, and kidney calculi (colloquially called "stones") and patients undergoing soft tissue procedures for benign prostatic hyperplasia (BPH) will be considered for inclusion in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thulium Fiber Laser Procedure | – | Device: SOLTIVE Premium SuperPulsed Laser SystemAdult patients undergoing procedural laser treatment for urolithiasis, bladder, ureter, and kidney calculi, or benign prostatic hyperplasia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult patients diagnosed with urolithiasis, bladder, ureter, and kidney calculi, or benign prostatic hyperplasia who are scheduled to undergo laser treatment.
Key inclusion criteria (3 listed)
- Willing and able to provide informed consent
- ≥ 18 years of age
- The subject is presenting for the treatment of at least one of the following: a. Bladder, ureter, or kidney stones requiring endoscopic laser lithotripsy as determined by the Investigator b. BPH requiring surgical management with laser enucleation or vaporization of the prostate as determined by the Investigator c. Failed or unwilling to undergo medical (non-surgical) treatment of BPH
Key exclusion criteria (9 listed)
- Concurrently participating in another competing clinical study
- Contraindicated for endoscopic laser lithotripsy as determined by the Investigator
- Subject is undergoing percutaneous nephrolithotomy (PCNL) or mini-PCNL
- Subject presents will bladder stone(s) only
- Subject presents with ureteral stricture disease or any anatomical abnormalities of the urinary system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOLTIVE Premium SuperPulsed Laser SystemThe SOLTIVE™ Premium SuperPulsed Laser System is a thulium fiber laser (TFL) for lithotripsy and soft tissue ablation and enucleation procedures in the treatment of renal and urinary calculi and benign prostatic hyperplasia. | Device | Thulium Fiber Laser Procedure |
Primary outcome
Safety Measure
Time frame: From enrollment to the resolution of the adverse event, assessed up to 30 days.
Incidence of procedure-related adverse events (AEs), serious adverse events (SAEs), and device deficiencies occurring during standard-of-care procedures performed using the Modified SOLTIVE Laser System, including assessment of relatedness to the investigational data-collection components.
Feasibility Measure
Time frame: From procedural data collection to data entry, assessed up to 10 days.
Proportion of enrolled subjects with a complete and evaluable procedural dataset, defined as successful collection of SOLTIVE laser procedural data, spectral log data, and endoscopic procedural video data.
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Calculi, Renal and Calculi, Urinary, run by Olympus Corporation of the Americas 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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 5 Oct 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 Amanda Meyer (314-303-9510, amanda.meyer@olympus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Measure (time frame: From enrollment to the resolution of the adverse event, assessed up to 30 days.). 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 5 Oct 2026.