An observational study in Calculi, Renal, Calculi, Urinary and Benign Prostatic Hyperplasia, sponsored by Olympus Corporation of the Americas. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Olympus Corporation of the Americas (part of Olympus Corporation) · Observational
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.
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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 250 is above the median of 160 across 96 observational studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Olympus Corporation of the Americas is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients undergoing procedural laser treatment for urolithiasis, bladder, ureter, and kidney calculi, or benign prostatic hyperplasia.
Device: SOLTIVE Premium SuperPulsed Laser System
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.
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.
Time frame: 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.
Time frame: From procedural data collection to data entry, assessed up to 10 days.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2028, 18 months later.
Of 39 observational studies under Kidney Calculi, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Olympus Corporation of the Americas →