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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Willing and able to provide informed consent
2. ≥ 18 years of age
3. 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
Exclusion Criteria:
1. Concurrently participating in another competing clinical study
2. Contraindicated for endoscopic laser lithotripsy as determined by the Investigator
3. Subject is undergoing percutaneous nephrolithotomy (PCNL) or mini-PCNL
4. Subject presents will bladder stone(s) only
5. Subject presents with ureteral stricture disease or any anatomical abnormalities of the urinary system
6. Subject presents an active infection of the urinary tract (UTI) or sepsis of any origin
7. Subject is contraindicated for laser enucleation or ablation of the prostate as determined by the Investigator
8. Subject presents with prostate glands ≥ 200 grams
9. Subject is pregnant or breast feeding
Primary outcome measure(s)
Safety Measure — 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 — 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.
Trial sites (1)
Facility
City
Region
Status
University of Kansas Medical Center
Kansas City
Kansas
More Olympus Corporation of the Americas trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.