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NCT07838077
Modified SOLTIVE Study
Conditions: Calculi, Renal, Calculi, Urinary, Benign Prostatic Hyperplasia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 250
Sponsor: Olympus Corporation of the Americas
Location: University of Kansas Medical Center Kansas City Kansas
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 Criteria
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
Source: ClinicalTrials.gov (NCT07838077). StuddyBuddy aggregates publicly available trial information.