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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07838077). StuddyBuddy aggregates publicly available trial information.