Modified SOLTIVE Study

N/ANot Yet RecruitingNCT07838077

Olympus Corporation of the Americas250 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Calculi, Renal Calculi, Urinary Benign Prostatic Hyperplasia

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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.

Central Contacts

Amanda Meyer

CONTACT

314-303-9510 amanda.meyer@olympus.com

Sharon Rabine

CONTACT

479-644-7840 sharon.rabine@olympus.com

Data from ClinicalTrials.gov

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