Modified SOLTIVE Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOlympus Corporation of the Americas
About this trial
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
This trial does not accept healthy volunteersQualifiers
Willing and able to provide informed consent
≥ 18 years of age
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
Disqualifiers
Concurrently participating in another competing clinical study
Contraindicated for endoscopic laser lithotripsy as determined by the Investigator
Subject is undergoing percutaneous nephrolithotomy (PCNL) or mini-PCNL
Subject presents will bladder stone(s) only
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
SOLTIVE Premium SuperPulsed Laser System
DeviceThe 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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Thulium Fiber Laser Procedure1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: