An interventional study of SOLTIVE™ Premium SuperPulsed Laser Fiber System in Kidney Stone and Ureteral Stone, sponsored by Olympus Corporation of the Americas. Completed at 7 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Olympus Corporation of the Americas (part of Olympus Corporation) · Not applicable, Interventional, and Treatment
The purpose of this study is to collect real-world evidence on the performance of the SOLTIVE™ Premium SuperPulsed Laser System for laser lithotripsy in ureteroscopy, percutaneous nephrolithotomy (PCNL) and mini PCNL for kidney and ureteral stones.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's enrollment of 450 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Olympus Corporation of the Americas is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who have a medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL
Device: SOLTIVE™ Premium SuperPulsed Laser Fiber System
SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only
Stone free rate
Stone free rate as determined by standard of care imaging
Time frame: 3 month
Total laser energy time
Measured from first to last footswitch press in minutes
Time frame: During procedure
Total procedure time
Measured from time of initial ureteroscope insertion to time of ureteroscope withdrawal in minutes
Time frame: During procedure
Accessory devices used
Types of accessory devices used during the procedure (ureteroscopy, PCNL or mini-PCNL) and the total time used during the procedure in minutes
Time frame: During procedure
Adverse events
AEs related to device or procedure and non-serious AEs related to device or procedure
Time frame: At procedure, immediate post-procedure, 1 month follow-up and 3 month follow-up
Device deficiencies
Number of device deficiencies during the procedure
Time frame: During procedure
Rate of treatment/interventions needed
Types of treatments and/or interventions needed post-procedure at the follow-up visits and the number of times treatments and/or interventions were performed
Time frame: At 1 month follow-up and 3 month follow-up
Plan to share: Yes — Subject data collected during the study after de-identification.
Supporting information: Study protocol, Clinical study report
Time frame: Immediately following publication
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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