The Performance of the SOLTIVE™ Laser System for Laser Lithotripsy in Kidney or Ureteral Stones
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 21-008267
NCT ID: NCT04556201
Sponsor Protocol Number: 2020-URO-01
About this study
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, PCNL or mini PCNL for kidney and ureteral stones.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Individuals ≥ 18 years of age.
- Medical indication for ureteroscopy, PCNL or mini PCNL.
- Willing and able to provide informed consen.
- Female and of childbearing age with a negative pregnancy test.
Exclusion Criteria:
- Contraindicated for ureteroscopy, PCNL or mini PCNL as determined by the physician.
- Inability to tolerate anesthesia for any reason.
- Unable or unwilling to provide informed consent.
- Concurrently participating in another competing clinical study.
- Known ureteral stricture.
- Unwilling or unable to return for follow-up.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Mitchell Humphreys, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available