A Study to Compare ShockPulse-SE vs. Trilogy Lithotripters for Removal of Large Kidney 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: 17-006770
NCT ID: NCT03959683
Sponsor Protocol Number: 1803658961
About this study
The purpose of this study is to measure how well two different devices work to break up and remove kidney stones. We are comparing a newer device to an older one to see which one is faster at breaking up kidney stones. We hypothesize that the Trilogy device will increase the stone clearance rate by 25% compared to the Shockpulse-SE device.
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:
- ≥ 18 years of age.
- At least one renal stone > 1.5 cm in maximum diameter as measured on preoperative CT scan.
- Patient is scheduled to undergo a percutaneous nephrolithotomy procedure.
- Willing and able to provide informed consent
Exclusion Criteria:
- Pregnant.
- Active urinary tract infection.
- Prior shock wave lithotripsy within 3 months of study procedure.
- Multiple percutaneous access sites are anticipated.
- Unable or unwilling to provide informed consent.
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