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Procedure
Robotic Surgery for Kidney Stones (STAR Trial)
N/A
Recruiting
Led By Margaret A. Knoedler, MD
Research Sponsored by Auris Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to post-operative day 90
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to evaluate the success of a minimally invasive surgery called robotic mini-Percutaneous Nephrolithotomy (PCNL) using the MONARCH Platform in treating kidney stones.
Who is the study for?
This trial is for individuals with kidney stones. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed requirements on who can participate.
What is being tested?
The STAR Study is testing a procedure called robotic-assisted mini-PCNL using the MONARCH Platform in Urology. It aims to evaluate how well the procedure works, its ability to clear kidney stones post-operation, and its safety.
What are the potential side effects?
Potential side effects of robotic-assisted mini-PCNL may include discomfort at the site of surgery, bleeding, infection risk, or other complications related to minimally invasive surgical procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to post-operative day 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to post-operative day 90
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Kidney Stone Removal Procedure Completed
Secondary study objectives
Number of Adverse Events
Number of Procedure Conversions to Conventional Treatment Methods due to study device-related safety event
Stone Free Rate (%)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Robotic mini-Percutaneous Nephrolithotomy (PCNL)Experimental Treatment1 Intervention
Participants with kidney stones will be enrolled for a robotic-assisted mini-percutaneous nephrolithotomy procedure using the MONARCH Platform, Urology for removal of kidney stones. The MONARCH Platform, Urology enables electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible mini-PCNL suction catheter ("catheter") for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Robotic-assisted mini-PCNL
2023
N/A
~20
Find a Location
Who is running the clinical trial?
Auris Health, Inc.Lead Sponsor
5 Previous Clinical Trials
765 Total Patients Enrolled
Margaret A. Knoedler, MDPrincipal InvestigatorUniversity of Wisconsin, Madison