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Procedure
Robotic mini-Percutaneous Nephrolithotomy (PCNL) 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
STAR Trial 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.Check my eligibility
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.See study design
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.
STAR Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Kidney Stone Removal Procedure Completed
Secondary outcome measures
Number of Adverse Events
Number of Procedure Conversions to Conventional Treatment Methods due to study device-related safety event
Stone Free Rate (%)
STAR 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current number of participants being recruited for this medical research study?
"Indeed, the details on clinicaltrials.gov indicate that this current trial is actively seeking volunteers. Initially posted on January 18th, 2024, and last revised on March 19th, 2024, the study aims to enroll 60 participants at a single site."
Answered by AI
Are individuals currently able to apply and participate in this ongoing research study?
"Affirmative. Details on clinicaltrials.gov highlight the ongoing recruitment phase of this trial, which was originally uploaded on January 18th, 2024 and last modified on March 19th, 2024. The trial aims to enroll a total of 60 participants from one designated site."
Answered by AI
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