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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to post-operative day 90 for reporting.

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

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