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Robotic Device
Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) for Kidney Stones
N/A
Waitlist Available
Led By Jaime Landman, 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 30 days, post-operative (day 30)
Awards & highlights
Study Summary
This trial studies a robotic device for kidney stone removal. The data from this study will help improve the device and training for its use.
Eligible Conditions
- Kidney Stones
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days, post-operative (day 30)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days, post-operative (day 30)
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) Procedures Completed
Secondary outcome measures
Number of Adverse Events
Number of Procedures Converted to Conventional Methods (Ureteroscopy or Percutaneous Nephrolithotomy)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)Experimental Treatment1 Intervention
Participants with kidney stones will be enrolled for 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 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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Who is running the clinical trial?
Auris Health, Inc.Lead Sponsor
5 Previous Clinical Trials
810 Total Patients Enrolled
Jaime Landman, MDPrincipal InvestigatorUniversity of California, Irvine
7 Previous Clinical Trials
1,005 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is less than 40, which means you are not extremely overweight.
Research Study Groups:
This trial has the following groups:- Group 1: Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 sample size of this trial's participants?
"Affirmative. Clinical trials.gov reveals that this investigation is actively seeking participants, which was initially advertised on the 11th of January 2023 and last updated on April 18th 2023. It needs to recruit a total of twenty patients from one medical facility."
Answered by AI
Is it possible for participants to still join this investigation?
"As per information accessible on clinicaltrials.gov, this trial is still actively seeking suitable candidates to participate. The study was initially posted online on the 11th of January 2023 and had its most recent edit made on April 18th 2023."
Answered by AI
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