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Laser
Laser Lithotripsy with Moses Technology for Kidney Stones
N/A
Waitlist Available
Led By Nicole L Miller, MD
Research Sponsored by Vanderbilt University Medical Center
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 first 20 seconds of laser lithotripsy
Awards & highlights
Study Summary
This trial is testing whether a new laser technology can reduce operative time for treating kidney stones.
Who is the study for?
This trial is for adults with a single kidney stone or multiple stones that together measure 8-20 mm. Participants must be able to consent and fit the criteria for undergoing flexible ureteroscopy. Those with stones in the ureter, prior urinary tract surgeries, abdominal radiation therapy, neurogenic bladder conditions, pregnancy, or untreated UTIs cannot join.Check my eligibility
What is being tested?
The study compares two ways of breaking up kidney stones using lasers during ureteroscopy: one uses Moses Technology which may make laser energy delivery more efficient; the other does not use this technology. The goal is to see if Moses Technology can shorten surgery time.See study design
What are the potential side effects?
Potential side effects from holmium laser lithotripsy include discomfort during urination, bleeding within urine, possible infection risk increase due to the procedure itself and soreness where instruments are inserted.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ beginning to end of procedure time
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~beginning to end of procedure time
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Operative Time
Secondary outcome measures
Stone retropulsion
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Moses Laser LithotripsyExperimental Treatment1 Intervention
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique using Moses laser technology.
Group II: Standard Laser LithotripsyActive Control1 Intervention
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique (between 0.2-0.5 J and 40-80 Hz). The short pulse setting will be utilized for non-Moses settings.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Holmium laser lithotripsy with Moses Technology
2021
N/A
~180
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,021 Total Patients Enrolled
4 Trials studying Kidney Stones
269 Patients Enrolled for Kidney Stones
Naren Nimmagadda, MDStudy DirectorVanderbilt University Medical Center
Nicole L Miller, MDPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a single kidney stone that is between 8 and 20 millimeters in size, or multiple kidney stones that add up to a total size between 8 and 20 millimeters.You have stones in the ureter at the same time.You have had surgery on the same side of your body where the urinary tract is, or have a history of a narrow tube that carries urine from the kidney to the bladder on the same side of the body.You have had radiation treatment in your abdomen or pelvis before.You have a condition affecting your bladder or spinal cord.You have a urinary tract infection that has not been treated yet.You must be a suitable candidate for a specific type of surgery called flexible ureteroscopy, according to urology guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Laser Lithotripsy
- Group 2: Moses Laser Lithotripsy
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 size of this research project's participant pool?
"Affirmative. According to the clinicaltrials.gov page, this study opened on January 13th 2021 and is actively recruiting participants at 6 sites across the nation. The trial aims to enroll 300 patients in total."
Answered by AI
What is the geographical scope of this experiment?
"Presently, there are 6 trial centres providing the medication in question. These locations span from Cleveland to Phoenix and beyond, so it is best to select the closest facility for your convenience during enrollment."
Answered by AI
Are participants currently being accepted into this clinical trial?
"This investigation, originally posted on January 13th 2021 and recently updated on the 31st of January 2022 is actively searching for volunteers. This data can be found on clinicaltrials.gov"
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