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Moses 2.0 arm for Kidney Stones

N/A
Recruiting
Led By Amy Krambeck, MD
Research Sponsored by Northwestern University
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 day of procedure
Awards & highlights

Study Summary

This trial aims to compare the effectiveness of Moses 2.0 pulse modulation technology with the standard high powered Holmium Laser lithotripsy in treating kidney and ureteral stones. The study will

Who is the study for?
This trial is for individuals with kidney or ureteral stones measuring between 6mm and less than 20mm, who are undergoing a procedure called ureteroscopy. The study aims to include those who require stone removal using laser technology.Check my eligibility
What is being tested?
The study compares two methods of breaking down kidney stones: the Moses 2.0 pulse modulation technology versus the standard high-powered Holmium Laser without this feature. It will assess which method is more efficient in terms of operating time, laser usage, energy required, and success in eliminating stones.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, typical risks associated with laser lithotripsy may include discomfort during urination, bleeding around the stone fragments, infection risk from the procedure itself or passing stone fragments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Operative time
Stone Free Rate
Secondary outcome measures
Detection of postoperative strictures
Lasing time
Total laser energy (kJ)

Trial Design

2Treatment groups
Active Control
Group I: Moses 2.0 armActive Control1 Intervention
Ureteroscopy with high powered holmium laser lithotripsy with Moses 2.0 pulse modulation. Ureteral dusting settings: 0.2-0.3x60 Hz (not to exceed 20 W) Renal dusting settings: 0.2-0.3 J x 120 Hz (not to exceed 40 W)
Group II: Standard High-powered armActive Control1 Intervention
Ureteroscopy with high powered holmium laser lithotripsy without Moses 2.0 pulse modulation. Ureteral dusting settings: 0.2-0.3 x 60 Hz (not to exceed 20 W) Renal dusting settings: 0.2-0.5 J x 80 Hz standard (not to exceed 40 W)

Find a Location

Who is running the clinical trial?

Ohio State UniversityOTHER
830 Previous Clinical Trials
505,470 Total Patients Enrolled
2 Trials studying Kidney Stones
240 Patients Enrolled for Kidney Stones
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
916,937 Total Patients Enrolled
4 Trials studying Kidney Stones
334 Patients Enrolled for Kidney Stones
Amy Krambeck, MDPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
248 Total Patients Enrolled
1 Trials studying Kidney Stones
168 Patients Enrolled for Kidney Stones

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of individuals participating in this clinical investigation?

"Affirmative. Information available on clinicaltrials.gov indicates that this investigation is actively seeking eligible individuals. Originally shared on June 9th, 2023, the latest update was made on March 28th, 2024. The aim is to recruit a total of 150 participants from one designated site."

Answered by AI

Are individuals who have reached the age of 18 eligible to participate in this medical study?

"To be considered for this research, individuals aged between 18 to 90 are eligible. It is worth noting that there are separate trials available for those under 18 (5 trials) and over 65 (83 trials)."

Answered by AI

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"As per the information available on clinicaltrials.gov, this research is actively seeking volunteers. The study was first listed on June 9th, 2023 and its latest update was made on March 28th, 2024."

Answered by AI

May I inquire about the criteria for potential participation in this medical study?

"To qualify for participation in this research, individuals must have a history of nephrolithiasis and be between 18 and 90 years old. The study aims to recruit approximately 150 participants."

Answered by AI
~12 spots leftby Jun 2024