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Not Applicable
Stent Placement After Ureteroscopy for Kidney Stones
N/A
Recruiting
Led By Ryan Hsi, 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
Nonobstructing renal stone 1.5cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing ureteroscopy
Be older than 18 years old
Must not have
Solitary kidney or eGFR <60 mL/min (CKD stage 3 or greater)
Age < 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline 5-10 days after ureteroscopy
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether or not a stent inserted after a surgery to remove kidney stones leads to fewer complications than not having a stent.
Who is the study for?
This trial is for adults with nonobstructing kidney stones smaller than 1.5cm in total diameter who are undergoing ureteroscopy. It's not for those under 18, pregnant, planning multiple surgeries, or with certain kidney conditions like a solitary kidney or reduced function (eGFR <60 mL/min).
What is being tested?
The study aims to see if there's a difference in complications when patients receive a stent after ureteroscopy for kidney stones versus not receiving one at all.
What are the potential side effects?
Potential side effects may include discomfort from the stent, urinary symptoms like frequent urination or urgency, blood in urine, and possibly increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a kidney stone smaller than 1.5cm and am getting a ureteroscopy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have one kidney or my kidney function is reduced.
Select...
I am under 18 years old.
Select...
I have a kidney stone in my ureter.
Select...
I have an unusual kidney shape or had surgery on my urinary tract.
Select...
I am scheduled for a procedure to examine both of my ureters.
Select...
I have swelling of a kidney due to urine buildup before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5-10 days after ureteroscopy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-10 days after ureteroscopy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total number of complications
Secondary study objectives
% return to work
Cumulative opiate morphine equivalent dosing (MED)
Number of participants with abnormal imaging findings
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Ureteral stent groupActive Control1 Intervention
A ureteral stent will be placed after ureteroscopy.
Group II: No ureteral stent groupActive Control1 Intervention
A ureteral stent will not be placed after ureteroscopy.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesOTHER
1,569 Previous Clinical Trials
10,314,089 Total Patients Enrolled
1 Trials studying Kidney Stones
43 Patients Enrolled for Kidney Stones
Brigham and Women's HospitalOTHER
1,670 Previous Clinical Trials
11,878,066 Total Patients Enrolled
2 Trials studying Kidney Stones
43 Patients Enrolled for Kidney Stones
Penn State HealthUNKNOWN
1 Previous Clinical Trials
1,032 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
908 Previous Clinical Trials
934,387 Total Patients Enrolled
6 Trials studying Kidney Stones
520 Patients Enrolled for Kidney Stones
Université de MontréalOTHER
221 Previous Clinical Trials
103,995 Total Patients Enrolled
2 Trials studying Kidney Stones
3,449 Patients Enrolled for Kidney Stones
University of California, DavisOTHER
946 Previous Clinical Trials
4,755,930 Total Patients Enrolled
3 Trials studying Kidney Stones
3,612 Patients Enrolled for Kidney Stones
University of California, San DiegoOTHER
1,189 Previous Clinical Trials
1,587,541 Total Patients Enrolled
10 Trials studying Kidney Stones
4,228 Patients Enrolled for Kidney Stones
Indiana UniversityOTHER
1,045 Previous Clinical Trials
1,316,684 Total Patients Enrolled
4 Trials studying Kidney Stones
173 Patients Enrolled for Kidney Stones
Ryan Hsi, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Hospital
Loma Linda University School Of Medicine (Medical School)
2 Previous Clinical Trials
136 Total Patients Enrolled
2 Trials studying Kidney Stones
136 Patients Enrolled for Kidney Stones
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have one kidney or my kidney function is reduced.I am under 18 years old.I have a kidney stone smaller than 1.5cm and am getting a ureteroscopy.I have a kidney stone in my ureter.I have an unusual kidney shape or had surgery on my urinary tract.I am scheduled for a procedure to examine both of my ureters.You currently have a tube in your kidney for draining urine.Whether or not the participant is pregnant.I have swelling of a kidney due to urine buildup before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Ureteral stent group
- Group 2: No ureteral stent group
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.