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Ultrasound for Kidney Stones Detection
N/A
Recruiting
Led By Thomas Chi, M.D.
Research Sponsored by University of California, San Francisco
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 4 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing how well ultrasound works to find kidney stone fragments, compared to the current standard (fluoroscopy).
Who is the study for?
This trial is for adults over 18 with diagnosed renal or ureteral stones scheduled for retrograde intrarenal surgery (RIRS). It's not suitable for patients having bilateral stone removal, those who refuse consent, pregnant women, kidney transplant recipients, individuals with ectopic kidneys, or if pain can't be managed in the ER.
What is being tested?
The study aims to compare the effectiveness of ultrasound versus traditional fluoroscopy in detecting remaining stone fragments during RIRS. The goal is to reduce radiation exposure and enhance care quality for patients and healthcare teams.
What are the potential side effects?
While the trial focuses on imaging techniques rather than medications, potential side effects may include discomfort from ultrasound application or complications related to incorrect detection of residual stones.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Diagnostic accuracy detecting residual fragments during retrograde intrarenal surgery
Secondary study objectives
Negative predictive value detecting residual fragments during retrograde intrarenal surgery
Operative time in minutes
Positive predictive value detecting residual fragments during retrograde intrarenal surgery
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: UltrasoundExperimental Treatment1 Intervention
Before completing retrograde intrarenal surgery, a complete endoscopic examination will be performed along with ultrasound by the same endourologist to determine the size of the largest residual fragment.
Group II: FluoroscopyActive Control1 Intervention
Standard of care, control Before completing retrograde intrarenal surgery, a complete endoscopic examination will be performed along with fluoroscopy by the same endourologist to determine the size of the largest residual fragment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~4090
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,004 Total Patients Enrolled
4 Trials studying Kidney Stones
3,759 Patients Enrolled for Kidney Stones
Thomas Chi, M.D.Principal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
100 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.You have had a kidney transplant.Your kidney is not located in its normal position.You have severe pain that cannot be relieved when you arrive at the Emergency Department.
Research Study Groups:
This trial has the following groups:- Group 1: Ultrasound
- Group 2: Fluoroscopy
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.
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