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Retrograde vs Antegrade Nephrostomy for Kidney Stones
N/A
Waitlist Available
Led By Nadeem N Dhanani, MD,MPH
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Renal pelvis and proximal ureteral stones >10 mm confirmed with non-contrast computed tomography
Must not have
Anatomical abnormal kidney, including Horseshoe and Ectopic
Suspected pyelonephritis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two different ways to do a nephrostomy on patients with urolithiasis to see which is better, and what characteristics predict success for each approach.
Who is the study for?
This trial is for individuals with large kidney stones (>10 mm) located in the renal pelvis or upper ureter, as confirmed by CT scans. It's not suitable for those who've had previous stone removal from the same kidney, have a current kidney infection, are pregnant, or have an abnormally shaped kidney like Horseshoe or Ectopic kidneys.
What is being tested?
The study compares two techniques of creating a channel to reach and remove kidney stones: one where access is made going backwards (retrograde) into the urinary system versus another where access is made going forwards (antegrade). The goal is to see which method leads to better outcomes.
What are the potential side effects?
Potential side effects may include discomfort at the site of entry, bleeding, possible injury to surrounding tissues or organs during the procedure, and risks associated with anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have kidney stones larger than 10 mm in my renal pelvis or ureter.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an abnormal kidney shape or position.
Select...
I am suspected to have a kidney infection.
Select...
I have kidney stones in the middle or lower part of my ureter.
Select...
I have had a kidney stone removal surgery in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours after procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients that are stone free
Secondary study objectives
Number of patients with normal laboratory values
Awards & 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: Treatment (retrograde nephrostomy)Experimental Treatment1 Intervention
Group II: Control Group ( antegrade nephrostomy)Active Control1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,807 Total Patients Enrolled
Nadeem N Dhanani, MD,MPHPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an abnormal kidney shape or position.I am suspected to have a kidney infection.I have kidney stones larger than 10 mm in my renal pelvis or ureter.I have kidney stones in the middle or lower part of my ureter.I have had a kidney stone removal surgery in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (retrograde nephrostomy)
- Group 2: Control Group ( antegrade nephrostomy)
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.