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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of procedure( about 90 minutes after start of procedure)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of procedure( about 90 minutes after start of procedure)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of procedure( about 90 minutes after start of procedure)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients that are stone free
Number of patients with symptom free survival as defined as lack of flank pain
Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.
+8 moreSecondary outcome measures
Number of patients that require pain medication (defined as discharge with an opioid prescription).
Number of patients with an infection rate which is defined as a positive culture within the study time period
Number of patients with nephrostomy access adequate for stone treatment
+2 moreTrial 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
910 Previous Clinical Trials
323,522 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the study presently accepting participants?
"The clinicaltrials.gov page suggests that this particular research project is not currently enrolling patients, having been first posted on January 1st 2023 and last updated on November 3rd 2022. Nevertheless, there are a plethora of other trials actively seeking applicants at the moment - 88 to be exact."
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