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Mapping and Biopsy Study for Kidney Stones

N/A

Recruiting

Led By James Lingeman, MD

Research Sponsored by Indiana Kidney Stone Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Upper urinary tract endoscopic or PERC procedure for kidney stones removal

Be older than 18 years old

Must not have

Bleeding diathesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study Randall's plaques in patients with kidney stones to better understand what causes kidney stones.

Who is the study for?

This trial is for people in good health who need surgery to remove kidney stones or treat other urologic conditions at Methodist Urology in Indianapolis, IN. Participants must be able to complete all study requirements and sign a consent form. Those with bleeding disorders, poor health, or unable to follow post-surgery instructions cannot join.

What is being tested?

The study aims to better understand kidney stone causes by examining the papilla (kidney areas where stones attach) during surgery. It involves videotaping renal anatomy and taking papillary biopsies from patients undergoing stone removal procedures.

What are the potential side effects?

Since this trial involves standard surgical procedures for kidney stone removal, side effects may include typical surgical risks such as pain, infection risk at the biopsy site, bleeding, and potential complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a procedure to remove kidney stones using endoscopy or PERC.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: cohortExperimental Treatment1 Intervention

Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana University School of MedicineOTHER

192 Previous Clinical Trials

178,807 Total Patients Enrolled

University of ChicagoOTHER

1,062 Previous Clinical Trials

839,534 Total Patients Enrolled

Indiana Kidney Stone InstituteLead Sponsor

15 Previous Clinical Trials

5,585 Total Patients Enrolled

James Lingeman, MD4.629 ReviewsPrincipal Investigator - IU Health Physicians Urology

Indiana Kidney Stone Institute

1 Previous Clinical Trials

7 Total Patients Enrolled

1Patient Review

I was extremely disappointed with the care I received. I bled after surgery and was left alone to deal with the pain. I was in a bag for 15 days and never heard from the doctor. I was treated like a leper and now I'm suffering from frequent ITIs.