~13 spots leftby Dec 2025

Mapping and Biopsy Study for Kidney Stones

Recruiting in Palo Alto (17 mi)
+1 other location
JL
Overseen byJames Lingeman, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Indiana Kidney Stone Institute
No Placebo Group

Trial Summary

What is the purpose of this trial?

Kidney stones are very common. They affect 3-5% of the population in the United States. Many people are hospitalized for the treatment of kidney stones and some may die. Better understanding of what causes kidney stones is useful in both the treatment and prevention of kidney stones. However, exactly what causes kidney stones is unknown. The most common type of kidney stones contains calcium, which sometimes is attached to a part of the kidney important in producing the final urine, called the papilla. The investigators have noticed that persons who form kidney stones seem to have more papilla with stones attached. They propose to study these areas of the papilla, called Randall's plaques (named after their discoverer), in patients undergoing surgery for kidney stones.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Mapping and Biopsy Study for Kidney Stones is an effective treatment?

The available research shows that renal biopsy, a key part of the Mapping and Biopsy Study for Kidney Stones, is highly valued for its role in diagnosing and managing kidney diseases. It is considered the best method for understanding kidney conditions, as it provides detailed information that other imaging techniques cannot. This makes it an essential tool for doctors to make informed decisions about patient care. While the studies focus on kidney disease in general, they highlight the importance and effectiveness of biopsy in improving patient outcomes.12345

What safety data exists for the kidney stone mapping and biopsy treatment?

The safety data for kidney biopsy, which is related to the treatment, indicates that it is a diagnostic tool with a low rate of complications. Studies have evaluated the safety of obtaining extra biopsy cores for biobanking and found that it does not significantly increase the risk of complications. Additionally, systematic reviews and registries have been established to track and analyze complications, primarily focusing on bleeding risks, to improve patient care and outcomes.26789

Is the treatment in the Mapping and Biopsy Study for Kidney Stones a promising treatment?

Yes, the treatment in the Mapping and Biopsy Study for Kidney Stones is promising because it uses a laparoscopic approach, which is less invasive than traditional open surgery. This method achieves the same goals with fewer complications, making it a valuable tool for diagnosing kidney issues.1011121314

Research Team

JL

James Lingeman, MD

Principal Investigator

IU Health Physicians Urology

Eligibility Criteria

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.

Inclusion Criteria

My health is good enough for surgery.
I have had a procedure to remove kidney stones using endoscopy or PERC.
I can complete all parts of the study.
See 2 more

Exclusion Criteria

I have a bleeding disorder.
Poor general medical health
Inability or unwillingness to comply with post-surgical follow-up

Treatment Details

Interventions

  • Videotape for Mapping of Renal Anatomy and Papillary Biopsy (Procedure)
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
IU Health Methodist HospitalIndianapolis, IN
IU Health North HospitalIndianapolis, IN
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Who Is Running the Clinical Trial?

Indiana Kidney Stone Institute

Lead Sponsor

Trials
16
Patients Recruited
6,200+

Indiana University School of Medicine

Collaborator

Trials
194
Patients Recruited
181,000+

University of Chicago

Collaborator

Trials
1086
Patients Recruited
844,000+

Findings from Research

The role of renal biopsy in small renal masses.Burruni, R., Lhermitte, B., Cerantola, Y., et al.[2020]
Protocol and establishment of a Queensland renal biopsy registry in Australia.Burke, JP., Aljishi, M., Francis, L., et al.[2021]
Renal biopsy: update.Whittier, WL., Korbet, SM.[2022]
The Native Kidney Biopsy: Update and Evidence for Best Practice.Hogan, JJ., Mocanu, M., Berns, JS.[2022]
A survey of current procedural practices of Australian and New Zealand nephrologists.Ritchie, AG., Saunders, J., Baer, R., et al.[2018]
Safety profile of paediatric percutaneous ultrasonography-guided renal biopsies.Skalova, S., Rejtar, P.[2010]
Bleeding complications of native kidney biopsy: a systematic review and meta-analysis.Corapi, KM., Chen, JL., Balk, EM., et al.[2022]
Safety of Obtaining an Extra Biobank Kidney Biopsy Core.Bermejo, S., García-Carro, C., Mast, R., et al.[2022]
Study of glomerulonephritis evolution in Castilla-La Mancha (GLOMANCHA) between 1994 and 2008.Conde Olasagasti, JL., Acevedo Ribó, M., Roca Muñoz, A., et al.[2017]
Laparoscopic renal exploration and biopsy.Squadrito, JF., Coletta, AV.[2019]
[Diagnostic value and safety of percutaneous kidney biopsy in experience of one clinical center].Adamczyk, P., Legaszewski, T., Banaszak, B., et al.[2008]
Renal biopsy: a review from experience.Hocken, AG.[2004]
The renal biopsy.Walker, PD.[2021]
Update on the Native Kidney Biopsy: Core Curriculum 2019.Luciano, RL., Moeckel, GW.[2019]

References

The role of renal biopsy in small renal masses. [2020]
Protocol and establishment of a Queensland renal biopsy registry in Australia. [2021]
Renal biopsy: update. [2022]
The Native Kidney Biopsy: Update and Evidence for Best Practice. [2022]
A survey of current procedural practices of Australian and New Zealand nephrologists. [2018]
Safety profile of paediatric percutaneous ultrasonography-guided renal biopsies. [2010]
Bleeding complications of native kidney biopsy: a systematic review and meta-analysis. [2022]
Safety of Obtaining an Extra Biobank Kidney Biopsy Core. [2022]
Study of glomerulonephritis evolution in Castilla-La Mancha (GLOMANCHA) between 1994 and 2008. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Laparoscopic renal exploration and biopsy. [2019]
[Diagnostic value and safety of percutaneous kidney biopsy in experience of one clinical center]. [2008]
Renal biopsy: a review from experience. [2004]
13.United Statespubmed.ncbi.nlm.nih.gov
The renal biopsy. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Update on the Native Kidney Biopsy: Core Curriculum 2019. [2019]