Percutaneous Nephrolithotomy: A Registry and Database

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00159393
Recruitment Status : Recruiting
First Posted : September 12, 2005
Last Update Posted : June 28, 2018
Information provided by (Responsible Party):
James Lingeman, Indiana Kidney Stone Institute

Brief Summary:

Kidney stones vary in size from a tiny grain of sand to as large as filling the inside of the kidney. Treatment decisions depend on the size, location, and composition of the stone. Some kidney stones can be treated with lithotripsy (breaking up stones inside the body with shock waves created outside the body) or ureteroscopy (placing a small telescope up the urine channel to remove the stone). When stones are large in size or in the lower part of the kidney, a percutaneous (making a passage from the back into the kidney) procedure has been found to be the best method to remove the stones safely and efficiently. A passage is made into the back to allow a small telescope to see the stone and break it into fragments for removal. A small catheter is placed at the end of the procedure to allow the kidney to drain.

The purpose of this study is to record information about your surgery into a database so we can look at how patients who have had this procedure have done over time. We hope that reporting the outcomes of this surgery will be helpful to urologists and patients in the future. There may be certain factors that can be identified through this study as having better outcomes that may help make future surgeries safer.

Condition or disease Intervention/treatment
Nephrolithiasis Other: registry and database

Detailed Description:
Patients of IU Health Physicians Urology who have been scheduled to undergo percutaneous removal of one or more kidney stones will be asked to consent to be part of our registry and database for percutaneous procedures. The database contains information about the subjects surgery, such as stone size and location, number of access sites to remove the stone, length of stay in the hospital, secondary procedures, etc. This information is reviewed periodically to look for trends so that physicians may find ways to improve the percutaneous procedure. All information in the database is kept confidential. Data is collected at follow-up appointments at one month and one year to see if the subject is still stone free.

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Percutaneous Nephrolithotomy: A Registry and Database
Study Start Date : October 2003
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Intervention Details:
  • Other: registry and database
    data collection

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
urology clinic patients already scheduled for percutaneous removal of kidney stones


  • Patients of Methodist Urology in Indianapolis, IN
  • Male or female patients with upper urinary tract stone disease appropriate for percutaneous removal as determined by a Methodist Urology physician


  • Patients unable to give informed consent
  • Patients with active bleeding diatheses
  • Women who are pregnant or in whom pregnancy status cannot be confirmed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00159393

Contact: Kim Smoot 317-962-0869

United States, Indiana
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kim Smoot    317-962-0869   
Principal Investigator: James E Lingeman, MD         
Sponsors and Collaborators
Indiana Kidney Stone Institute
Principal Investigator: James E Lingeman, MD IU Health Physicians Urology

Additional Information:
Responsible Party: James Lingeman, James Lingeman, MD, Indiana Kidney Stone Institute Identifier: NCT00159393     History of Changes
Other Study ID Numbers: 03-096
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

Keywords provided by James Lingeman, Indiana Kidney Stone Institute:
Kidney stones
nephrolithotripsy percutaneous

Additional relevant MeSH terms:
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urinary Calculi
Pathological Conditions, Anatomical