Viewing Study NCT00159393



Ignite Creation Date: 2024-05-05 @ 11:52 AM
Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00159393
Status: COMPLETED
Last Update Posted: 2021-02-11
First Post: 2005-09-08

Brief Title: Percutaneous Nephrolithotomy A Registry and Database
Sponsor: Indiana Kidney Stone Institute
Organization: Indiana Kidney Stone Institute

Study Overview

Official Title: Percutaneous Nephrolithotomy A Registry and Database
Status: COMPLETED
Status Verified Date: 2021-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None