Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394908
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-01
First Post:
2024-04-18
Brief Title:
Registry of MIUS for Urolithiasis ReMIUS-U
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Registry of Minimally Invasive Urology Society for Urolithiasis Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
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:
ReMIUS-U
Brief Summary:
The purpose of this registry is to collect data on patients who have undergone minimally invasive treatments for urinary system stone disease including percutaneous nephrolithotomy PCNL shock wave lithotripsy SWL semi-rigid ureterorenoscopy URS and flexible ureterorenoscopy F-URS
Detailed Description:
In this project the Minimally Invasive Urology Association urolithiasis study group aimed to collect the data of adult and pediatric urinary system stone patients treated with PCNL SWL URS and F-URS in a non-randomized observational and prospective manner The registry was to be conducted multi-center in Turkey
In this project Excel files were created and shared via Google Drive with the responsible physicians at the centers to be included in the study Each parameter was prepared in an explanatory manner and can be readily filled out by physicians familiar with these methods The ability to examine and modify existing data will be restricted to the worker and the database administrator Patients identities will not be revealed in the registry
The collected data are summarized in three sections under the major headings below
1 Demographics and preoperative information Patient disease and treatment method demographic data such as age gender height weight previous diseases medications used location size and hardness of urinary tract stones the side of the stone and the methods used for diagnosis will be prospectively recorded for patients whose consent was obtained
2 Data during the operation The duration of the operation as well as the devices and methods utilized will be recorded
3 In the postoperative period post-treatment findings such as stone-free status and post-treatment complications will be documented
A separate application to the ethics committee will be submitted for each study on the subject that will be created in the future from the multi-center prospectively recorded data pool and on the subject that will be investigated
In this project Excel files were created and shared via Google Drive with the responsible physicians at the centers to be included in the study Each parameter was prepared in an explanatory manner and can be readily filled out by physicians familiar with these methods The ability to examine and modify existing data will be restricted to the worker and the database administrator Patients identities will not be revealed in the registry
The collected data are summarized in three sections under the major headings below
1 Demographics and preoperative information Patient disease and treatment method demographic data such as age gender height weight previous diseases medications used location size and hardness of urinary tract stones the side of the stone and the methods used for diagnosis will be prospectively recorded for patients whose consent was obtained
2 Data during the operation The duration of the operation as well as the devices and methods utilized will be recorded
3 In the postoperative period post-treatment findings such as stone-free status and post-treatment complications will be documented
A separate application to the ethics committee will be submitted for each study on the subject that will be created in the future from the multi-center prospectively recorded data pool and on the subject that will be investigated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None