Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06394908 |
| Other study ID # |
MIUS.2022.001 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2023 |
| Est. completion date |
May 2027 |
Study information
| Verified date |
April 2024 |
| Source |
Marmara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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).
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.
