None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : On the day of surgery, subjects with an enrollment number will undergo RIRS as follows. An operator and assistant will perform RIRS and provide appropriate measures
Sponsors
EasyEndo Surgical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy all of the following inclusion criteria for enrollment. 1. The subjects must be adults between the age of 19 and 80 years old who require RIRS due to renal stones that are difficult to remove naturally through non-surgical treatment 2. They must have one or more renal stones with a maximum size between 5 mm and 30 mm 3. They must voluntarily decide to participate in this clinical trial and provide written consent 4. They must be willing to comply with the clinical trial protocol
Exclusion criteria
Exclusion criteria: The subjects who satisfy any of the following exclusion criteria may not participate in this clinical trial. 1. Those who cannot discontinue anti-coagulants or anti-platelet drugs, excluding aspirin 2. Those who have bilateral stones and who require simultaneous removal 3. Those who must undergo other interventional surgeries upon RIRS, such as for prostatic hypertrophy, ureteropelvic junction obstruction, ureteral stricture, ureteral carcinoma, calyceal diverticulum, and others 4. Those who would have difficulties to undergo RIRS due to abnormalities in the anatomical structure of the ureter 5. Those who underwent renal replacement therapy, through transplantation 6. Those who were diagnosed with chronic kidney disease 7. Those with active urinary tract infection (UTI) 8. Pregnant women 9. Those who are hypersensitive to contrast agents and whose responses are difficult to control 10. Those who have difficulties in undergoing local and general anesthesia 11. Those who are currently participating or have participated in another clinical trial within 30 days from the screening date 12. Those who may otherwise affect the results and are considered unfit for this clinical trial, upon the discretion of the investigator ? In these cases, the detailed reasons should be recorded in the case report form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate ;Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| Ureter injury rate ;Operation time ;Complication rate ;Operator fatigue, strain, and satisfaction;Conversion rate to classic RIRS | — |
Countries
Korea, Republic of
Contacts
Public ContactAYeon Hwang
Seoul National University Hospital
Outcome results
None listed