None listed
Conditions
Interventions
Medical Device : On the day of surgery, subjects with randomization numbers will undergo retrograde nephrolithotripsy surgery in the assigned treatment or control arm according to the following proced
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults between the ages of 19 and 80 who require retrograde intrarenal stone surgery for stones that are difficult to pass naturally with non-surgical treatments. 2. At least one stone greater than or equal to 5 mm and less than or equal to 30 mm in maximum length. 3. Voluntarily choose to participate in this clinical trial and provide written informed consent. 4. Willing to comply with the clinical trial protocol.
Exclusion criteria
Exclusion criteria: 1. Bilateral stones that need to be removed simultaneously 2. Requiring other interventional procedures to be performed at the time of retrograde intrarenal surgery (prostatic hyperplasia, renal ureteral stricture, ureteral carcinoma, renal diverticulum, parenchymal stone etc.). (*However, ureteral dilation to facilitate insertion of a ureteral access sheath due to an anatomically narrow ureter, rather than a pathological ureteral stricture, is permitted.) 3. Ureteral anatomy (congenital anomalies, etc.) considered difficult to perform retrograde intrarenal surgery 4. Renal transplant recipients 5. Those who have undergone ureteral reconstruction surgery (*However, enrollment may be permitted following prior discussion among the principal investigators of the participating institutions, including the study coordinating investigator, if transurethral insertion of a cystoscope, ureteroscope, ureteral access sheath, or other necessary instrument is considered feasible and the previous surgery is not expected to interfere with RIRS in either the intervention or control group.) 6. Diagnosed with chronic kidney disease(GFR < 45 mL/min/1.73m2) 7. Active urinary tract infection (active UTI) 8. Unable to discontinue anticoagulant and antiplatelet therapy before and after surgery, or who have a bleeding tendency that cannot be corrected (except for prophylactic aspirin therapy). 9. Difficulty receiving local or general anesthesia 10. Pregnant women 11. Women of childbearing potential who do not agree to use a medically acceptable method of birth control* during the study of an innovative medical technology. (*Hormonal Contraception, Intrauterine Device (IUD) or Intrauterine System (IUS), Tubal Ligation, Double Barrier Method (combination use of barriers such as male condom, female condom, cervical cap, diaphragm, sponge), Single Barrier Method with spermicide.) 12. Currently enrolled in another clinical trial, or enrolled in another clinical trial within 30 days of screening 13. Any other condition that, in the opinion of the investigator, is ethically or otherwise inappropriate for participation in an innovative medical technology study because it may affect the results of the innovative medical technology study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stone Free Rate(SFR, %);Adverse events (Intraoperative bleeding rate, ureteral injury rate, intraoperative renal tissue injury rate, and postoperative adverse event rate were evaluated separately) | — |
Secondary
| Measure | Time frame |
|---|---|
| Operative time(min): ?Anesthesia time ?Total operation time ?Flexible ureteroscopic time;Pain score(numeric rating scale);Analgesic dose;Quality of Life score ;Hospitalization period after surgery;Conversion rate to conventional RIRS(%);Operator's fatigue score;Stone ablation rate(mm3/min): Total stone volume divided by flexible ureteroscopic time | — |
Countries
Korea, Republic of
Contacts
Public ContactDeok Hyun Han
Samsung Medical Center
Outcome results
None listed