Evaluation of the efficacy and safety of robot-assisted retrograde intrarenal surgery with suction ureteral access sheath using Zamenix™ P

Evaluation of the efficacy and safety of robot-assisted retrograde intrarenal surgery with a suction ureteral access sheath using the Zamenix™ P: A single-center, comparative, exploratory clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011801

Enrollment

Registered

2026-04-01

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : In this study, patients undergoing robot-assisted retrograde intrarenal surgery (RIRS) using the Zamenix™ P flexible ureteroscopic robotic system will be evaluated according to the us

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 19 years or older and younger than 80 years 2. Patients with renal stones with a total maximal diameter =20 mm who are scheduled to undergo retrograde intrarenal surgery (RIRS) 3. Patients who voluntarily provide written informed consent after receiving sufficient explanation of the study 4. Patients scheduled to undergo surgery using a flexible ureteroscope

Exclusion criteria

Exclusion criteria: 1. Patients who do not provide informed consent to participate in the study 2. Patients with anatomical abnormalities of the urinary tract (e.g., horseshoe kidney, ectopic kidney, ureteral duplication, ureteropelvic junction obstruction) 3. Patients with uncontrolled severe systemic diseases such as severe cardiac or respiratory disease 4. Patients who cannot temporarily discontinue anticoagulant or antiplatelet therapy before or after surgery, or those with bleeding tendency (except prophylactic aspirin) 5. Patients with bilateral stones requiring simultaneous removal 6. Patients requiring additional interventional procedures during RIRS 7. Patients with a history of kidney transplantation 8. Patients with chronic kidney disease (GFR <45 mL/min/1.73m²) 9. Patients with active urinary tract infection (UTI) 10. Pregnant women 11. Patients with hypersensitivity to contrast media 12. Patients unable to undergo local or general anesthesia 13. Patients currently participating in another clinical trial or who participated in another trial within 30 days prior to screening 14. Patients judged by the investigator to be inappropriate for participation due to ethical or clinical reasons

Design outcomes

Primary

Measure	Time frame
Stone Free Rate (SFR)	—

Secondary

Measure	Time frame
Operative time;Retreatment rate;Postoperative hospital stay;Postoperative adverse event rate	—

Countries

Korea, Republic of

Contacts

Public Contactseola jung

Asan Medical Center

seolajung2@gmail.com@gmail.com+82-2-3010-3729

Outcome results