A Multicenter Study to Evaluate Whether Robotic Surgery for Kidney Stones Is Safer and More Effective Than Conventional Surgery

Comparison of the Safety and Efficacy of Robot-assisted Retrograde Intrarenal Surgery (RIRS) using Zamenix P and Percutaneous Nephrolithotomy (PCNL): A Multi-center, Propensity Score-Matched, Prospective-Retrospective, Superiority Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011653

Enrollment

Registered

2026-02-25

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-03-02

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 : The experimental group undergoes robotic-assisted retrograde intrarenal surgery (RIRS) using the “Zamenix P” system. Patients receive general or spinal anesthesia in the supine positi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 19 to less than 80 years 2. Patients with a cumulative stone length of 20–50 mm 3. Patients requiring retrograde intrarenal surgery (RIRS) or mini-percutaneous nephrolithotomy (mPCNL) due to stones that are unlikely to pass spontaneously with non-surgical treatment 4. Patients who voluntarily agree to participate in this study and provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with bilateral stones requiring simultaneous removal 2. Patients who require additional interventional surgery during RIRS† †: e.g., benign prostatic hyperplasia, ureteropelvic junction obstruction, ureteral stricture‡, ureteral carcinoma, bladder carcinoma, or other conditions deemed by the investigator to make RIRS difficult ‡: Ureteral dilation using ureteral access sheath due to anatomical structure (narrow ureter) rather than pathological stricture is allowed 3. Patients who have undergone kidney transplantation 4. Patients diagnosed with chronic kidney disease (GFR < 30 mL/min/1.73 m²) 5. Pregnant or breastfeeding women 6. Patients deemed inappropriate for study participation by the investigator

Design outcomes

Primary

Measure	Time frame
Postoperative complication rate	—

Secondary

Measure	Time frame
Stone-free rate;Operative time;Hospital stay;Blood loss	—

Countries

Korea, Republic of

Contacts

Public ContactEsther KIM

Seoul National University Hospital

giselle56@snu.ac.kr+82-2-2072-1491

Outcome results