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Evaluation the efficacy and safety of the roboticflexible ureteroscopy system ‘Zamenix™ P’ compare toretrograde intrarenal surgery (RIRS)

Evaluation the efficacy and safety of the roboticflexible ureteroscopy system ‘Zamenix™ P’ compare toretrograde intrarenal surgery (RIRS): A single -center,comparative, open -label, exploratory clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010109
Enrollment
40
Registered
2025-01-03
Start date
2025-05-27
Completion date
Unknown
Last updated
2025-07-21

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 prospectively collected data from 20 patients who underwent robot-assisted retrograde intrarenal stone surgery using the automated system robotic surgical machi

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: * Test group 1. Study subjects aged 19 to 80 years 2. Patients with a total maximal diameter of renal stones = 20 mm and who are scheduled for retrograde intrarenal surgery (RIRS). 3. Those who have given written consent to the clinical trial contents that they are familiar with 4. Those scheduled to undergo surgery using a flexible ureteroscope Lithovue (Boston Scientific) *Control group 1. Patients aged 19 to 80 years 2. Patients with a total maximal diameter of renal stones = 20 mm and who are scheduled for retrograde intrarenal surgery (RIRS). 3. Patients who underwent surgery for kidney stones between January 2017 and June 2024 using a flexible ureteroscope Lithovue (Boston Scientific) 4. Patients who have been followed up for 6 months after surgery

Exclusion criteria

Exclusion criteria: * test group 1 A person who has not consented to a clinical trial 2 Patients with anatomical abnormalities in the urinary system (such as horseshoe or optoptic kidney, ureteral duplication, ureteropelvic motion construction, etc.) 3 Patients with uncontrolled medical conditions (such as severe cardiac disease [ASA class 3 or 4], severe respiratory disease, etc.) 4 Those who are unable to discontinue anticoagulant therapy and antiplatelet medication (except aspirin) 5 If you have bilateral stones and need to remove them at the same time 6 In retrograde endocrine stone surgery, other interventional surgeries must also be performed (prostate hypertrophy, renal ureteral transition and ureteral stenosis, ureteral carcinoma, kidney diverticulum, etc.) 7 A person who has received a kidney transplant 8 A person diagnosed with chronic kidney disease 9 Active Urinary Fact Infection (UTI) 10 Pregnant 11 A person who overreacts to a contrast medium and has difficulty controlling it 12 When both local and general anesthesia are difficult 13 A person who is currently participating in another clinical trial or who has participated in another clinical trial within 30 days as of the screening date 14 In addition, when the tester determines that participation in the clinical trial is inappropriate because it may affect the outcome of the clinical trial ethically or as a result of the clinical trial * a control group 1 A patient who has undergone bilateral kidney stones 2 Patients with other interventional surgeries (prostate hypertrophy, renal ureteral transition and ureteral stenosis, ureteral carcinoma, kidney diverticulum, etc.)

Design outcomes

Primary

MeasureTime frame
stone removal rate

Secondary

MeasureTime frame
prognostic factors affecting surgical performance

Countries

Korea, Republic of

Contacts

Public Contactseola Jung

Asan Medical Center

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

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026