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A Preliminary study to measure intrarenal pressure and temperature of Zamenix P

A Preliminary study to measure intrarenal pressure and temperature searching for the most efficient and safe setting during laser stone fragmentation using of 'ZamenixTM P', robotic-assisted surgery system during Retrograde Intrarenal Surgery for stone removal

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010065
Enrollment
10
Registered
2024-12-19
Start date
2024-11-05
Completion date
Unknown
Last updated
2025-01-06

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 : Among those hospitalized for retrograde intrarenal stone surgery, those who agreed to participate in the clinical trial are eligible. When performing intrarenal stone removal surgery,

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have decided to undergo retrograde nephrolithotomy using a conventional flexible endoscopic approach and percutaneous nephrolithotomy due to stones that are difficult to pass naturally with non-surgical treatment, and who have signed and agreed to the clinical trial contents that they have become familiar with while hospitalized

Exclusion criteria

Exclusion criteria: Those who cannot stop taking anticoagulants and antiplatelet agents (except aspirin), those with bilateral stones that need to be removed at the same time, those who need to undergo other interventional surgeries in conjunction with retrograde nephrolithotomy (benign prostatic hyperplasia, ureteral junction and ureteral stricture, ureteral cancer, renal diverticulum, etc.), those with abnormalities in the anatomical structure of the ureter that make retrograde nephrolithotomy difficult, those who have received a kidney transplant, those diagnosed with chronic kidney disease, those with active urinary tract infection (UTI), those who are pregnant, those who have hypersensitivity to contrast media and have difficulty controlling it, those who have difficulty with local or general anesthesia, those who are currently participating in another clinical trial or have participated in another clinical trial within 30 days from the screening date, and others, those judged by the investigator to be inappropriate to participate in the clinical trial for ethical reasons or because it may affect the results of the clinical trial.

Design outcomes

Primary

MeasureTime frame
LS ratio(Laser : Stop ratio)

Secondary

MeasureTime frame
Surgical success rate, ureteral injury rate, surgical time, complication rate

Countries

Korea, Republic of

Contacts

Public ContactJiyun LEE

Seoul National University Hospital

jiyun@snuh.org+82-2-2072-0337

Outcome results

None listed

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