Status:
COMPLETED
Robotic-assisted Percutaneous Access
Lead Sponsor:
NDR Medical Technology Pte Ltd
Collaborating Sponsors:
University of Malaya
Conditions:
Kidney Stone
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
This is a first-in-man (FIM) study to show feasibility and safety profile of the newly developed robotic device for percutaneous access in PCNL surgery. Patients with renal stone disease who had stand...
Detailed Description
All patients underwent preoperative investigations and imaging study (CT Urogram/Intravenous Pyelography) done prior to the operation as per standard operation preparation. Intraoperatively fluoroscop...
Eligibility Criteria
Inclusion
- Age between 21 to 75 years
- Diagnosed with kidney stone disease and planned for prone PCNL with indication for surgery as per standard of care
- Subject who understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
Exclusion
- Bleeding disorders
- Patient on anticoagulation/antiplatelets drugs
- Pyonephrosis
- Pregnant women
- Not able to have prone position for the procedure due to comorbidities
- Moderate to severe renal failure
- The patient's life expectancy is less than 12 months
- Poor compliance and patients unable to complete the study in accordance with the requirements.
Key Trial Info
Start Date :
August 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04435132
Start Date
August 7 2018
End Date
November 1 2018
Last Update
June 17 2020
Active Locations (1)
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1
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100