Status:
UNKNOWN
A RCT to Evaluate the Efficacy and Safety of Automated Needle Targeting (ANT-X) System Compared to Traditional Free Hand Puncture for Renal Access in Percutaneous Nephrolithotomy (PCNL)
Lead Sponsor:
University of Malaya
Collaborating Sponsors:
NDR Medical Technology Pte Ltd
Conditions:
Kidney Stone
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Objectives: This study aims to determine if the device provides an advantage over traditional free hand puncture by comparing the number of attempts required to obtain access, time to achieve access, ...
Detailed Description
This is a single centre, participant randomized, open label study to evaluate the efficacy and safety of automated needle targeting (ANT-X) system compared to traditional free hand puncture for achiev...
Eligibility Criteria
Inclusion
- Subjects willing to sign informed consent form before initiation of any study specific procedures.
- Subjects diagnosed with kidney stones and planned for prone PCNL.
- Male/ non- pregnant female subjects between 18-75 years (both inclusive) of age at the time of informed consent.
- Subjects with renal stones of ≥1 cm or not managed by other stone treatments (e.g. shock wave lithotripsy, ureteroscopy).
- Serum creatinine of \< 1.2 mg/dl.
Exclusion
- Subjects with bleeding disorders.
- Recent infection of the kidney or urinary tract which leads to pus accumulation in the kidney, i.e., Pyonephrosis.
- Subjects not able to have prone positions for surgical procedure due to comorbid conditions.
- Renal stones \< 1 cm and can managed by another technique.
- Patients with moderate to severe renal failure.
- Patients with congenital urinary tract anomalies.
- Patients on anticoagulation or antiplatelet therapy.
- Evidence or history of any other disease that in the opinion of the investigator would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- Legal incapacity or other circumstances that render the subject unable to understand the nature, scope and possible consequences of the study.
- Clinically significant abnormal findings or condition (other than kidney stone), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05213702
Start Date
January 25 2022
End Date
December 31 2022
Last Update
January 28 2022
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