Robotic-assisted Percutaneous Access
- Conditions
- Kidney Stone
- Interventions
- Device: PCL under fluoroscopy with the aid of the robotic device
- Registration Number
- NCT04435132
- Lead Sponsor
- NDR Medical Technology Pte Ltd
- 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 standard indications for prone PCNL were included in the study. PCNL was conducted with percutaneous puncture with the aid of robotic device with the use of intra-operative fluoroscopy. 5 patients were recruited in this pilot study over a period of 3 months. Punctures were performed by the board-qualified urologist.
- 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 fluoroscopic imaging was done for the patients and the images were synchronized to the software. Robotic arm was placed on the site of surgery as for prone PCNL and diaphragm of the arm was centred over the site of desire calyx of entry. A needle was engaged into the centre of the diaphragm and using the software the need was aligned in the line of puncture automatically based on the fluoroscopic images. After the alignment was done the needle was advanced manually by the surgeon until the entry was confirmed by efflux of urine from the puncture needle. After the entry was confirmed a standard PCNL using 24 F or 30 F Balloon dilator was performed and stone cleared using Cyberwand/ Shockpulse etc. All the intraoperative and perioperative parameters as mentioned in the data collection form was measured. Results was analysed with the main focus on time of obtaining the puncture, accuracy of puncture, radiation exposure time till calyceal entry which was confirmed by free flow of urine and for any complications.
Patients aged between 21 to 75 years old who were diagnosed with kidney stone diseas and planned for prone PCNL with indication for surgery as per standard of care were recruited. They understood the purpose of testing and offered their voluntary and informed consent.
The robotic device i.e. ANT lesses the learning curve of percutaneous access as it reduces the need for surgeon's visualization of the calyceal system and the needle alignment. It also improved efficiency as there is less dependence on human skills during the procedure. As a whole, the FIM trial was a success. The performance of the ANT system during the trial was satisfactory. The robot alignment time is less than 30 seconds. Total puncture time was around 6 minutes and no AEs were reported.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PCNL with the aid of the robotic device PCL under fluoroscopy with the aid of the robotic device Patients will undergo prone PCNL under fluoroscopic guidance and with the aid of the robotic device.
- Primary Outcome Measures
Name Time Method Number of needle insertion attempts to obtain access During procedure Number of attempts before successfully reaching the calyx
Needle insertion time During procedure Time taken for PCNL procedure
Needle alignment time During procedure Time taken for needle alignment
Radiation dosage from placement of robot to efflux of urine During procedure A measure of the radiation exposed during the surgical procedure
Time to target During procedure Time taken for the needle to reach the calyx, from on the skin to successful needle targeting
Radiation dosage from placement of robot to successful needle target via image confirmation During procedure A measure of the radiation exposed during the surgical procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia