Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT04435132
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.
Study:
NCT04435132
Study Brief:
Protocol Section:
NCT04435132