Abstract

To test in-vitro and in-vivo the Flexor® Vue™ deflecting endoscopic system (FVDES) as a new technology able to improve the removal of residual intrarenal fragments.This is an observational prospective "proof of concept" study performed in patients with renal calculi treated with flexible ureteroscopy and Ho:YAG laser lithotripsy (f-URS) in Humanitas Research Hospital (Rozzano, Italy). We assessed feasibility, efficacy and safety of FVDES as an in-vivo tool for removing residual fragments after f-URS. The stone-free rate (SFR) at 30days post-operatively was evaluated using CT. An in-vitro model was developed to evaluate the FVDES when used for this purpose.Eleven patients (M/F ratio: 7/4, mean age 63.5 ± 8.3) were treated. The stones were located in the lower calyces and the renal pelvis in 3 and 8 patients, respectively. Mean stone size was 18 ± 3.2mm. The procedure with FVDES was feasible and effective in all the patients. Mean operative time was 82 ± 13.7min and median hospitalization was of 1.5days. The SFR after 90days was 81% (9/11). We reported no relevant complications (Clavien-Dindo > 2); one patient had fever and was treated with antibiotics. The experimental in-vitro model demonstrated the efficacy of FVDES, allowing the removal of about 90% of fragments.Our study showed that FVDES is effective when used as a tool for retrieval of residual fragments at the end of f-URS. This technology could ensure a complete cleaning of the intrarenal collecting system and represent a safe alternative to basketing.

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