First-In-Human Clinical Experience with the Zamenix P Robotic Flexible Ureteroscopy Platform: A Single-Center Case Series
Jong Hoon Lee, Chung Un Lee, Jiwoong Yu, Sung Si Hyun, Jaeik Song, Deok Hyun HanIntroduction:
Conventional flexible ureteroscopy (fURS) remains technically demanding, requiring substantial endourologic expertise and optimal ergonomics. We report our initial clinical experience evaluating the feasibility and safety of Zamenix P, a novel robot-assisted platform for renal calculus management.
Methods:
Medical records were reviewed for patients who underwent fURS with Zamenix P during June 1 to June 30, 2024. A single-use flexible ureteroscope (LithoVue) was used with a robotic platform. After docking, the procedure was conducted from a remote console with bedside assistance. Stone disintegration was performed with a Holmium:YAG laser system, as in conventional retrograde intrarenal surgery, and fragments were extracted with a robot-controlled nitinol basket. Respiratory motion compensation, automated driving assistance, and stone size estimation were used. Stone-free status (residual fragments ≤2 mm) was assessed by noncontrast computed tomography 1 month postoperatively.
Results:
Nine patients underwent 10 robotic fURS procedures. The median stone diameter was 18.0 mm; stones were located in the renal pelvis (40.0%), lower calyx (30.0%), upper calyx (10.0%), or multiple locations (20.0%). Median robot docking time was 4.0 (3.0–5.0) min. Median total operative time and stone removal time were 144.0 (93.0–160.0) and 90.0 (73.0–132.0) min, respectively. Ureteral balloon dilation was required in 20.0% of cases. Intraoperative ureteral injury occurred in 50.0% of patients (grade 1, 20.0%; grade 2, 20.0%; and grade 3, 10.0%). The 1-month stone-free rate was 80.0%. Median hospitalization was 3.0 (2.0–3.0) days, with one postoperative perirenal hematoma and one ipsilateral pleural effusion case.
Conclusion:
Robotic fURS using Zamenix P appeared technically feasible in this cohort, including patients with relatively large stone burdens. The platform’s ergonomic and assistive features appear promising for expanding fURS to larger, more complex stones. Prospective comparative trials in larger cohorts with objective ergonomic assessments are warranted to evaluate efficacy, refine surgical techniques, and define optimal patient selection criterion.