IDEAL-D Phase 0 Evaluation of the Avatera System in Robot-Assisted Prostate, Bladder and Renal Surgery

Pyeloplasty Upper urinary tract
DOI: 10.1089/lap.2023.0454 Publication Date: 2024-01-22T17:33:07Z
ABSTRACT
Purpose: To evaluate the utilization of novel Avatera system in urological operations according to IDEAL-D framework recommendations for high-risk invasive surgical devices. Materials and Methods: Three surgeons attempted perform 23 upper lower urinary tract on human cadavers live porcine models using system. Total operative time duration substeps were evaluated. Surgical performance was assessed with Global Evaluative Assessment Robotic Skills (GEARS) score. Suturing rated technical checklist assessment suturing robotic surgery. Attending their satisfaction a scale 1–5. Results Limitation: Seventeen out 18 performed completed, while one pyeloplasty discontinued. All five completed. Although 1 pig euthanized fifth postoperative day, its symptoms unrelated Mean GEARS scores 29 ± 0.7 29.5 0.95, respectively, 28.5 1.2 0.5, respectively. Surgeons' high or very all procedures. Conclusions: The associated good surgeons' rates. procedures shown be feasible, comparable risks other robot-assisted surgery systems.
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