Evaluation of the safety and efficacy of the Sentire Surgical System (C1000) for robot-assisted radical prostatectomy.

Abstract

Introduction: This prospective clinical study evaluated the clinical safety and efficacy of the Sentire Surgical System (C1000), a locally developed robotic surgical platform, in performing radical prostatectomy in Hong Kong.

Methods: This was a single-centre, single-arm study. Adult patients with a clinical diagnosis of localised prostate cancer planned for surgical treatment were invited to participate. Surgery was performed using the Sentire C1000 system following the standard approach. The primary endpoints were the conversion rate and the incidence of perioperative complications within 30 days. Secondary outcomes, including perioperative, pathological, oncological, and functional outcomes at 1 month after surgery, were also assessed.

Results: From August 2022 to September 2023, 20 patients were recruited. All procedures were performed without conversion. There were no intraoperative complications related to the robotic device. Minor surgical complications (Grade I-II according to the Clavien-Dindo Classification) occurred in seven patients and were managed conservatively. The mean total operative time was 184.5 minutes (standard deviation=30.0). The median estimated blood loss was 175.0 mL (interquartile range [IQR]=100.0-275.0). The median length of hospital stay was 3.0 days (IQR=2.0-4.0). Seventeen patients achieved undetectable levels of prostate-specific antigen at 1 month after surgery.

Conclusion: These initial results support the Sentire Surgical System (C1000), Hong Kong's first locally developed multidisciplinary surgical robotic platform, as a safe and effective option for radical prostatectomy, with clinical performance and outcomes comparable to existing robotic systems.