Over the past few decades, the widespread adoption of robotic surgical systems has revolutionised surgical management, particularly for radical prostatectomy.1 Enhanced visualisation, superior dexterity, and tremor filtration enable surgeons to maintain precision in the deep pelvis with better ergonomics. These advantages contribute to lower rates of positive surgical margins and biochemical recurrence, thereby reducing the need for salvage therapy.2 Evidence also shows that robotic surgery can significantly reduce postoperative complications and shorten the time to regain continence and potency.3

For the past two decades, the global market for robotic surgery has been dominated by the da Vinci Surgical System (Intuitive Surgical, Sunnyvale [CA], US). However, worldwide adoption of robotic surgery remains limited by the high costs associated with device acquisition, maintenance, and disposables. Consequently, access disparities persist worldwide, particularly exacerbating inequities in surgical care4 in low- and middle-income countries.5 Surgeons and trainees are also deprived of opportunities to acquire robotic skills, creating a bottleneck in the clinical application of advanced surgical technologies. To address this problem, a novel, high-performing yet affordable robotic surgical system is needed to expand access to the highest standards of surgical care.

The Sentire Surgical System (C1000) is a novel robotic surgical system developed by Cornerstone Robotics Limited (Hong Kong, China). It is the first locally developed surgical robot designed for multispecialty use. The system consists of three interconnected components: a Patient-Side Robot (PSR), a Surgeon Console, and a Vision Cart. The PSR has four robotic arms, on which an endoscope and up to three robotic surgical instruments can be mounted. The endoscope provides a high-resolution, three-dimensional image for the console surgeon. An array of instruments, including graspers, needle drivers, clip appliers, and scissors, can be installed depending on the operational requirements. The Surgeon Console includes two hand controls and a set of foot pedals, enabling surgeons to operate the surgical instruments and endoscope on the PSR, while applying energy through the surgical instruments. The Vision Cart includes a touchscreen display showing the endoscopic view for the assistant surgeon. It houses the energy source for monopolar and bipolar instruments, as well as the light and camera source for the endoscope.

This study aimed to evaluate the clinical safety and efficacy of the Sentire Surgical System by reporting outcomes from the first clinical trial for radical prostatectomy, as part of a multispecialty clinical study. Comparable safety and patient outcomes will provide supporting evidence for the continued development of this robotic surgical technology, facilitating its implementation and evaluation in further clinical trials.

This was a prospective, single-centre, single-arm study aligned with Stage 1 (Innovation) of the IDEAL (Innovation, Development, Exploration, Assessment, Long-term Study) framework.6 The study formed part of a multi-speciality clinical investigation to evaluate the safety and efficacy of the Sentire Surgical System for robot-assisted colorectal, upper gastrointestinal, and urological surgery (radical prostatectomy).

From August 2022 to September 2023, 20 adult men with clinically localised prostate cancer and planned radical prostatectomy were recruited. The inclusion criteria were: (1) age between 50 and 80 years; (2) clinical diagnosis of non–metastatic prostate cancer; (3) body mass index <35 kg/m²; (4) deemed suitable for minimally invasive treatment; and (5) provision of informed consent. Exclusion criteria were: (1) contraindication to general anaesthesia; (2) prior history of prostatic surgery; (3) untreated active infection; (4) uncorrected coagulopathy; (5) presence of other malignancies or distant metastases; and (6) membership in a vulnerable population.

All 20 robot-assisted radical prostatectomies were performed by four practising urological surgeons, each with extensive experience (>50 prior cases as chief surgeon). All participating surgeons had been trained in the use of the system and had prior experience performing procedures with the system on cadaveric and live porcine models.

Patients were placed under general anaesthesia in the lithotomy position. A total of four robotic ports were used. First, a 10-mm endoscope port was placed supraumbilically through an open approach. After pneumoperitoneum was established, three additional 8-mm robotic ports were inserted: one on either side of the supraumbilical port, adjacent to the left mid-clavicular line at approximately the vertical level of the umbilicus, and one along the right or left anterior axillary line, about 2 cm above the anterior iliac spine. A 12-mm assistant port was inserted opposite the most lateral robotic port, mirrored across the midline. Finally, a 5-mm assistant port was inserted between the midline and either the right or left mid-clavicular line (on the same side as the 12-mm assistant port) for suction and retraction (Fig 1).

Following port placement, the patient was placed in the Trendelenburg position. The PSR of the Sentire Surgical System, which consists of four robotic arms extending from a central column, was positioned between the patient’s legs. Figure 2 shows photos of the operating room during radical prostatectomy.

For most radical prostatectomy procedures, a 0° endoscope was used throughout. One surgeon alternated among the 0°, 30° up (for initial bladder detachment), and 30° down endoscopes (for bladder neck dissection) according to their preference. Bipolar Maryland Forceps (Cornerstone Robotics Limited, Hong Kong SAR, China) were used in the left hand, Monopolar Curved Scissors (Cornerstone Robotics Limited, Hong Kong SAR, China) in the right hand, and ExtraGrasp forceps (Cornerstone Robotics Limited, Hong Kong SAR, China) on the fourth robotic arm for traction. Left-hand and right-hand instruments were exchanged for the Large Needle Driver during vesicourethral anastomosis and other suturing tasks. The right-hand instrument could also be replaced with the Large Clip Applier for vessel ligation.

Each operation was performed using the standard transperitoneal anterior approach. Briefly, bladder dissection was carried out in the areolar tissue plane between the peritoneum and transversalis fascia after the peritoneum had been incised at the lateral borders of the urinary bladder. Dissection continued caudally to develop the retropubic space. Preprostatic fat was removed for enhanced anatomical localisation. Dissection of the endopelvic fascia was then performed. The dorsal venous complex was ligated according to surgeon preference. Bladder neck dissection followed, then dissection of the vas deferens and seminal vesicles. The posterior plane of the prostate was then dissected, continuing to the prostatic apex. Lateral dissection was performed next, with the degree of nerve sparing determined by preoperative erectile function, tumour location, and tumour grade. Apical dissection was performed and the urethra was then divided.

Haemostasis was secured by further suturing of the dorsal venous complex, if not previously completed. If indicated, pelvic lymph node dissection was performed at this stage. Posterior Rocco’s stitch reconstruction was carried out, followed by vesicourethral anastomosis with continuous sutures. After confirming watertightness, a pelvic drain was placed via the most lateral robotic port. The robot was then undocked and specimens were removed in a specimen bag through an extended camera port incision. Wounds were closed using standard techniques.

Primary endpoints included the conversion rate and the incidence of perioperative complications within 30 days. Conversion was defined as an emergent change to a conventional laparoscopic or open approach. Intraoperative events and postoperative complications during the hospital stay and within 30 days of discharge were recorded. The severity of complications was graded according to the Clavien–Dindo Classification. Whether complications were anticipated was determined based on their consistency with the current investigational plan or consent form. In the event of postoperative complications, the relationship to the Sentire Surgical System, the surgical procedure, and the patient’s underlying condition was documented, along with actions taken and outcomes.

Secondary endpoints included perioperative and pathological outcomes. Perioperative outcomes included total operative time, docking time, total console time, estimated blood loss, time to resume regular activity, length of hospital stay, time of drain and removal, time of urethral catheter removal, visual analogue scale (VAS) pain scores at 14 and 30 days, and use of pads for urinary incontinence at 14 days and 30 days. Pathological outcomes included surgical margins, lymph node metastasis, tumour involvement, pathological tumour stage, number of lymph nodes harvested, and postoperative prostate-specific antigen (PSA) level.

Data are presented in a descriptive manner. Continuous variables are reported as means with standard deviations (SDs) or medians with interquartile ranges, whereas categorical variables are presented as percentages. All analyses were performed using SPSS (Windows version 25.0; IBM Corp, Armonk [NY], US).

Twenty patients were enrolled in the trial, and all successfully underwent robot-assisted radical prostatectomy using the Sentire Surgical System. The mean age was 68.5 years (SD=4.1) and the mean body mass index was 24.2 kg/m² (SD=2.8). Two patients had a history of abdominal surgery: Case 3 had undergone open appendicectomy, and Case 11 had undergone laparoscopic cholecystectomy. Seventeen patients underwent radical prostatectomy only, while three also underwent lymphadenectomy. The mean prostate volume was 40.7 cc (SD=17.8). Nine patients had a Gleason score of 6, nine had a score of 7, and two had a score of 8. Five patients were classified as low-risk, 11 as intermediate-risk, and four as high-risk. Two patients received neoadjuvant hormonal therapy due to concerns about prolonged waiting times during the coronavirus disease 2019 period; their mean initial PSA level dropped from 16.2 ng/mL to 2.19 ng/mL. The mean preoperative PSA level for patients who did not receive neoadjuvant therapy was 15.2 ng/mL (SD=20.8) [Table 1].

All operations were completed without conversion. There were no intraoperative complications related to the robotic device. Minor surgical complications (Grade I-II) occurred in seven patients, including four cases of wound infection, one case of urinary retention, one case of prolonged anastomotic leakage, one case of bilateral lower limb rash, and one case of left loin pain. Only five of these complications—namely wound infections and prolonged anastomotic leakage—were considered related to the surgery (Table 2).

The mean total operative time (from skin incision to closure) was 184.5 minutes, including a mean docking time of 4.2 minutes and a mean total console time of 149.7 minutes. The median estimated blood loss was 175.0 mL. Postoperatively, the median time to resumption of regular activity was 7.0 days, the median duration of drainage was 2.0 days and the median duration of urethral catheterisation was 7.0 days. The median length of hospital stay was 3.0 days. The median VAS pain score at the 14-day follow-up was 3.0, whereas at the 30-day follow-up it was 0. Pad usage for urinary incontinence was 3.5 at the 14-day follow-up and 2.0 at the 30-day follow-up (Table 3).

Regarding pathological outcomes, 13 of the 20 patients (65%) had negative surgical margins, including the two who received neoadjuvant hormonal therapy. Seventeen patients (85%) had undetectable PSA levels 1 month after surgery, while two other patients (95%) achieved undetectable levels at 3 months. Among the three patients who underwent lymphadenectomy, the mean number of lymph nodes harvested was 9 (range=5-11) [Table 4].

This prospective study reports the results of the first-in-human clinical trial of the Sentire Surgical System—the first locally developed multispecialty surgical robot—used for radical prostatectomy. All 20 procedures were completed successfully, without conversions and device-related intraoperative or postoperative complications, demonstrating that this novel surgical system is safe and effective for robot-assisted radical prostatectomy.

Since the introduction of robotic surgery in Hong Kong in 2005, its use—particularly in urology—has steadily expanded.7 According to the latest Surgical Outcome Monitoring and Improvement Programme report (2022-2023), almost all radical prostatectomies (409 of 410 patients) were performed using robotic surgery.8 Improved outcomes have been a key factor supporting its development.9 However, the high cost of robotic systems considerably limits further expansion and popularisation. With the expiration of certain technological patents, new robotic systems are rapidly emerging worldwide.10 The development of a locally based robotic system in Hong Kong represents an important milestone for the future of robotic surgery in the region.

Perioperative outcomes in this trial were favourable, with a mean total operative time of 184.5 minutes, comparable to reported times in the existing literature on both laparoscopic and robotic radical prostatectomy.11 The short docking time reflected a smooth docking process. Most cases had acceptable blood loss, and no patients required transfusion, again comparable to the literature.11 Despite the higher-than-expected wound infection rate, most infections were minor and managed with simple dressing. No specific cause was identified, and these events are unlikely to be related to the robotic system. Postoperative hospital stay was also short, with satisfactorily low VAS pain scores. Early functional outcomes, specifically pad usage for urinary incontinence, were also satisfactory (Table 3).

Short-term oncological outcomes also support the system’s efficacy, such that 65% of patients achieved a negative surgical margin and 85% and 95% of patients showed no PSA persistence (PSA level ≥0.1 ng/mL) at 30 days and 3 months after surgery, respectively—results that are comparable to the literature.12 In the three cases where lymphadenectomy was performed, the mean lymph node yield was 9, which is considered optimal for balancing the biochemical recurrence-free rate and complication risk.13 These findings indicate that the system can achieve oncological outcomes in radical prostatectomy comparable to those of established robotic systems.

Compared with our previously reported outcomes using other robotic systems,14 the performance of the current system was highly comparable. The mean operative time and hospital stay were 184.5 minutes/3.1 days (Sentire C1000), 225.8 minutes/3.3 days,14 (da Vinci S), and 223.7 minutes/3.0 days,14 (da Vinci SP). These results not only demonstrate that the Sentire C1000 offers performance comparable to existing robotic systems but also confirm the ease of surgical transition. A key factor enabling this transition is the similarity of the robotic control interface—including hand controls and foot pedals, allowing surgeons to adopt the new system more readily and apply their existing robotic experience. This is akin to driving different brands of cars, where consistent interfaces such as the steering wheel and pedals enable smooth adaptation. As a result, most new robotic systems adopt similar interface designs to support seamless integration by experienced surgeons. Moreover, the PSR has a similar arm configuration and setup to the da Vinci system, which also helps both surgeons and nursing staff adapt to the setup.

As this is the initial report of the Sentire Surgical System’s clinical use in radical prostatectomy, further clinical studies are warranted to evaluate its performance across a broader range of procedures.

Our findings indicate that the Sentire Surgical System (C1000) is a safe and effective robotic platform for radical prostatectomy. Its successful performance in this first-in-human experience supports ongoing development and broader application of this novel surgical robotic system.

Concept or design: CF Ng.
Acquisition of data: CH Yee, PKF Chiu, MHM Tam, FPT Lai.
Analysis or interpretation of data: FPF Lai.
Drafting of the manuscript: CF Ng, FPF Lai.
Critical revision of the manuscript for important intellectual content: All authors.

All authors had full access to the data, contributed to the study, approved the final version for publication, and take responsibility for its accuracy and integrity.

As an editor of the journal, CF Ng was not involved in the peer review process. Other authors have disclosed no conflicts of interest.

The authors thank the support from the operating theatre staff in Prince of Wales Hospital.

The research was supported by Cornerstone Robotics Limited for equipment and research fund. The funder had no role in the study design, data collection/analysis/interpretation, or manuscript preparation.

The research was approved by the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee, Hong Kong (Ref No.: CREC 2021.472). It was registered on www.ClinicalTrials.gov (Ref No.: NCT05151835). Written informed consent was obtained from all patients for the publication of this research and the accompanying images.

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