Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery

Overview

Robotic assisted surgery has been performed for more than two decades with good success and safety profile. However, there was only one dominating robotic surgical system available in the past which led to high cost for robotic surgery. Recently, a new robotic surgical system (Sentire Robotic Surgical System) was introduced by researchers of The Chinese University of Hong Kong (CUHK). This new robotic surgical system aims to achieve similar outcomes and standards of robotic surgery performed using the dominating system but with a significantly lower cost. The technologic innovation and development of this new robotic system is made by the Cornerstone Robotics Limited, which is based in Hong Kong. In a pilot clinical study conducted at Prince of Wales Hospital involving 55 patients, the Sentire Robotic Surgical System had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal, upper gastrointestinal, and urologic surgery. Researchers of CUHK would therefore like to conduct another prospective study to further evaluate the efficacy and safety of Sentire Surgical System C1000 in major gastrointestinal and urologic surgery with expanded indications. It is believed that the results of this study will provide data to support its use for wide range of procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical application for minimally invasive surgery with a cost-effective model.

Detailed description

As above.

Interventions

• Procedure Robotic surgery using the Sentire Surgical System
  Robotic surgery using the Sentire Surgical System

Primary outcome measures

• Conversion rate [Time frame: Up to 1 month]
• Perioperative complications [Time frame: Up to 1 month]

Secondary outcome measures (10)

• Operative time [Time frame: Up to 1 month]
• Operative blood loss [Time frame: Up to 1 month]
• Pain scores on a visual analog scale [Time frame: Up to 1 month]
• Analgesic requirement [Time frame: Up to 1 month]
• Length of hospital stay [Time frame: Up to 1 month]
• Resection margin positivity for malignancy [Time frame: Up to 1 month]
• Number of lymph nodes harvested [Time frame: Up to 1 month]
• Anal continence after surgery, measured by the Cleveland Clinic Incontinence Score (Wexner's Score) [Time frame: Up to 12 months]
• Male sexual function after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire) [Time frame: Up to 12 months]
• Urinary function after surgery, measured by the International Prostate Symptom Score (IPSS) [Time frame: Up to 12 months]

Eligibility criteria

General Inclusion Criteria for All Procedures:

• Body mass index <35 kg/m2
• Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases
• Willingness to participate as demonstrated by giving informed consent

General Exclusion Criteria for All Procedures:

• Contraindication to general anesthesia
• Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
• Untreated active infection
• Noncorrectable coagulopathy
• Presence of another malignancy or distant metastasis
• Emergency surgery
• Vulnerable population (e.g., mentally disabled, pregnancy)

Robotic Colorectal Resection

Inclusion criteria

\- Adenocarcinoma or large adenoma (not amenable to endoscopic removal) located at the colorectum (from the cecum to the anal verge) amenable to minimally invasive surgery

Exclusion criteria

• T4 tumor
• Recurrent tumor
• Extensive previous abdominal surgery precluding minimally invasive surgery

Robotic Transanal Total Mesorectal Excision

Inclusion criteria

\- Mid/low rectal adenocarcinoma located <12 cm from the anal verge

Exclusion criteria

• T4 tumor or involvement of circumferential resection margin even after neoadjuvant therapy
• Tumor requiring multivisceral resection
• Tumor requiring abdominoperineal resection; recurrent rectal tumor
• T1 tumor that can be treated by local excision
• Extensive previous abdominal surgery

Robotic Rectopexy

Inclusion criteria

• Clinically diagnosed with previously untreated and uncomplicated rectal prolapse or enterocele

Exclusion criteria

\- Extensive previous abdominal surgery precluding minimally invasive surgery

Radical Prostatectomy

Inclusion criteria

\- Clinically diagnosed with nonmetastatic adenocarcinoma of prostate

Exclusion criteria

\- Previous history of prostate surgery (e.g., transurethral resection of prostate)

Total or Partial Nephrectomy

Inclusion criteria

\- Clinically diagnosed with nonmetastatic kidney cancer

Exclusion criteria

• Previous ipsilateral kidney surgery
• Complex kidney anatomy (e.g., horseshoe kidney, complex renal vascular anatomy)

Radical Cystectomy

Inclusion criteria

\- Clinically diagnosed with nonmetastatic bladder cancer

Robotic Esophageal Hiatal Surgery and Fundoplication

Inclusion criteria

\- Clinically diagnosed with Hiatal Hernia and / or Gastroesophageal reflux disease amendable to fundoplication

Exclusion criteria

\- Previous history of laparotomy precluding minimally invasive surgery

Robotic Gastrectomy

Inclusion criteria

\- Clinical diagnosis of gastric tumor (Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)) amendable to minimally invasive radical gastrectomy

Exclusion criteria

\- Previous history of laparotomy precluding minimally invasive surgery

Robotic Esophagectomy

Inclusion criteria

\- Clinical diagnosis of carcinoma of esophagus amendable to minimally invasive esophagectomy

Exclusion criteria

\- Esophageal carcinoma after definitive chemoradiotherapy and indicated for salvage esophagectomy

Robotic Cholecystectomy

Inclusion criteria

\- Symptomatic gallbladder stones clinically indicated for laparoscopic cholecystectomy

Exclusion criteria

• Acute cholecystitis
• Previous history of abdominal surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Prince of Wales Hospital, The Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT06926374 · CREC 2025.109-T

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗