NCT06926374 Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery
| NCT ID | NCT06926374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Colorectal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2027-04 |
Trial Parameters
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Brief Summary
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.
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 Rob