Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal … (NCT06926374) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery
China90 participantsStarted 2025-03-25
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* Cl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.