NCT06926374Recruiting
Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery
Source: ClinicalTrials.gov · Last updated 16 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 7 Apr 2025
- Start date
- 25 Mar 2025
- Primary completion date
- Apr 2027
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Prostate cancer, Kidney cancer, Bladder cancer, Colorectal cancer, Gastric and esophageal cancer
- NCT number
- NCT06926374
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 25 Mar 2025 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Extensive previous abdominal surgery precluding minimally invasive surgery
- Robotic Transanal Total Mesorectal Excision
- T4 tumor or involvement of circumferential resection margin even after neoadjuvant therapy
- Tumor requiring multivisceral resection
- Tumor requiring abdominoperineal resection; recurrent rectal tumor
- Extensive previous abdominal surgery
- Robotic Rectopexy
- \- Extensive previous abdominal surgery precluding minimally invasive surgery
- \- Previous history of prostate surgery (e.g., transurethral resection of prostate)
- Previous ipsilateral kidney surgery
- \- Previous history of laparotomy precluding minimally invasive surgery
- \- Previous history of laparotomy precluding minimally invasive surgery
- Previous history of abdominal surgery
Other
- T4 tumor
- Recurrent tumor
- T1 tumor that can be treated by local excision
- Radical Prostatectomy
- Total or Partial Nephrectomy
- Complex kidney anatomy (e.g., horseshoe kidney, complex renal vascular anatomy)
- Radical Cystectomy
- Robotic Gastrectomy
- Robotic Esophagectomy
- \- Esophageal carcinoma after definitive chemoradiotherapy and indicated for salvage esophagectomy
- Robotic Cholecystectomy
- Acute cholecystitis
Who the study is looking for
- \- 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
- \- Mid/low rectal adenocarcinoma located \<12 cm from the anal verge
- Clinically diagnosed with previously untreated and uncomplicated rectal prolapse or enterocele
- \- Clinically diagnosed with nonmetastatic adenocarcinoma of prostate
- \- Clinically diagnosed with nonmetastatic kidney cancer
- \- Clinically diagnosed with nonmetastatic bladder cancer
- Robotic Esophageal Hiatal Surgery and Fundoplication
- \- Clinically diagnosed with Hiatal Hernia and / or Gastroesophageal reflux disease amendable to fundoplication
- \- Clinical diagnosis of gastric tumor (Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)) amendable to minimally invasive radical gastrectomy
- \- Clinical diagnosis of carcinoma of esophagus amendable to minimally invasive esophagectomy
- \- Symptomatic gallbladder stones clinically indicated for laparoscopic cholecystectomy
Criteria the registry did not label
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital, The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.