Evaluation of a new robotic surgical system for major gastrointestinal and urologic surgeries
Official title: Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery
Run by Chinese University of Hong Kong · NCT06926374 · Data updated 2026-11-12
This study is testing a new robotic surgery system to see if it can safely and effectively help patients with major gastrointestinal and urologic conditions like colorectal and prostate cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Status | Recruiting |
| Started | March 25, 2025 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | April 16, 2025 |
| Trial ID | NCT06926374 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with colorectal carcinoma, rectal prolapse, prostate cancer, bladder cancer, or kidney cancer who are suitable for minimally invasive surgery.
✕Probably not a fit
Patients with contraindications to general anesthesia, severe concomitant illnesses, or those requiring emergency surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the Sentire Surgical System, a new robotic surgical technology developed by Cornerstone Robotics Limited, aimed at performing major gastrointestinal and urologic surgeries. The study focuses on patients with conditions such as colorectal carcinoma, prostate cancer, and bladder cancer, assessing the system's effectiveness and safety compared to existing robotic systems. Participants will undergo robotic-assisted surgeries, and the trial will monitor outcomes such as success rates and complication rates. The goal is to provide a cost-effective alternative to current robotic surgical options while maintaining high standards of care.
Why it matters
Potential benefit: If successful, this study could provide patients with access to advanced robotic surgical techniques at a lower cost.
How similar studies have gone: Previous studies have shown success with robotic-assisted surgeries, but the Sentire system represents a novel approach in this field.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, China Recruiting
Study contacts
- Principal investigator: Simon SM Ng, MD — Chinese University of Hong Kong
- Study coordinator: Simon SM Ng, MD
- Email: simonng@surgery.cuhk.edu.hk
- Phone: +852-35051495
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.