Robotic gastrectomy using a patient-side 5th robotic arm
Robotic Gastrectomy With a Novel 5th Arm - an International Multicenter Pilot Study
This trial will try a new multiport robotic system with an extra patient-side arm for adults with operable stomach cancer to see if the surgery works well and is safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | Cart |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT07310888 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, single-arm pilot enrolling 10 adults with newly diagnosed operable stomach or gastro-esophageal junction cancer to undergo robotic radical gastrectomy using the Cornerstone Sentire Surgical System C1000 Ultra with a patient-side single (5th) arm. Surgeons will perform elective proximal, distal, or total gastrectomy with the device, and the study will record technical success of the procedures and perioperative complications. Outcomes include the technical success rate, incidence of intra- and postoperative complications, and feasibility signals to guide larger studies. Patients will be recruited at Prince of Wales Hospital (The Chinese University of Hong Kong) and Fujita Health University Hospital (Nagoya, Japan).
Who should consider this trial
Good fit: Adults aged 18–75 with newly diagnosed, operable stomach or gastro-esophageal junction cancer planned for elective gastrectomy and with BMI under 35 who can give informed consent are ideal candidates.
Not a fit: Patients with prior abdominal surgery that prevents minimally invasive gastrectomy, distant metastasis or another active malignancy, severe comorbidity, contraindication to general anesthesia, active untreated infection, noncorrectable coagulopathy, pregnancy, or those requiring emergency surgery are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the device could improve precision and ergonomics in minimally invasive gastrectomy and potentially reduce surgical trauma and complications.
How similar studies have performed: Robotic gastrectomy using established systems has shown benefits compared with open surgery, but the Cornerstone Sentire system with a patient-side 5th arm is a novel platform and this configuration is largely untested in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 * Body mass index \<35 kg/m2 * Newly diagnosed tumors of the stomach / gastro-esophageal junction, scheduled to undergo elective gastrectomy (Proximal gastrectomy, distal gastrectomy, total gastrectomy) * Willingness to participate as demonstrated by giving informed consent Exclusion Criteria: * Previous abdominal surgery precluding performance of MIS gastrectomy * 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)
Where this trial is running
Hong Kong and 1 other locations
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
- Fujita Health University Hospital — Nagoya, Japan (Not_yet_recruiting)
Study contacts
- Study coordinator: Hon Chi Yip, MBChB, FRCSEd (General)
- Email: hcyip@surgery.cuhk.edu.hk
- Phone: +852 35052956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.