RecruitingNot ApplicableNCT07310888

Robotic Gastrectomy With 5th Arm

Robotic Gastrectomy With a Novel 5th Arm - an International Multicenter Pilot Study

Sponsor

Chinese University of Hong Kong

Enrollment

10 participants

Start Date

Dec 31, 2025

Study Type

INTERVENTIONAL

Conditions

Stomach Cancer

Summary

This is a multicenter single arm clinical pilot study to investigate the safety and feasibility of a novel multiport Sentire Robotic Surgical System with Patient Side Single Arm (5th arm) in patients with gastric cancer undergoing robotic radical gastrectomy. 10 adult patients with newly diagnosed cancer of the stomach deemed operable would be recruited from Prince of Wales Hospital, Hong Kong and Fujita Health University Hospital, Nagoya, Japan. The primary aim of this study is to determine the feasibility of robotic surgical procedures performed using the Cornerstone Robotics Sentire Surgical System C1000 Ultra, as measured by the technical success rate of surgery, and to evaluate the safety of the procedures as measured by the incidence of perioperative complications.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates using a robotic surgery system with five robotic arms (instead of the usual four) for stomach removal surgery (gastrectomy), to see if the extra arm improves precision and outcomes for patients with stomach or gastro-oesophageal junction cancer. **You may be eligible if...** - You are between 18 and 75 years old - Your body mass index (BMI) is under 35 - You have been newly diagnosed with stomach or gastro-oesophageal junction cancer and are scheduled for a planned gastrectomy - You are willing to participate **You may NOT be eligible if...** - You have had previous abdominal surgery that would prevent minimally invasive surgery - You have a medical condition preventing general anaesthesia - You have a severe illness that significantly shortens life expectancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERobotic gastrectomy performed with Cornerstone Robotics Sentire Surgical System C1000 Ultra (With Patient Side Single Arm)

Under general anesthesia, the patient will be placed in a supine position in reverse Trendelenburg tilt. A 25-mm transumbilical incision will be made to allow placement of a GelPOINT Mini Advanced Access Platform (Applied Medical Ltd) and introduction of capno-peritoneum. Through the GelPOINT seal cap, robotic 8-10mm camera port and an accessory 12mm port will be introduced. Laparoscopic insertion of the other four ports of 8 mm for placement of robotic arms will be performed. After confirming port positions, docking of the Sentire Surgical System C1000 Ultra would be performed. The main Patient Side Robot (PSR) will be introduced from the patient's left shoulder side, while the Patient Side Single Arm will be introduced from the patient's right side. Distal gastrectomy, total gastrectomy and proximal gastrectomy will be performed according to the Japanese Treatment Guidelines of Gastric Cancer.

Locations(2)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Fujita Health University Hospital

Nagoya, Japan

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NCT07310888

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