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

Inclusion Criteria4

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 Criteria8

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)

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.