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RECRUITING
NCT07310888
NA

Robotic Gastrectomy With 5th Arm

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-12-31

Completion Date

2028-01-31

Last Updated

2025-12-30

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Robotic 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