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Robotic Gastrectomy With 5th Arm

NCT07310888 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-30

No results posted yet for this study

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.

Conditions

  • Stomach Cancer

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-12-30
Completion
2028-01-31

Countries

  • Hong Kong
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07310888 on ClinicalTrials.gov