NCT07310888

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Jan 2028

First Submitted

Initial submission to the registry

December 16, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 31, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

December 16, 2025

Last Update Submit

December 16, 2025

Conditions

Stomach Cancer

Outcome Measures

Primary Outcomes (1)

  • Technical success

    Successful completion of the intended surgical procedure using the Sentire Surgical System C1000 Ultra, without conversion the treatment plan to conventional minimally invasive laparoscopic surgery or to open surgery.

    1 day

Secondary Outcomes (9)

  • Intra-operative complication

    1 day

  • Post-procedural complication

    30 days or in-hospital

  • Operative time

    1 day

  • Intraoperative blood loss

    1 day

  • Post-operative pain score

    7 days

  • +4 more secondary outcomes

Study Arms (1)

5th arm group

EXPERIMENTAL
Device: Robotic gastrectomy performed with Cornerstone Robotics Sentire Surgical System C1000 Ultra (With Patient Side Single Arm)

Interventions

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

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.

5th arm group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Fujita Health University Hospital

Nagoya, Japan

NOT YET RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Hon Chi Yip, MBChB, FRCSEd (General)

CONTACT

+852 35052956hcyip@surgery.cuhk.edu.hk

Man Yee Yung

CONTACT

+852 35052956myyung@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 16, 2025

First Posted

December 30, 2025

Study Start

December 31, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)JP(1)