Efficacy of RUS GA Surgical Navigation for Robot-assisted Distal Gastrectomy in Gastric Cancer Patients

NCT06639490 | Recruiting

• 1 other identifier: 1-2024-0044
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

This investigator-initiated, randomized superiority clinical trial aims to demonstrate the clinical effectiveness of RUS GA Surgical Navigation, an endoscopic imaging treatment planning software, in patients undergoing robotic-assisted distal gastric cancer surgery. The trial will compare the experimental group using RUS GA with a control group, aiming to show an 8.7% reduction in total surgery duration. The study will involve global multicenter patient recruitment and evaluate the clinical safety and feasibility of the software, which has been shown to be reliable in previous studies.

• Investigational Medical Device: RUS GA (Endoscopic Imaging Treatment Planning Software, E04010.01)
• Clinical Trial duration: 30 months from IRB approval -Target number of subjects: Total of 330 participants

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Surgery duration

  To assess whether the use of the endoscopic imaging treatment planning software, RUS GA, in actual surgeries of patients with gastric cancer results in a statistically significant reduction in total surgical time compared to surgeries conducted without the use of RUS GA.

  during surgery(Record anesthesia time, total operation time, and robot console time separately)

Study Arms (2)

Experimental Group A

EXPERIMENTAL

Robot-assisted gastrectomy will be performed using RUS GA

Device: RUS GA

Active Comparator Group B (standard treatment)

ACTIVE COMPARATOR

Robot-assisted gastrectomy will be performed using without software RUS GA. Only

Procedure: standard treatment

Interventions

RUS GA DEVICE

he RUS GA (Endoscopic Imaging Treatment Planning Software, E04010.01(2)) is an endoscopic imaging treatment planning software program. It creates a patient-specific simulation of the actual intra-abdominal surgical environment, allowing for the visualization of vascular structures and intra-abdominal organs during the surgical planning process and the operation. RUS GA utilizes preoperative CT images of the patient to segment organs and blood vessels and reconstructs them into a 3D model. Although there is no direct intervention with the patient, the surgeon uses RUS GA as a surgical navigation tool to simulate the surgery before performing the actual procedure.

Experimental Group A

standard treatment PROCEDURE

Only standard treatment is performed.(Robot-assisted gastrectomy will be performed using without software RUS GA.)

Active Comparator Group B (standard treatment)

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals diagnosed with gastric cancer and scheduled for robot-assisted gastrectomy.
• Adults aged 20 and above who are capable of independent judgment.
• Individuals capable of undergoing CT imaging according to the prescribed protocol.
• Individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form (approved by the Institutional Review Board)

You may not qualify if:

• Vulnerable individuals (those lacking decision-making capacity, illiterate individuals, pregnant women, newborns, minors under the age of 20, etc.).
• Patients who cannot undergo CT imaging according to the prescribed protocol before gastric cancer surgery (due to contrast agent allergies, creatinine levels exceeding 1.5 times the normal upper limit, claustrophobia, etc.).
• Individuals whose major gastric or intra-abdominal arterial/venous structures have been altered due to previous gastric or other abdominal surgeries (however, those with a history of intra-abdominal surgery that did not affect the stomach or major blood vessels are eligible).
• Patients with a history of residual gastric cancer from previous surgery.
• Patients who do not consent to participate in the study or withdraw their consent.
• Patients scheduled for simultaneous resection of other organs besides the stomach.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Surgery, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

min ah cho, Prof.

CONTACT

08-2-2228-2100; nestrel@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): March 22, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

KR (1)