MedTrace Logo

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

NCT06639490 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2025-06-17

No results posted yet for this study

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

Interventions

DEVICE

RUS GA

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.

PROCEDURE

standard treatment

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-03
Primary Completion
2027-02-20
Completion
2027-03-22

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT06639490 on ClinicalTrials.gov