Actively Recruiting
Efficacy of RUS GA Surgical Navigation for Robot-assisted Distal Gastrectomy in Gastric Cancer Patients
Led by Yonsei University · Updated on 2025-06-17
330
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of RUS GA Surgical Navigation for Robot-assisted Distal Gastrectomy in Gastric Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with gastric cancer and scheduled for robot-assisted gastrectomy
- Adults aged 20 years or older who can make independent decisions
- Able to undergo CT imaging according to the study protocol
- Understand the study purpose and content and voluntarily sign informed consent before participation
You will not qualify if you...
- Vulnerable individuals such as those lacking decision-making capacity, illiterate, pregnant women, newborns, or minors under 20 years
- Unable to undergo CT imaging as required (due to contrast allergies, high creatinine, claustrophobia, etc.)
- Previous stomach or major abdominal vessel surgery that changed these structures (except surgeries not affecting stomach or major vessels)
- History of residual gastric cancer from prior surgery
- Do not consent or withdraw consent to participate
- Scheduled for removal of organs other than the stomach during surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Surgery, Yonsei University College of Medicine
Seoul, South Korea
Actively Recruiting
Research Team
M
min ah cho, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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