Efficacy of RUS GA Surgical Navigation for Robot-assisted Distal Gastrectomy in Gastric Cancer Patients: Global Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 90
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Republic of Korea
Department of Surgery, Yonsei University College of Medicine
RECRUITING
Seoul
Contact Information
Primary
min ah cho, Prof.
nestrel@yuhs.ac
08-2-2228-2100
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2027-03-22
Participants
Target number of participants: 330
Treatments
Experimental: Experimental Group A
Robot-assisted gastrectomy will be performed using RUS GA
Active_comparator: Active Comparator Group B (standard treatment)
Robot-assisted gastrectomy will be performed using without software RUS GA. Only
Related Therapeutic Areas
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov