Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639490
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Efficacy of RUS GA Surgical Navigation for Robot-assisted Distal Gastrectomy in Gastric Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of RUS GA Surgical Navigation for Robot-assisted Distal Gastrectomy in Gastric Cancer Patients Global Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 87 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 E0401001
Clinical Trial duration 30 months from IRB approval -Target number of subjects Total of 330 participants
Investigational Medical Device RUS GA Endoscopic Imaging Treatment Planning Software E0401001
Clinical Trial duration 30 months from IRB approval -Target number of subjects Total of 330 participants
Detailed Description:
After selecting subjects and obtaining informed consent randomization will be conducted Robot-assisted gastrectomy will be performed using RUS GA or without software Clinical significance will be evaluated through outpatient follow -ups for up to one month after discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None