Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362070
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-03
Brief Title:
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy
Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Organization:
Azienda Ospedaliera Universitaria Integrata Verona
Study Overview
Official Title:
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy COMPAR-G in Gastric Cancer Patient
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy with multiple platforms
DaVinci
Hugo
Versius
This study is divided into two phases in the first phase gastrectomy will be performed using both the new platforms Hugo and Versius and the standard platform Da Vinci to evaluate the feasibility of the surgical procedure In the second phase the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon expert in laparoscopic surgery but not with robotic one
The questions it aims to answer are
Are differences intra-operative post-operative oncological functional technical and economic among the three different platforms observable
Are there any differences between the three platforms related to the learning curve for surgeons
Participants will be enrolled after obtaining informed consent in one of the following cohorts
1 surgery with the daVinci platform
2 surgery with the Hugo platform
3 surgery with the Versius platform
DaVinci
Hugo
Versius
This study is divided into two phases in the first phase gastrectomy will be performed using both the new platforms Hugo and Versius and the standard platform Da Vinci to evaluate the feasibility of the surgical procedure In the second phase the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon expert in laparoscopic surgery but not with robotic one
The questions it aims to answer are
Are differences intra-operative post-operative oncological functional technical and economic among the three different platforms observable
Are there any differences between the three platforms related to the learning curve for surgeons
Participants will be enrolled after obtaining informed consent in one of the following cohorts
1 surgery with the daVinci platform
2 surgery with the Hugo platform
3 surgery with the Versius platform
Detailed Description:
Gastrectomy for gastric cancer could be performed through open laparoscopic and robotic approaches In the last ten years robotic surgery performed with Da Vinci Robotic System Intuitive Surgical Inc Sunnyvale CA USA has been introduced and increasingly used globally also in the field of gastric surgery Indeed the technological implementation obtained with the use of robotic surgery should guarantee an easier approach to the different phases of gastric surgery and in particular to the more complex steps relating to the reconstructive phase of the operation
Recently after Intuitive patent expiration two new CE-marked robotic platforms are available in Europe for minimally invasive procedures
Versius Robotic Surgery System Cambridge Medical Robotics CMR Ltd Cambridge UK
HugoTM RAS Medtronic Dublin Ireland Minneapolis MN USA
Both platforms are currently used for urological and gynecological procedures but no experiences are reported in Literature related to the field of oncological esophago-gastric surgery In order to provide evidence regarding the new robotic platforms the COMPAR-G study has been designed to directly compare the Da Vinci as standard Versius and HugoTM RAS robotic platforms during gastrectomy
In this regard this study was proposed divided into two phases a first phase for feasibility of surgical procedure with different platforms and the second one to evaluate the learning curve for surgeons
This second phase will be carried out only in the event of an extension of the rental of the two new platforms for a further period of one year
Recently after Intuitive patent expiration two new CE-marked robotic platforms are available in Europe for minimally invasive procedures
Versius Robotic Surgery System Cambridge Medical Robotics CMR Ltd Cambridge UK
HugoTM RAS Medtronic Dublin Ireland Minneapolis MN USA
Both platforms are currently used for urological and gynecological procedures but no experiences are reported in Literature related to the field of oncological esophago-gastric surgery In order to provide evidence regarding the new robotic platforms the COMPAR-G study has been designed to directly compare the Da Vinci as standard Versius and HugoTM RAS robotic platforms during gastrectomy
In this regard this study was proposed divided into two phases a first phase for feasibility of surgical procedure with different platforms and the second one to evaluate the learning curve for surgeons
This second phase will be carried out only in the event of an extension of the rental of the two new platforms for a further period of one year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None