Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432088
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-16
Brief Title:
Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System Extended Magnetic Grasper Device
Sponsor:
Levita Magnetics
Organization:
Levita Magnetics
Study Overview
Official Title:
Prospective Multi-center Single-arm Open Label Study Designed to Assess the Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System Extended Magnetic Grasper Device
Status:
RECRUITING
Status Verified Date:
2024-05
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 purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric andor hiatal hernia procedures as a liver retractor grasping the liver andor the tissue surrounding the crus of the diaphragm
Detailed Description:
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System Version 2 in patients undergoing bariatric andor hiatal hernia procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CP009 | OTHER | Levita Magnetics | None |