Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628219
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
A Global Prospective Real-World Investigation of the Symani Surgical System for Microsurgical Anastomosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Global Prospective Real-World Investigation of the Symani Surgical System for Microsurgical Anastomosis Expanding Access to Care in Free Tissue Transfer Surgery and Lymphedema Surgery
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:
PRIME
Brief Summary:
The objective of this clinical study is to evaluate the Symani Systems safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphedema surgery
The primary endpoints are
Effectiveness Clinical Success defined as intraoperative anastomosis patency
Safety Freedom from device-related serious adverse events prior to discharge from the index hospitalization as adjudicated by a Clinical Events Committee
Participants will receive treatment as standard of care and be asked to
Allow the researchers to access and use their information
If participants are undergoing a lymphedema procedure they will be asked to undergo a questionnaire as part of the study
Participants will be asked to comply with the follow-up visits as outlined in the protocol
The primary endpoints are
Effectiveness Clinical Success defined as intraoperative anastomosis patency
Safety Freedom from device-related serious adverse events prior to discharge from the index hospitalization as adjudicated by a Clinical Events Committee
Participants will receive treatment as standard of care and be asked to
Allow the researchers to access and use their information
If participants are undergoing a lymphedema procedure they will be asked to undergo a questionnaire as part of the study
Participants will be asked to comply with the follow-up visits as outlined in the protocol
Detailed Description:
None
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