Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099015
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-17
Brief Title:
Cera Vascular Plug System Post-Market Clinical Follow-Up
Sponsor:
Lifetech Scientific Shenzhen Co Ltd
Organization:
Lifetech Scientific Shenzhen Co Ltd
Study Overview
Official Title:
Cera Vascular Plug System Post-Market Clinical Follow-Up A Multi-center Prospective Observational Single-arm Open-label Post-market Study
Status:
RECRUITING
Status Verified Date:
2024-09
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 objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera Vascular Plug System to
confirm the performance
confirm the safety
identify previously unknown side-effects
monitor the identified side-effects related to the procedures or to the medical devices
identify and analyse emergent risks
confirm the performance
confirm the safety
identify previously unknown side-effects
monitor the identified side-effects related to the procedures or to the medical devices
identify and analyse emergent risks
Detailed Description:
Lifetech Cera Vascular Plug System is indicated for arterial and venous embolization in the peripheral vasculature This study planned under the MDR requirements aims to confirm the safety and performance of the Lifetech Cera Vascular Plug System identify previously unknown side-effects monitor the identified side-effects related to the procedures or to the medical devices identify and analyse emergent risks The Study intends to enroll 132 subjects The estimated enrollment period is 1 year and the expected duration of each subjects participation is 1 year ie the follow-up period Final report shall be completed in 2026
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?:
None
Is an FDA AA801 Violation?:
None