Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04534660
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2020-07-10
Brief Title:
Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler
Sponsor:
Sofregen Medical Inc
Organization:
Sofregen Medical Inc
Study Overview
Official Title:
A Feasibility Study to Evaluate Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
Active not recruiting
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:
Multicenter two clinical sites unblinded no control group prospective feasibility study Subject participation may last up to 24 months after enrollment Treatment will be performed at Day 1 and optionally at Day 30 with the primary safety and effectiveness evaluation at 2 months Subjects will continue extended follow-up evaluations at 4 6 12 18 and 24 months after the final injection
The duration and follow-up schedule will be identical independent of treatment performed
The duration and follow-up schedule will be identical independent of treatment performed
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None