Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 10:59 AM
Study NCT ID:
NCT04534660
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2020-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler
Sponsor:
Sofregen Medical, Inc.
Organization:
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:
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:
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:
False
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?: