Trials / Completed
CompletedNCT04534660
Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler
A Feasibility Study to Evaluate Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Sofregen Medical, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SMI-01 | SMI-01 is a device consisting of silk particles in a hydrogel carrier. |
Timeline
- Start date
- 2020-11-10
- Primary completion
- 2021-08-24
- Completion
- 2023-06-23
- First posted
- 2020-09-01
- Last updated
- 2024-05-31
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04534660. Inclusion in this directory is not an endorsement.