Trials / Completed
CompletedNCT01389232
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Sofregen Medical, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SeriScaffold® Surgical Scaffold | A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2013-08-01
- Completion
- 2015-02-01
- First posted
- 2011-07-08
- Last updated
- 2021-06-21
- Results posted
- 2021-06-21
Locations
5 sites across 4 countries: Germany, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01389232. Inclusion in this directory is not an endorsement.