Trials / Completed
CompletedNCT01914653
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Sofregen Medical, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, single center, postmarket clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Silk surgical mesh | 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
- 2013-06-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2013-08-02
- Last updated
- 2017-10-09
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT01914653. Inclusion in this directory is not an endorsement.