Trials / Completed
CompletedNCT03744013
A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis
A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- RTI Surgical · Industry
- Sex
- Female
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
This is a post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Fortiva® 1mm | Post mastectomy immediate reconstruction |
Timeline
- Start date
- 2019-05-07
- Primary completion
- 2024-01-09
- Completion
- 2024-01-09
- First posted
- 2018-11-16
- Last updated
- 2024-05-02
Locations
6 sites across 2 countries: Germany, United Kingdom
Source: ClinicalTrials.gov record NCT03744013. Inclusion in this directory is not an endorsement.