Trials / Completed
CompletedNCT00619762
Immediate Postmastectomy Breast Reconstruction (Strattice Breast)
A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 17 (actual)
- Sponsor
- LifeCell · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with the use of LTM in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.
Detailed description
nothing to add
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LTM - a porcine-based surgical mesh | Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2009-10-01
- Completion
- 2009-12-01
- First posted
- 2008-02-21
- Last updated
- 2016-11-08
- Results posted
- 2013-05-15
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00619762. Inclusion in this directory is not an endorsement.