Trials / Completed
CompletedNCT02562170
Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Medical University of Vienna · Academic / Other
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TiLoop Bra | |
| DEVICE | Protexa |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2015-04-01
- Completion
- 2015-05-01
- First posted
- 2015-09-29
- Last updated
- 2015-09-29
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT02562170. Inclusion in this directory is not an endorsement.