Trials / Not Yet Recruiting
Not Yet RecruitingNCT07135596
Effectiveness and Safety of OviTex® PRS in Breast Reconstruction
Research on the Effectiveness and Safety of Treatment With OviTex® PRS - a Breast Reconstruction Evaluation
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 235 (estimated)
- Sponsor
- Tela Bio Inc · Industry
- Sex
- Female
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OviTex PRS | A multi-layer construct of extracellular matrix (ECM) derived from ovine forestomach and embroidered with polymer filament. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2030-06-01
- Completion
- 2034-06-01
- First posted
- 2025-08-22
- Last updated
- 2026-02-06
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07135596. Inclusion in this directory is not an endorsement.