Trials / Recruiting
RecruitingNCT06575192
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
A Prospective, Multicenter, Open-Label, Non-Randomized, Controlled Pivotal Study to Evaluate the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix in Implant-Based Two Stage Prepectoral Breast Reconstruction Post-Mastectomy
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 783 (estimated)
- Sponsor
- AbbVie · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ARTIA Reconstructive Tissue Matrix | Surgical Implant |
| OTHER | No Intervention | No ADM |
Timeline
- Start date
- 2024-11-05
- Primary completion
- 2029-12-01
- Completion
- 2029-12-01
- First posted
- 2024-08-28
- Last updated
- 2026-02-24
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06575192. Inclusion in this directory is not an endorsement.