Trials / Recruiting
RecruitingNCT06027996
Melodi Matrix™ in Breast Reconstruction
Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 702 (estimated)
- Sponsor
- Melodi Health, Inc. · Industry
- Sex
- Female
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Absorbable Antibacterial Matrix | Soft tissue support coated with antibiotics |
Timeline
- Start date
- 2024-08-09
- Primary completion
- 2027-12-01
- Completion
- 2028-06-01
- First posted
- 2023-09-07
- Last updated
- 2025-12-08
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06027996. Inclusion in this directory is not an endorsement.