NCT07480421

Clinical Evaluation of Neorepair™ Acellular Matrix in Immediate Implant-Based Breast Reconstruction

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Silimed Industria de Implantes Ltda · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study investigates the safety and performance of Silimed® brand acellular matriz in women born female with indication for breast reconstruction. The safety of the acellular matriz will be evaluated by estimating known and unexpected adverse event rates assessed by clinical evaluations and patient reports of adverse events after implantation in addition to monitoring integration by Magnetic Resonance Imaging (MRI). The performance of Silimed® brand acellular matriz will be evaluated by clinical effectiveness of the acellular matrix in supporting breast reconstruction, reflected by the structural and functional maintenance of the reconstructed tissue without the occurrence of major complications related to integration failure during the follow-up period. Secondary performance outcomes include: assessment of body image-related quality of life, self-esteem assessment, aesthetic and functional breast assessment, and participant satisfaction level.

Conditions

• Breast Reconstruction

Interventions

Type	Name	Description
DEVICE	Acellular matrix	Silimed® brand acellular matrix

Timeline

• Start date: 2026-07-01
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2026-03-18
• Last updated: 2026-03-20

Locations

1 site across 1 country: Brazil