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Clinical Evaluation of Neorepair™ Acellular Matrix in Immediate Implant-Based Breast Reconstruction
Sponsor: Silimed Industria de Implantes Ltda
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-07-01
Completion Date
2029-06-30
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Acellular matrix
Silimed® brand acellular matrix
Locations (1)
Hospital de câncer HCIII (INCA)
Rio de Janeiro, Rio de Janeiro, Brazil