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NOT YET RECRUITING
NCT07480421
NA

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

Sponsor: Silimed Industria de Implantes Ltda

View on ClinicalTrials.gov

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

Interventions

DEVICE

Acellular matrix

Silimed® brand acellular matrix

Locations (1)

Hospital de câncer HCIII (INCA)

Rio de Janeiro, Rio de Janeiro, Brazil