Condition: Safety and Performance · Breast Tissue Expander · Sponsor: Silimed Industria de Implantes Ltda
The study investigates the safety and performance of Silimed® brand breast tissue expander in women born with indication for breast reconstruction. The safety of the breast tissue expander will be evaluated by estimating known and unexpected adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand breast tissue expander will be evaluated by evaluating the assessment of tissue quality and satisfaction by the evaluating physician after implantation.
This description comes directly from the study's public registry record.
Renata R M Figueira · +55 21 2784-2669 · pesquisaclinica@silimed.com.br
Ludmila C Donato · +55 21 98399-0573 · pesquisaclinica@silimed.com.br
Always discuss trial participation with your own doctor first.
| Hospital de câncer HCIII (INCA) | Rio de Janeiro, Rio de Janeiro, Brazil | Recruiting |
| Fundação do ABC - Centro universitário FMABC | Santo André, São Paulo, Brazil | Not Yet Recruiting |
| Irmandade Santa Casa de Misericórdia de São Paulo | São Paulo, São Paulo, Brazil | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06981481