Status:
NOT_YET_RECRUITING
Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction
Lead Sponsor:
Silimed Industria de Implantes Ltda
Conditions:
Safety and Performance
Breast Tissue Expander
Eligibility:
FEMALE
18+ years
Brief Summary
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 eva...
Eligibility Criteria
Inclusion
- provide written informed consent
- female sex at birth;
- be 18 years of age or older;
- have an indication for reconstruction with breast expander + breast implant(s);
- have a plan to receive an expander with a textured surface from the Silimed® brand + implant breast with textured surface from the Silimed® brand;
- ability to comply with the protocol throughout the follow-up period.
Exclusion
- breast augmentation without reconstruction in at least one breast;
- neoplasia of any type (except breast neoplasia), not yet treated or under treatment, or requiring surgical removal at the time of implantation;
- pregnancy or breastfeeding at the time of implantation;
- smoking, uncontrolled diabetes, obesity (from grade 2) and ASA III/IV;
- active infection not yet treated or being treated at any site at the time of implantation;
- report or record of adverse reactions or intolerance to silicone prior to implantation;
- immune diseases that affect connective tissue in activity or under treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation;
- record or report of use of illicit drugs or medications that increase the risk of immediate post-surgical complications (eg, medications that interfere with coagulation);
- high surgical risk or complications in the immediate post-surgery period, estimated before the implantation;
- evidence or report of tissue characteristics that are clinically inconsistent with a successful implantation (eg tissues with excessive fibrosis or compromised vascularization);
- may not have participated in another clinical study up to 6 months before placement of the expander, unless the researcher deems it to be good for the participant and not impact the study;
- previous treatment with radiotherapy;
- any other condition that, based on the opinion of the researcher or designee, may prevent the provision of informed consent, make study participation unsafe, compromise adherence to the protocol, complicate the interpretation of study outcome data or otherwise interfere with the achievement of the study objectives.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT06981481
Start Date
June 1 2025
End Date
February 28 2026
Last Update
May 20 2025
Active Locations (2)
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1
Hospital de câncer HCIII (INCA)
Rio de Janeiro, Rio de Janeiro, Brazil
2
Fundação do ABC - Centro universitário FMABC
Santo André, São Paulo, Brazil