Not Yet RecruitingNot Applicable

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

Brazil100 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Provide written informed consent; * Female sex at birth; * Be 18 years of age or older; * Have an indication for reconstructive surgeries requiring reinforcement, repair, regeneration, and reconstruction of tissues in the breast region; * Have well-vascularized tissue, according to the physician's clinical assessment, for better cell infiltration, revascularization, and incorporation; * Have an indication for breast reconstruction with Silimed acellular matrix intended for subcutaneous or submuscular implantation; * Have an indication for breast reconstruction with Silimed breast implants; * Have the ability to comply with the protocol for the entire follow-up period. Exclusion Criteria: * Breast augmentation without reconstruction in at least one breast; * Neoplasia of any type that is not yet treated, or is under treatment, or requires surgical removal at the time of implantation\*; * Pregnancy or breastfeeding at the time of implantation; * Smoking, uncontrolled diabetes, obesity (grade 2 or higher) or ASA (American Society of Anesthesiology) pre-surgical classification III/IV (ANNEX I); * Active infection that is not yet treated or is under treatment at any site at the time of implantation; * Active inflammation that is not yet treated or is under treatment at the implantation site; * Report or record of adverse reactions or intolerance or known history of hypersensitivity to collagen or bovine products at the time of implantation; * Report or rec…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse events of the combination of acellular matrix + Silimed® brand breast implants.

Timeframe: From enrollment to the end of study at 18 months

Performance of the combination of acellular matrix + Silimed® brand breast implants.

Timeframe: From surgery to the end of study at 18 months

Trial details

NCT IDNCT07480421

SponsorSilimed Industria de Implantes Ltda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06-30

Contact for this trial

Renata R M Figueira

+55 21 2784-2669 pesquisaclinica@silimed.com.br

View on ClinicalTrials.gov More Breast Reconstruction trials