NCT05345821 An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
| NCT ID | NCT05345821 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Silimed Industria de Implantes Ltda |
| Condition | Breast Implant; Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 384 participants |
| Start Date | 2022-10-05 |
| Primary Completion | 2036-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 384 participants in total. It began in 2022-10-05 with a primary completion date of 2036-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. The safety of the smooth-surfaced Silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk/adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.
Eligibility Criteria
Inclusion Criteria: * Provide written informed consent * Female at birth * Be 18 years of age or older * Have a complaint of hypomastia * Have an indication for breast augmentation with silicone implants * Ability to comply with the protocol throughout the follow-up period. Exclusion Criteria: * Replacement of breast implants due to a complication * Breast reconstruction in at least one breast * Informed pregnancy or breastfeeding at the time of inclusion * Sequelae of mastopexy * Ptosis requiring mastopexy * Breast changes or lumps rated BI-RADS 3 or higher on preoperative ultrasound or mammograms * Advanced fibrocystic disease at the time of implantation * Neoplasia of any type not yet treated or undergoing treatment at the time of implantation, - Active infection not yet treated or undergoing treatment at any site at the time of implantation * Report or record of adverse reactions or intolerance to silicone prior to implantation * Report or record of immune diseases affecting the active or undergoing treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation * Signs of inflammation of the breast or implant site at the time of implantation * Increased risk of post-implantation complications -immediate surgical complications caused by illicit drug use or medication use * Having participated in another clinical trial within 6 months prior to implant placement * Any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, make study participation unsafe, compromise protocol adherence, complicate the interpretation of study outcome data, or otherwise interfere with the achievement of study objectives
Contact & Investigator
André Luiz P de Freitas
PRINCIPAL INVESTIGATOR
Fundação do ABC - Centro Universitário FMABC
Frequently Asked Questions
Who can join the NCT05345821 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Implant; Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05345821 currently recruiting?
Yes, NCT05345821 is actively recruiting participants. Contact the research team at Pesquisaclinica@silimed.com.br for enrollment information.
Where is the NCT05345821 trial being conducted?
This trial is being conducted at Santo André, Brazil.
Who is sponsoring the NCT05345821 clinical trial?
NCT05345821 is sponsored by Silimed Industria de Implantes Ltda. The principal investigator is André Luiz P de Freitas at Fundação do ABC - Centro Universitário FMABC. The trial plans to enroll 384 participants.