Safety and PerformanceSTEPS-RNCT06981481
Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction
An observational study of Safety and Performance and Breast Tissue Expander, run by Silimed Industria de Implantes Ltda at 3 sites in Brazil.
Trial 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 evaluated by estimating known and unexpected adverse event rates through patient reports of adverse events after… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Safety and Performance, Breast Tissue Expander
- What is being tested?
- Breast tissue expander
- Type of treatment
- Medical device
- How many people
- 152 participants
- Where
- 3 sitesBrazil
- Study dates
- 6 Aug 2025to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Born females with indication of breast reconstruction using Silimed brand breast tissue expander.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil3 sites, 3 recruiting
- Recruiting
Hospital de câncer HCIII (INCA)
Rio de Janeiro, Rio de Janeiro
Marcelo A Bello, +55 21 32073810, pesquisa.clinica@silimed.com.br
- Not yet recruiting
Fundação do ABC - Centro universitário FMABC
Santo André, São Paulo
André Luiz P de Freitas, +55 11 4993-5449, pesquisa.clinica@silimed.com.br
- Recruiting
Irmandade Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, 01221-020
Vilmar M de Oliveira, +55 11 21761819, pesquisaclinica@silimed.com.br
Vilmar M de Oliveira
About this study
Official title: Post-marketing Clinical Monitoring of Safety and Performance of the Silimed® Brand Breast Tissue Expander for Breast Reconstruction
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.
- Conditions
- Safety and Performance, Breast Tissue Expander
- Being tested
- Breast tissue expander
- Keywords
- post-market, safety, performance, Breast tissue expander, breast reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast tissue expanderDevice
Silimed brand breast tissue expander
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing breast reconstruction with Silimed® breast tissue expander. | Women undergoing breast reconstruction with Silimed® brand breast tissue expander since the elegibility criterea was attended. Receives: Device: Breast tissue expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Estimate adverse events rate for breast tissue expander
Measured: Through study completion, an average of 1 year
Evaluator's Satisfaction in Relation to expansion
Estimate the performance of Silimed® brand breast tissue expander with through the satisfaction of the evaluator (investigator) regarding the result of the expansion so far. The assessment will be done by means of a likert scale, where the following satisfaction options can be selected: 1 = definitely unsatisfied, 2 = unsatisfied, 3 = slightly satisfied, 4 = satisfied and 5 = definitely satisfied.
Measured: Through study completion, an average of 1 year
Evaluator's Assessment of tissue quality
The assessment of tissue quality is clinical and will occur at every visit, including the final assessment. Estimate the performance of Silimed® brand breast tissue expander with textured surface throught the satisfaction of the evaluator regarding the vascularization, innervation, color and texture of and quality of the expanded tissue.
To measure satisfaction, a Likert scale where the following satisfaction options can be marked: 1 = definitely dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied and 5 = definitely satisfied.
Satisfaction will be measured in percentages of each category of the Likert scale in each follow-up time. Values from 0 to 20 will be considered poor results, bad results from 21 to 40, intermediate results from 41 to 60, good results from 61 to 80, and excellent results from 81 to 100.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start6 Aug 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silimed Industria de Implantes Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcelo A Bello, Principal investigator, Hospital de câncer - HCIII (INCA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981481
- Sponsor's protocol ID
- 70020
- Acronym
- STEPS-R
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Clinical Monitoring of Safety and Performance of the Silimed® Brand Breast Tissue Expander for Breast Reconstruction
- ClinicalTrials.gov ID
- NCT06981481
- Acronym / sponsor ID
- STEPS-R / 70020
- Conditions
- Safety and Performance, Breast Tissue Expander
- Keywords
- post-market, safety, performance, Breast tissue expander, breast reconstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Silimed Industria de Implantes LtdaIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing breast reconstruction with Silimed® breast tissue expander. | – | Device: Breast tissue expanderWomen undergoing breast reconstruction with Silimed® brand breast tissue expander since the elegibility criterea was attended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Born females with indication of breast reconstruction using Silimed brand breast tissue expander.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast tissue expanderSilimed brand breast tissue expander | Device | Women undergoing breast reconstruction with Silimed® breast tissue expander. |
Primary outcome
Adverse events
Time frame: Through study completion, an average of 1 year
Estimate adverse events rate for breast tissue expander
Evaluator's Satisfaction in Relation to expansion
Time frame: Through study completion, an average of 1 year
Estimate the performance of Silimed® brand breast tissue expander with through the satisfaction of the evaluator (investigator) regarding the result of the expansion so far. The assessment will be done by means of a likert scale, where the following satisfaction options can be selected: 1 = definitely unsatisfied, 2 = unsatisfied, 3 = slightly satisfied, 4 = satisfied and 5 = definitely satisfied.
Evaluator's Assessment of tissue quality
Time frame: Through study completion, an average of 1 year
The assessment of tissue quality is clinical and will occur at every visit, including the final assessment. Estimate the performance of Silimed® brand breast tissue expander with textured surface throught the satisfaction of the evaluator regarding the vascularization, innervation, color and texture of and quality of the expanded tissue. To measure satisfaction, a Likert scale where the following satisfaction options can be marked: 1 = definitely dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied and 5 = definitely satisfied. Satisfaction will be measured in percentages of each category of the Likert scale in each follow-up time. Values from 0 to 20 will be considered poor results, bad results from 21 to 40, intermediate results from 41 to 60, good results from 61 to 80, and excellent results from 81 to 100.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcelo A Bello principal investigator
Hospital de câncer - HCIII (INCA)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety and Performance and Breast Tissue Expander, run by Silimed Industria de Implantes Ltda at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renata R M Figueira (+55 21 2784-2669, pesquisaclinica@silimed.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.