Breast ReconstructionNeo-MatrixNCT07480421
Clinical Evaluation of Neorepair™ Acellular Matrix in Immediate Implant-Based Breast Reconstruction
A study testing Acellular matrix in people with Breast Reconstruction, run by Silimed Industria de Implantes Ltda at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Acellular matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2026to 30 Jun 2029
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
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 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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 record of adverse reactions or intolerance to silicone;
- Any immune disorder or disease at the time of implantation;
- Depressed immune system at the time of implantation;
- Report or record of atopy at the time of implantation;
- Record or report of use of illicit drugs or medications that increase the risk of immediate post-surgical complications (e.g., medications that interfere with coagulation);
- High surgical risk or risk of complications in the immediate post-surgical period estimated before implantation;
- Evidence or report of tissue characteristics that are clinically incompatible with successful implantation (e.g., tissues with excessive fibrosis or compromised vascularization);
- Having participated in another clinical study up to 6 months before matrix placement, unless the investigator judges it to be beneficial for the participant and not impacting the study;
- Any other condition that, based on the opinion of the investigator or designated individual, may prevent the provision of informed consent, make participation in the study unsafe, compromise adherence to the protocol, complicate the interpretation of outcome data, or otherwise interfere with the achievement of the study objectives.
- Breast neoplasia where part of the treatment involves an initial surgical approach does not constitute an exclusion criterion, provided that this treatment decision is reported and that the patient is followed by an oncologist.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital de câncer HCIII (INCA)
Rio de Janeiro, Rio de Janeiro
Marcelo A Bello, +55 21 32073810, pesquisa.clinica@silimed.com.br
About this study
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.
- Conditions
- Breast Reconstruction
- Being tested
- Acellular matrix
- Keywords
- post-market, safety, performance, breast reconstruction, acellular matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular matrixDevice
Silimed® brand acellular matrix
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing breast reconstruction with Silimed® Acellular Matrix | Experimental | Not described Receives: Device: Acellular matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events of the combination of acellular matrix + Silimed® brand breast implants.
To estimate the risk and rate of expected and unexpected adverse events from the combination of acellular matrix + Silimed® brand breast implants
Measured: From enrollment to the end of study at 18 months
Performance of the combination of acellular matrix + Silimed® brand breast implants.
Evaluation of the clinical efficacy 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. Acellular Matrix is indicated for the reinforcement, repair, regeneration, and reconstruction of breast tissue in reconstructive surgeries. Its adequate integration into the recipient tissue is an essential parameter of the expected clinical performance, as it enables the incorporation of the material into the surgical bed and the success of the reconstructive process. Matrix integration will be evaluated by magnetic resonance imaging in approximately one-third of the study population. It should be noted that the degree and time of integration may vary between patients, influenced by individual factors such as biological characteristics, inflammatory response, and local.
Measured: From surgery to the end of study at 18 months
Secondary outcomes (4)
Evaluator's Satisfaction
Satisfaction with the aesthetic outcome will be assessed at all planned in-person follow-up visits. A Likert scale will be used to measure satisfaction, with the following options available: 1 = definitely dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, and 5 = definitely satisfied. In the case of responses 1 and 2, the reasons for dissatisfaction will be collected for a qualitative analysis of the conditions that determine the dissatisfaction.
Measured: From surgery to the end of study at 18 months
Participant's Satisfaction
Satisfaction with the aesthetic outcome will be assessed at all planned in-person follow-up visits. A Likert scale will be used to measure satisfaction, with the following options available: 1 = definitely dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, and 5 = definitely satisfied. In the case of responses 1 and 2, the reasons for dissatisfaction will be collected for a qualitative analysis of the conditions that determine the dissatisfaction.
Measured: From surgery to the end of study at 18 months
Patient's Quality of Life
The assessment of patient's self-esteem will be done by means of the Rosemberg Global Self-Esteem Scale, in order to evaluate the overall self-esteem of the sample. Also, the Breast Evaluation Questionnaire will be filled by them to assess breast satisfaction and changes in quality of life.
Measured: From enrollment to the end of study at 18 months
Assessment of body image
For the assessment of body image in the sample of this study, the Hopwood Body Image Scale (BIS) will be used. This instrument is a scale developed specifically for assessing body image as a dimension of quality of life.
Measured: From enrollment to the end of study at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silimed Industria de Implantes Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcelo A Belo, Principal investigator, Hospital de câncer - HCIII (INCA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480421
- Sponsor's protocol ID
- 5100
- Acronym
- Neo-Matrix
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 20 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Neorepair™ Acellular Matrix in Immediate Implant-Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT07480421
- Acronym / sponsor ID
- Neo-Matrix / 5100
- Conditions
- Breast Reconstruction
- Keywords
- post-market, safety, performance, breast reconstruction, acellular matrix
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Silimed Industria de Implantes LtdaIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 18 Mar 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing breast reconstruction with Silimed® Acellular Matrix | Experimental | Device: Acellular matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
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 |
|---|---|---|
| Acellular matrixSilimed® brand acellular matrix | Device | Women undergoing breast reconstruction with Silimed® Acellular Matrix |
Primary outcome
Adverse events of the combination of acellular matrix + Silimed® brand breast implants.
Time frame: From enrollment to the end of study at 18 months
To estimate the risk and rate of expected and unexpected adverse events from the combination of acellular matrix + Silimed® brand breast implants
Performance of the combination of acellular matrix + Silimed® brand breast implants.
Time frame: From surgery to the end of study at 18 months
Evaluation of the clinical efficacy 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. Acellular Matrix is indicated for the reinforcement, repair, regeneration, and reconstruction of breast tissue in reconstructive surgeries. Its adequate integration into the recipient tissue is an essential parameter of the expected clinical performance, as it enables the incorporation of the material into the surgical bed and the success of the reconstructive process. Matrix integration will be evaluated by magnetic resonance imaging in approximately one-third of the study population. It should be noted that the degree and time of integration may vary between patients, influenced by individual factors such as biological characteristics, inflammatory response, and local.
4 secondary outcomes
Evaluator's Satisfaction
Time frame: From surgery to the end of study at 18 months
Participant's Satisfaction
Time frame: From surgery to the end of study at 18 months
Patient's Quality of Life
Time frame: From enrollment to the end of study at 18 months
Assessment of body image
Time frame: From enrollment to the end of study at 18 months
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 20 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 Belo principal investigator
Hospital de câncer - HCIII (INCA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular matrix in people with Breast Reconstruction, run by Silimed Industria de Implantes Ltda at 1 site 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 8 inclusion and 17 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: opening soon, as of the sponsor's last update on 20 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 1 site 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 of the combination of acellular matrix + Silimed® brand breast implants. (time frame: From enrollment to the end of study at 18 months). The study lists 2 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 20 Mar 2026.