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

March 18, 2026 updated by: Silimed Industria de Implantes Ltda
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Women undergoing breast reconstruction with Silimed® Acellular Matrix
Device: Acellular matrix
Silimed® brand acellular matrix

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of study at 18 months
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.
From surgery to the end of study at 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluator's Satisfaction
Time Frame: From surgery to the end of study at 18 months
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.
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
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.
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
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.
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
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.
From enrollment to the end of study at 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Silimed Industria de Implantes Ltda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcelo A Belo, Hospital de câncer - HCIII (INCA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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