Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction

NCT ID: NCT06981481

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-02-28

Brief 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 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Breast tissue expander

Intervention Type: DEVICE

Silimed brand breast tissue expander

Interventions

Breast tissue expander

Silimed brand breast tissue expander

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. provide written informed consent

2. female sex at birth;

3. be 18 years of age or older;

4. have an indication for reconstruction with breast expander + breast implant(s);

5. have a plan to receive an expander with a textured surface from the Silimed® brand + implant breast with textured surface from the Silimed® brand;

6. ability to comply with the protocol throughout the follow-up period.

Exclusion Criteria

1. breast augmentation without reconstruction in at least one breast;

2. neoplasia of any type (except breast neoplasia), not yet treated or under treatment, or requiring surgical removal at the time of implantation;

3. pregnancy or breastfeeding at the time of implantation;

4. smoking, uncontrolled diabetes, obesity (from grade 2) and ASA III/IV;

5. active infection not yet treated or being treated at any site at the time of implantation;

6. report or record of adverse reactions or intolerance to silicone prior to implantation;

7. immune diseases that affect connective tissue in activity or under treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation;

8. 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);

9. high surgical risk or complications in the immediate post-surgery period, estimated before the implantation;

10. evidence or report of tissue characteristics that are clinically inconsistent with a successful implantation (eg tissues with excessive fibrosis or compromised vascularization);

11. 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;

12. previous treatment with radiotherapy;

13. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Silimed Industria de Implantes Ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcelo A Bello

Role: PRINCIPAL_INVESTIGATOR

Hospital de câncer - HCIII (INCA)

Locations

Hospital de câncer HCIII (INCA)

Rio de Janeiro, Rio de Janeiro, Brazil

Fundação do ABC - Centro universitário FMABC

Santo André, São Paulo, Brazil

Countries

Brazil

Central Contacts

Maria Clara Sodré

Role: CONTACT

pesquisa.clinica@silimed.com.br

+55 21 2784-2669

Ludmila C Donato

Role: CONTACT

pesquisa.clinica@silimed.com.br

+55 21 98399-0573

Facility Contacts

Marcelo A Bello

Role: primary

pesquisa.clinica@silimed.com.br

+55 21032073810

André Luiz P de Freitas

Role: primary

pesquisa.clinica@silimed.com.br

+55 11 4993-5449

Other Identifiers

70020

Identifier Type: -

Identifier Source: org_study_id