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

NCT06981481 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2026-03-13

No results posted yet for this study

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

Interventions

DEVICE

Breast tissue expander

Silimed brand breast tissue expander

Sponsors & Collaborators

  • Silimed Industria de Implantes Ltda

    lead INDUSTRY

Principal Investigators

  • Marcelo A Bello · Hospital de câncer - HCIII (INCA)

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2027-08-31
Completion
2027-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06981481 on ClinicalTrials.gov