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LTFU of PCL Breast Scaffolds Used in 2021-BRV-004

NCT07383012 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2026-02-03

No results posted yet for this study

Summary

The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with autologous fat grafting (AFG) in the 2021-BRV-004 clinical trial (ClinicalTrials.gov ID: NCT05437757). In addition, this study will investigate the suitability of mammography in the subset of patients that fall into the national breast screening age category - individuals aged 40 years and older.

The main questions this study aims to answer are:

* "Is the PCL Breast Scaffold combined with autologous fat grafting a safe and effective method of soft-tissue reconstruction following breast implant revision?"
* "Is mammography a suitable follow-up screening and diagnostic tool for patients implanted with the PCL Breast Scaffold?"

Participants will attend annual follow-up visits from 3 to 5 years after PCL Breast Scaffold implantation for clinical assessments and patient-reported outcome questionnaires.

Conditions

  • Breast Implant Revision

Sponsors & Collaborators

  • BellaSeno Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Professor Owen Ung · Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • Australia

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 NCT07383012 on ClinicalTrials.gov