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

Starting soon

Conditions studied: Breast Implant Revision

In brief

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.

Key facts

Study ID

NCT07383012

Run by

BellaSeno Pty Ltd

People needed

19

Starts

2026-02-01

Expected to finish

2029-02-01

Last updated by the study team

2026-02-03

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients implanted with at least one PCL Breast Scaffold who took part in the 2021-BRV-004 study.
• Patients who provide written informed consent to participate in this study.

You may not qualify if…

• Patient unwilling and unable to comply with the study requirements.

Where it is running

• Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI) — Brisbane, Queensland, Australia, Australia

Full record on ClinicalTrials.gov

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