Clinical Trial

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

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07383012
Lead Sponsor BellaSeno Pty Ltd
Conditions Breast Implant Revision
Enrollment 19 participants
Start Date 2026-02
Primary Completion 2029-02 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-02-03