NCT07383012

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

Long-term Follow-up Study to Evaluate the Long-term Safety and Performance of PCL Breast Scaffolds Used for Breast Implant Revision Surgery in 2021-BRV-004

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 19 (estimated)
• Sponsor: BellaSeno Pty Ltd · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: Australia