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

NCT07383012 | Not Yet Recruiting DMC

• 1 other identifier: 2025-BRV-006
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast scaffold; PCL scaffold; Long-term Safety and Performance; Absorbable Implant; Regenerative Medicine; PCL breast scaffold; Mammography screening

Outcome Measures

Primary Outcomes (1)

• Assessment of moderate and severe device-related (probable and causal) AEs rate

  Number of moderate and severe AEs with a probable or causal relationship to the device falling under pre-defined category over time

  Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold

Secondary Outcomes (7)

• Breast revision surgery rate

  Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold

• Rate and severity of all AEs related to device and/or procedure

  Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold

• Total breast volume retention (3D Imaging)

  Assessed at 3- and 5-years after implantation of the PCL Breast Scaffold

• Assessment of patient satisfaction, quality of life, body image, and psychological well-being using the validated BREAST-Q questionnaire

  Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold

• Assessment of patient satisfaction, quality of life, body image, and psychological well-being using a 5-point Likert scale questionnaire

  Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold

Other Outcomes (3)

• Technical possibility of MRI for tracking scaffold degradation

  Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold

• Assessment of suitability of US (if medically indicated) screening after scaffold implantation

  Only if medically indicated between 3 and 5 years after implantation of the PCL breast scaffold.

• Biopsy, if clinically indicated, will be used for assessment of: tissue viability, tissue composition, tissue vascularisation, inflammatory response

  Reccomended 3 years after implantation of the PCL Breast Scaffold

Study Arms (1)

PCL Breast Scaffold Follow-up Group

Participants from the 2021-BRV-004 study receiving long-term follow-up assessments at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold

Eligibility Criteria

• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who took part in the 2021-BRV-004 study, meet the eligibility criteria and provide informed consent to participate in this study

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.

Sponsors & Collaborators

• BellaSeno Pty Ltd: lead

Study Sites (1)

Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)

Brisbane, Queensland, Australia, 4029, Australia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Core biopsies may be performed during the study if clinically indicated. De-identified biopsy samples will be collected and stored only after obtaining participant consent.

Study Officials

• Professor Owen Ung

  Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Owen Ung

CONTACT

+61 736460177; owen.ung@health.qld.gov.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)