NCT Number: NCT07383012
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 opening soon.
Get NotifiedFemale
Observational
Brisbane, Queensland, Australia, 4029, Australia
Dr Michael Wagels
SUB_INVESTIGATOR
Professor Karin Steinke
SUB_INVESTIGATOR
Professor Owen Ung
CONTACT
Professor Owen Ung
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Number of moderate and severe AEs with a probable or causal relationship to the device falling under pre-defined category over time
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Number of breast revision surgeries categorized by reason and time
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Number of AEs categorised by relationship with device and/or procedure (possible, probable, causal), severity and type over time
Time frame: Assessed at 3- and 5-years after implantation of the PCL Breast Scaffold
Total breast volume primarily assessed through 3D imaging. Supportive data generated by:
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Patient-reported outcomes will be measured using the validated BREAST-Q questionnaire. Results are reported as a transformed score range from 0 to 100, with higher scores reflecting a better outcome.
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Patient-reported outcomes will be measured through a 5-point Likert scale questionnaire. Scores range from 1 to 5, with higher scores indicating better outcomes.
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
The 5-point Likert scale questionnaire is administered to the PI. Scores range from 1 to 5, with higher scores indicating greater surgeon satisfaction.
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Visibility of glandular breast tissue; visibility of all regions of interest required for effective screening; any interference caused by the scaffold that may affect the sensitivity and specificity of the diagnostic method; visibility of the scaffold or regenerated tissue; visibility of any findings previously detected by (DCE-)MRI; and visibility of any liquid formation or seroma, if present.
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Visibility of ongoing degradation compared to previous visit through DCE-MRI
Time frame: Only if medically indicated between 3 and 5 years after implantation of the PCL breast scaffold.
Visibility of all regions of interest required for effective screening; any interference caused by the scaffold that affects the Color Doppler US reporting; visibility of the scaffold or regenerated tissue; visibility of any findings previously detected by DCE-MRI; and visibility of any liquid formation or seroma, including estimation of US-based calculated volume when present.
Time frame: Reccomended 3 years after implantation of the PCL Breast Scaffold
Assessments include tissue viability (presence of viable cells and observation of any necrotic tissue), tissue composition (tissue type, presence of calcifications or oil cysts), tissue vascularization (presence of blood vessels), and inflammatory response (presence of inflammation and whether it is acute or chronic)
Contact information is provided by the study sponsor or research team.
BellaSeno Pty Ltd
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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