Clinical trial

BREAST SCAFFOLD

Investigating a scaffold-based approach for primary breast augmentation.

Models shown in the image are for illustrative purposes only and not intended to guarantee the aesthetic results shown. Designed by Freepik

RECRUITMENT CURRENTLY UNDERWAY

Expressions of interest are being accepted for this study and future clinical research opportunities.

RESEARCH STUDY APPROACH TO PRIMARY AUGMENTATION

ABOUT THE CLINICAL TRIAL

This clinical trial is investigating the use of an absorbable, 3D-printed scaffold made from polycaprolactone (PCL) in combination with autologous fat grafting (AFG) for primary breast augmentation.

PCL is a biomaterial that has been used in a range of medical applications, including absorbable sutures. In this study, the scaffold is intended to provide temporary structural support while tissue develops within and around the scaffold.

This staged rollout ensures that we can safely and efficiently begin the trial with patients already known to our clinical team. External expressions of interest are now open, and we encourage you to register if you wish. The purpose of this research is to evaluate the safety and performance of this investigational approach. As with all clinical studies, the outcomes of participation are being studied and cannot be guaranteed. to be considered for participation or participation in future trials.

This trial investigates an approach intended to create volume and shape, working in harmony with the body as the scaffold slowly absorbs and is replaced by the body’s own tissue over time.

Submit Your Expression of Interest

Thank you for your interest in the Primary Augmentation component of this clinical research study.

If you would like to be considered for participation in this study you may submit your interest below.

The information you provide will assist the research team in assessing your eligibility and determining whether you may be suitable for screening. Submission of an Expression of Interest does not guarantee eligibility or enrolment in the study, therefore, if you would like to receive information about future clinical research opportunities, you may indicate this preference when completing your Expression of Interest form.

Please review our Privacy Policy before submitting your information.

If eligible, participation will involve:

Initial consultation – no cost.
Clinical assessment including medical history, imaging (MRI, mammography, ultrasound), photography, and 3D scanning
Follow-up assessments over 5 years, including:
- Ultrasound surveillance at 1 week
- Follow-up MRI scans at 3 months, 6 months and 12 months, 2 and 3 years (free of charge)
- 3D volumetric imaging (Vectra) at 3 months, 6 months, 1- 2- 3- and 5-years.
Reimbursement for travel and parking at each follow-up appointment
No cost for additional care required due to scaffold or fat grafting complications

While we cannot guarantee any individual benefit, participating in this trial may offer:

An improved cosmetic appearance of the native breasts without the use of a permanent silicone implant
Enhanced overall wellbeing and self-confidence
A reduced need for multiple fat injection sessions compared to traditional methods

This research also contributes to developing safer, more effective reconstruction options—potentially benefiting future patients undergoing breast reconstruction after cancer, trauma, or congenital conditions.

By avoiding silicone implants, this approach may help eliminate known risks such as rupture, capsular contracture, implant malposition, or breast implant-associated lymphoma (BIA-ALCL).

To qualify for the Breast Scaffold Trial (Clinical trial evaluating PCL breast scaffold implantation with autologous fat grafting), you will need to meet a number of eligibility requirements. At a minimum, the following criteria must be met for the initial consideration:

You are considering breast enlargement surgery
You can commit to attending follow-up visits over a 5-year period, including periodic imaging.
You are a non-smoker.

If the initial criteria are met and the surgeon determines that you are a suitable candidate, a detailed medical assessment will be conducted by the research team to determine if you fully qualify for the study based on your medical history and the results of the assessments.

Participants in this trial will have the scaffold component of the surgery covered by the trial sponsor. However, costs associated with any concurrent procedures such as a breast lift will be your responsibility.

If you meet the above minimum criteria and are interested in participating, please click on the Register Interest button to complete the required details.

Please note that meeting these initial eligibility criteria does not guarantee participation. Final participation will be determined following the submission of your interest and/or initial consultation.

To be considered for participation, you should generally meet the criteria below. Please note that submission of an Expression of Interest does not guarantee eligibility. A detailed medical assessment will be conducted by the research team to determine whether you meet all criteria for the study. Other considerations for study qualification are if you;

Hold private health insurance that provides cover for any additional standard-of-care procedures (for example: mastopexy) or be willing to self-fund them when performed as a private patient at Macquarie University Hospital. We can work with you to provide the specific procedure codes based on your situation to share with your insurance provider to verify coverage.
Have a BMI between 20–30
Are not currently pregnant or breastfeeding or plan to become pregnant within 5 years

Prior breast or chest wall malignancy
Infection in the breast within the past 12 months
Uncontrolled endocrine disorders (diabetes) or known immune deficiencies
Serious medical conditions impacting safety or wound healing
Unable to undergo MRI scans
History of smoking (you may still be eligible, subject to review)
Allergy to polycaprolactone
Unable to give informed consent

The scaffold component of the procedure will be provided as part of the clinical trial. Participants will remain responsible for costs associated with their standard surgical care, including any concurrent procedures, such as a breast lift (mastopexy), where applicable. Such procedures may be subsidised by your private health insurer, if medically indicated, but this should be verified with your insurance company.

Initial Consultation

Your initial consultation will last approximately 45 minutes.

During this consultation, with your consent the surgeon will review your medical history and specific needs, provide detailed information about the scaffold trial, clarify any associated costs, and arrange for any necessary screening tests.

Surgery Costs For Primary Augmentation

All medications, tests, and medical care required specifically for this research study will be provided to you at no cost. This includes the scaffold, autologous fat graft (AFG), and any imaging. It is not required to have private health insurance to participate in the study, but there will be no out-of-pocket costs for any trial-related care.

Surgery Costs For Primary Augmentation and Mastopexy

All medical care related to the scaffold procedure and clinical trial will be provided at no cost to you. This includes the scaffold, autologous fat graft (AFG), and any imaging.

However, you and/or your private health insurer may be responsible for the costs of any treatment or procedures that are considered part of your usual medical care (standard of care). Standard of care refers to the treatment and procedures that your study doctor would ordinarily provide even if you were not participating in this study. If you choose to have any additional standard-of-care procedures performed at the same time (for example; mastopexy), any associated costs will be your responsibility and may be covered by your private health insurance or paid out of pocket.

Your study doctor will explain which procedures are part of the study and provided at no cost, and which procedures, if any, may be billed to you or your private health insurer.

Some private health insurance policies may not cover standard-of-care procedures when they are associated with participation in a clinical trial or related to cosmetic surgery. If you are unsure about your level of coverage, you should contact your private health insurer before deciding whether to take part in the study.

Upon initial approval by the Principal Investigator and your written consent, participants undergo a comprehensive assessment of medical history, demographics, and photography, alongside informed financial consent. Screening tests such as pathology, ultrasound (US)/mammogram, and MRI are ordered at this stage. After surgery, participants undergo follow-up visits at 1 week, 3 months, 6 months, 12 months, 2-, 3-, 4-, and 5-years, which include ultrasound, MRIs and 3D imaging at some visits to monitor progress and outcomes throughout the trial period.

There is one location in New South Wales that has been authorised to conduct the clinical trial.

Macquarie Plastic and Reconstructive Surgery Suite 301, 2 Technology Place Macquarie Park NSW 2109
Integrated Specialist Healthcare (ISH), Suite 2, Level 1, 531-533 Kingsway Miranda NSW 2228, Australia

This clinical trial is conducted at:

Macquarie University and ISHCERF Centre
Principal Investigator: Prof. Anand Deva
Sponsored by: BellaSeno Pty Ltd (Study Sponsor)

Yes. This study has been reviewed and approved by the Macquarie University Human Research Ethics Committee.

Contact:

ethics.secretariat@mq.edu.au
+61 2 9850 4430

The study follows the National Statement on Ethical Conduct in Human Research (2023) to ensure your rights, safety, and wellbeing are protected throughout the process.

Models shown in the image are for illustrative purposes only and not intended to guarantee the aesthetic results shown. Designed by Freepik

Submit Your Expression of Interest

Clinical Trial: Scaffold-Based Soft Tissue Regeneration After Breast Implant Complications at Macquarie University & ISHCERF Centre

We invite you to submit an Expression of Interest (EOI) if you would like to learn more about participation in this clinical trial. If you would like to receive information about future clinical research opportunities, you may indicate this preference when completing your Expression of Interest form.

Access to the current enrolment phase is limited to patients who have already been assessed by our clinical team and have been provided with a unique access token. If you have received a token, you may proceed to the EOI form below.

if you have not received the token,you may still register your interest for future consideration. The information you provide will assist the research team in assessing eligibility and determining appropriate next steps.

Please read our Privacy Policy further information.

TRIAL LOCATIONS

New South Wales:

Macquarie Plastic and Reconstructive Surgery Suite 301, 2 Technology Place Macquarie Park NSW 2109

Integrated Specialist Healthcare Education and Research Foundation (ISHCERF), Suite 2, Level 1, 531-533 Kingsway Miranda NSW 2228,
Australia