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Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery

NCT07367698 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-07-10

No results posted yet for this study

Summary

The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation and breast augmentation revision surgery following previous breast implant insertion. The material (PCL) has been in clinical use for many decades and is absorbable. This study follows the successful completion of a 2-year evaluation of the safety and feasibility of this technique performed by the Royal Brisbane and Women's Hospital (ClinicalTrials.gov ID: NCT05437757).

The main question it aims to answer is: "Is PCL Breast Scaffold with autologous fat graft a safe and effective method for soft tissue reconstruction following breast implant revision and for primary breast augmentation?".

Participants will:

* Undergo removal of their existing silicone breast implant (only for participants undergoing breast implant revision, if the implant has not been previously removed),
* Receive implantation of a PCL Breast Scaffold combined with autologous fat grafting (AFG), and
* Attend follow-up visits at 1 week, 3 months, 6 months, and annually for up to 5 years for clinical assessments and questionnaires.

Conditions

  • Breast Implant Revision
  • Breast Augmentation Complications
  • Primary Breast Augmentation Surgery

Interventions

DEVICE

Implantation of the PCL Breast scaffold with autologous fat grafting

The PCL Breast Scaffold is implanted in a pre-pectoral pocket immediately following removal of the silicone breast implant in participants undergoing breast implant revision. For participants whose implants have been previously removed, or those undergoing primary breast augmentation, a pre-pectoral pocket is created. The use of a submuscular placement may be allowed at discretion of the PI. In conjunction with scaffold implantation, concurrent breast procedures may be performed on a case-by-case basis (e.g., Mastopexy,...). The PI will ensure accurate placement and secure fixation of the scaffold in the desired anatomical position. Autologous fat grafting (AFG) is then performed using fat cells harvested from the abdomen and/or thighs and injected into the implanted scaffold at the time of initial implantation. Then, wound closure and dressing will be conducted as per standard procedure. Sterile bandaging shall be initially applied and the wound reviewed daily whilst an inpatient.

Sponsors & Collaborators

  • BellaSeno Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Professor Owen Ung · Royal Brisbane and Women's Hospital, Herston Biofabrication Institute

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-13
Primary Completion
2032-01-31
Completion
2032-01-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07367698 on ClinicalTrials.gov