Breast scaffold safety tracked for years after implant revision
NCT ID NCT07383012
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 19 women who previously received a PCL breast scaffold combined with their own fat during breast implant revision surgery. Researchers will check for device-related side effects and whether mammograms still work well with the scaffold. Participants will have annual visits for up to 5 years after their original surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PCL breast scaffold combined with autologous fat grafting
- What this could lead to
- If successful, this could show that PCL scaffolds are a safe, long-term option for breast reconstruction after implant revision, and that mammography remains reliable for screening.
- What could go wrong
- This is a small, long-term follow-up study with only 19 participants, so results may not apply to everyone. It is observational and does not test a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 19 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants who took part in the 2021-BRV-004 study, meet the eligibility criteria and provide informed consent to participate in this study
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * Patient unwilling and unable to comply with the study requirements.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)
Brisbane, Queensland, Australia, 4029, Australia
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