Improved Breast Enlargement Using Your Own Fat Tissue
Official title: Structural Fat Grafting (SFG) With Improved Fat Transplantation
Run by 4Tissue · NCT07869641 · Data updated 2026-11-12
This study tests a temporary device to help your own fat grafting for breast enlargement stay in place and keep volume after surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | 4Tissue Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Edegem and 1 other locations) |
| Status | Recruiting |
| Started | November 2026 |
| Main results expected | April 2027 |
| Study ends | December 2027 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07869641 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adult women 18–55 years old planning breast augmentation with their own fat tissue (structural fat grafting).
✕Probably not a fit
Participants with contraindications to MRI or those not receiving the device may not experience a benefit in fat retention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety of a biodegradable device used during structural fat grafting for breast augmentation and whether it improves long-term volume retention. Twenty healthy women aged 18–55 will be randomized to receive fat transfer with or without the device during surgery. Participants will be followed for 6 months, with a possible extension to 9 months, to monitor safety and how well the transplanted fat persists. The trial uses a sentinel approach, with initial small groups to assess early results before broader conclusions are drawn. Primary outcomes focus on safety and preliminary signals of improved volume retention compared with standard fat grafting.
Why it matters
Potential benefit: If successful, the device could improve breast volume retention after fat grafting and reduce the need for additional procedures.
How similar studies have gone: Prior fat grafting approaches often require multiple surgeries due to fat loss, and this device aims to reduce that need; other studies have shown mixed success with similar strategies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult female volunteers. * Age ≥ 18 years and ≤ 55 years, clinically premenopausal. * Medically healthy as determined by the investigator, based upon medical history, concomitant medication, physical examination, blood analysis, urinalysis and MRI. * Able to read and understand the subject information sheet and able to provide written informed consent. * Willing to undergo MRIs as part of the outcome procedures. * Able and willing to comply with study-related requirements, procedures and visits. * Willing to use effective contraception throughout the study duration (for women of childbearing potential). * Willing to refrain from undergoing any other treatments (laser, cryo-therapy, etc.) to breast skin and breast subcutaneous layers during 9 months after treatment. Exclusion Criteria: * Pregnant, breastfeeding, not using contraception or not willing to use contraception throughout the course of the study. * History of kidney or liver disease. * Current use of tobacco or nicotine-containing products, current use of drugs, excessive alcohol consumption defined as more than 3 glasses/alcoholic consumptions per day. * Breast cancer (or suspicion of breast cancer). * Women who previously underwent radiotherapy (at the breast region) or chemotherapy. * Body dysmorphic disorder. * Serious psychological or psychiatric disorder. * MRI incompatibility due to claustrophobia or non-removable magnetic implants (including pacemaker and cardiac defibrillators, aneurysm clips, cochlear implants) * Known gelatin allergy or hypersensitivity. * Previous surgery or trauma near the targeted injection site, including previous prepectoral augmentation.
Where it's running
-
Universitair Ziekenhuis Gent
Ghent, Belgium Recruiting -
Universitair Ziekenhuis Antwerpen
Edegem, Belgium Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.