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Improved Breast Enlargement Using the Subject's Own Fat Tissue

Sponsor: 4Tissue • ClinicalTrials.gov ID: NCT07869641

Registry updated: 2026-10-15

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Description

The goal of this clinical study is to learn if the Medical Device Under Investigation (simply "the device") is safe to use in human adults undergoing breast augmentation surgery. The study will also show if the device can improve volume retention of the breast after the surgery. In the study, breast augmentation surgery will be done by transplanting the participant's own fatty tissue from the belly or buttocks to the breast. This surgical technique is also known as Structural Fat Grafting (SFG). The main questions this clinical study aims to answer is: * Is the use of the device safe in human? * Is the device fully degraded over time? * Does the use of the device during SFG improve breast volume retention, compared to standard SFG without the device. Thereto, 20 healthy female participants between the age of 18 and 55 years old will be included in this study. Half of the participants (10 out of 20) will undergo the surgery with the use of the device (treatment group) and the other 10 participants will undergo the surgery without the use of the device (control group). Participants will be followed up for 6 months after the surgery, with a possible extension to 9 months, and visit the hospital 6 to 7 times for checkups and tests.

Interventions

An injectable, biodegradable hydrogel, in reconstitution medium (Device)
The hydrogel is mixed with autologous fat acquired by liposuction (i.e. lipoaspirate) and then injected subcutaneously as per standard of care structural fat grafting
Reconstitution medium (Device)
The reconstitution medium is mixed with autologous fat acquired by liposuction (i.e. lipoaspirate) and then injected subcutaneously as per standard of care structural fat grafting

Eligibility 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.

Conditions

Breast Augmentation

Locations

Universitair Ziekenhuis Antwerpen — Edegem, Belgium
Universitair Ziekenhuis Gent — Ghent, Belgium

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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