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Improved Breast Enlargement Using the Subject's Own Fat Tissue

RecruitingNAAges 18 Years - 55 YearsFemale4Tissue
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult female volunteers. * Age โ‰ฅ 18 years and โ‰ค 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.
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What it tests

  • An injectable, biodegradable hydrogel, in reconstitution medium
  • Reconstitution medium
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Where

2 sites
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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