Overview
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.
Description
The Medical Device Under Investigation is intended to improve the outcome of Structural Fat Grafting (SFG) procedures. SFG is commonly used for breast augmentation and reconstruction purposes, and relies on transplanting a person's own fatty tissue from one site in the body to another, without the use of synthetic implants, which leaves the patient with own-body-derived breast tissue. One of the disadvantages of SFG is that a large part of the transplanted fat does not survive. As a result, patients must often undergo multiple subsequent surgeries to obtain the final desired breast volume.
The Medical Device Under Investigation ("the device") is designed to temporarily support the transplanted fat and naturally degrade over time. With this temporary support, the device aims to improve volume retention in the breast, and hence reduce the number of required surgeries in patients desiring a natural breast augmentation or reconstruction fully based on own-body-derived tissue.
This study will valuate whether use of the device is safe in humans, and give a first indication of whether it works to improve volume retention in the breast. The participants in this study will be followed up for 6 months after the surgery, with a possible extension to 9 months. The need for an extension will be decided by a Data Safety Monitory Board (DSMB). In particular, the study follows a sentinel approach, whereby the first 2 participant (one in the treatment group and the other in the control group) will be followed closely during a 10-day safety monitoring period. If no safety concerns are raised by the DSMB, the study will proceed with further participant enrollments.
The DSMB will also closely review the safety data of the 2 sentinel participants at the 6-month follow-up, and may decide to extend the study follow-up from 6 months to 9 months based on safety concerns.
Eligibility
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.
