Improved Breast Enlargement Using the Subject's Own Fat Tissue
ConditionBreast Augmentation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
Sponsor4Tissue
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
An injectable, biodegradable hydrogel, in reconstitution medium
DeviceThe 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
DeviceThe 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
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of device-related adverse events recorded during the 1st month post-procedure.
Time frame
From the moment the subjects undergo the procedure (structural fat grafting with or without the medical device) until the 1 month follow-up time pointSecondary outcomes
1
Incidence of all serious adverse events and procedure-related adverse events from the procedure to 6 months post procedure; and device-related adverse events between the 1- and 6- month follow-up period.
Time frame
Procedure-related adverse events: from the moment the subjects undergo the procedure until the 6-month follow-up time point. Device-related adverse events: from the 1-month to the 6-month follow-up time point.2
Incidence and severity acute and chronic inflammation, locally and systemically
Local inflammation: at the graft site, assessed by visual inspection of the breast area (redness) and palpation (swelling/hurts upon touching) Systemic inflammation: determined by blood analysis (CBC and CRP values)
Time frame
Local inflammation: post-operative (d0) and at all visits post-procedure (10 days, 1 month, 3 months and 6 months) Systemic inflammation: at all visits post-procedure (10 days, 1 month, 3 months and 6 months)3
Degradation of the Medical Device as determined by imaging (MRI).
Time frame
Evaluation from 10 days post procedure to 6 months post-procedure.4
Percentage of subjects with clinically significant changes in kidney and liver function.
Clinically significant * increase of ALT, AST, GGT (liver function) in the blood, * decrease of GFR (kidney function) in the blood, * increase in creatinine (kidney function) in the blood, * changes in chemical composition (pH, proteins, glucose, bilirubin, blood, leukocytes) or insoluble elements in the urine (e.g., cells, crystals) (kidney function)
Time frame
At all visits post-procedure (10 days, 1 month, 3 months, 6 months) compared to baseline assessment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
4Tissue
Lead sponsor
Xper research
Collaborator
Source ClinicalTrials.gov