Breast AugmentationSWIFTNCT07869641
Improved Breast Enlargement Using the Subject's Own Fat Tissue
A study testing An injectable, biodegradable hydrogel, in reconstitution medium and Reconstitution medium in people with Breast Augmentation, run by 4Tissue at 2 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation
- What is being tested?
- An injectable, biodegradable hydrogel, in reconstitution medium and Reconstitution medium
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesBelgium
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Not yet recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Filip Thiessen, Professor, MD, PhD, +3234368404, studies.plastischeheelkunde@uza.be
Filip Thiessen, Professor, MD, PhD
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Karel Claes, Professor, MD, PhD, +329 332 03 30, jozef.verbelen@uzgent.be
Karel Claes, Professor, MD, PhD
About this study
Official title: Structural Fat Grafting (SFG) With Improved Fat Transplantation
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Breast Augmentation
- Being tested
- An injectable, biodegradable hydrogel, in reconstitution medium, Reconstitution medium
- Keywords
- Breast Augmentation, Augmentation, Medical Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An injectable, biodegradable hydrogel, in reconstitution mediumDevice
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 mediumDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment with hydrogel | Experimental | Subjects undergoing Structural Fat Grafting procedure with the use of the Medical Device under investigation Receives: Device: An injectable, biodegradable hydrogel, in reconstitution medium |
| Control | Sham comparator | Subjects undergoing Structural Fat Grafting procedure without the use of the Medical Device under investigation Receives: Device: Reconstitution medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device-related adverse events recorded during the 1st month post-procedure.
Measured: From the moment the subjects undergo the procedure (structural fat grafting with or without the medical device) until the 1 month follow-up time point
Secondary outcomes (6)
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.
Measured: 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.
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)
Measured: 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)
Degradation of the Medical Device as determined by imaging (MRI).
Measured: Evaluation from 10 days post procedure to 6 months post-procedure.
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)
Measured: At all visits post-procedure (10 days, 1 month, 3 months, 6 months) compared to baseline assessment.
Change in breast volume measured by Vectra 3D, to quantify fat graft retention between the treatment group and the control group.
Measured: From 10 days to 6 months post-procedure.
Change in quality of life and subject satisfaction assessed by the Breast-Q© survey, augmentation module.
Measured: From baseline up to 1, 3 and 6 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 4Tissue
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xper Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869641
- Sponsor's protocol ID
- TISS-FIH-2025
- Other IDs
- CIV-26-01-056314
- Acronym
- SWIFT
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Fat Grafting (SFG) With Improved Fat Transplantation
- ClinicalTrials.gov ID
- NCT07869641
- Acronym / sponsor ID
- SWIFT / TISS-FIH-2025
- Conditions
- Breast Augmentation
- Keywords
- Breast Augmentation, Augmentation, Medical Device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- 4TissueIndustry (pharma, biotech, devices)
- Collaborators
- Xper Research
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with hydrogel | Experimental | Device: An injectable, biodegradable hydrogel, in reconstitution mediumSubjects undergoing Structural Fat Grafting procedure with the use of the Medical Device under investigation |
| Control | Sham comparator | Device: Reconstitution mediumSubjects undergoing Structural Fat Grafting procedure without the use of the Medical Device under investigation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An injectable, biodegradable hydrogel, in reconstitution mediumThe hydrogel is mixed with autologous fat acquired by liposuction (i.e. lipoaspirate) and then injected subcutaneously as per standard of care structural fat grafting | Device | Treatment with hydrogel |
| Reconstitution mediumThe 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 | Device | Control |
Primary outcome
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 point
6 secondary outcomes
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.
Incidence and severity acute and chronic inflammation, locally and systemically
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)
Degradation of the Medical Device as determined by imaging (MRI).
Time frame: Evaluation from 10 days post procedure to 6 months post-procedure.
Percentage of subjects with clinically significant changes in kidney and liver function.
Time frame: At all visits post-procedure (10 days, 1 month, 3 months, 6 months) compared to baseline assessment.
Change in breast volume measured by Vectra 3D, to quantify fat graft retention between the treatment group and the control group.
Time frame: From 10 days to 6 months post-procedure.
Change in quality of life and subject satisfaction assessed by the Breast-Q© survey, augmentation module.
Time frame: From baseline up to 1, 3 and 6 months post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An injectable, biodegradable hydrogel, in reconstitution medium and Reconstitution medium in people with Breast Augmentation, run by 4Tissue at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.