Improved Breast Enlargement Using the Subject's Own Fat Tissue

NCT07869641 | Recruiting DMC

• 2 other identifiers: TISS-FIH-2025CIV-26-01-056314
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Breast Augmentation

Keywords

Breast Augmentation; Augmentation; Medical Device

Outcome Measures

Primary Outcomes (1)

• Incidence of device-related adverse events recorded during the 1st month post-procedure.

  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.

  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: 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).

  Evaluation from 10 days post procedure to 6 months post-procedure.

• Percentage of subjects with clinically significant changes in kidney and liver function.

  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.

  From 10 days to 6 months post-procedure.

Study Arms (2)

Treatment group

EXPERIMENTAL

Subjects undergoing Structural Fat Grafting procedure with the use of the Medical Device under investigation

Device: An injectable, biodegradable hydrogel, in reconstitution medium

Control group

SHAM COMPARATOR

Subjects undergoing Structural Fat Grafting procedure without the use of the Medical Device under investigation

Device: Reconstitution medium

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

Treatment group

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

Control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 4Tissue: lead
• Xper research: collaborator

Study Sites (2)

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

BE (2)