AestheticsPhase 3NCT06544304
Buttock Augmentation With Polymethylmethacrylate
A Phase 3 study testing PMMA in people with Aesthetics and Augmentation, run by MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA.
Trial summary
Single-arm multicenter interventional clinical trial of buttock augmentation with polymethyl methacrylate. The objective is to evaluate the safety and effectiveness of using 30% Biosimetric PMMA gel for buttock augmentation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aesthetics, Augmentation
- What is being tested?
- PMMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 60 years old;
- Signed Informed Consent Form (ICF);
- Participant understands and is willing to participate in the clinical study and attend visits.
Who cannot join
- Known history of allergy to formula components;
- Have the following morbidities (or any other disease that may interfere with the study): chronic inflammatory disease, immunosuppression, diabetes, hypertension, autoimmune disease, dermatological disease in the region to be treated, acute or chronic renal failure, history of coronary disease, history of cerebrovascular disease, current neoplasia, mental illness undergoing psychiatric treatment, obesity with a BMI above 30, asthma, bronchitis, seizures, hepatitis or other active infectious diseases;
- Pregnancy;
- Prior filling of glutes;
- Use of acetylsalicylic acid, anti-inflammatories, anticoagulants, in the fifteen days before the procedure.
- Vitamin D supplementation, with normal serum levels and which you do not agree to suspend;
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- Use of anabolic hormones;
- Vitamin D (25 hydroxyvitamin D) greater than 70 ng/mL;
- Serum calcium greater than 10 mg/dL;
- Patients with total body PMMA volume of 650mL or more.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Interventional, Multicenter, Single-Arm Clinical Trial of Buttock Augmentation With Polymethylmethacrylate
Single-arm multicenter interventional clinical trial of buttock augmentation with polymethyl methacrylate.
The objective is to evaluate the safety and effectiveness of using 30% Biosimetric PMMA gel for buttock augmentation.
Read the detailed description
The sample will be 133 patients. Specific patients will be screened at study sites according to eligibility classifications. After signing the consent form, patients will be included in the study and will be monitored for 9 months.
- Conditions
- Aesthetics, Augmentation
- Being tested
- PMMA
- Keywords
- augmentation, gluteal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMMADevice
PMMA 30%
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | PMMA (polymethylmethacrylate) 30% Biosimetric Receives: Device: PMMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by clinical evaluation
Occurrence of adverse events in patients who underwent gluteal augmentation with 30% Biosymmetric PMMA. Expected events will be classified as adverse events when they persist for more than two weeks, and should be reported throughout the study. Adverse events not previously identified will also be monitored at all visits.
Measured: Before application of PMMA and 6 and 9 months after the procedure
Secondary outcomes (4)
Changes in normal values of laboratory biochemical tests
laboratory biochemical exams
Measured: Before application of PMMA and 6 and 9 months after the procedure
Volumetric capacity of filled muscle assessed by ultrasound imaging
Using an ultrasound device, images of the gluteus will be obtained to analyze the thickness of the muscle, and thus estimate its volumetric capacity.
Measured: Before application of PMMA and 6 and 9 months after the procedure
Physician satisfaction assessed by GAIS scale
Physician satisfaction will be assessed using the Portuguese version of the Global Aesthetic Improvement Scale, assigning values according to the following parameters:
Much improved (5): excellent cosmetic result after the procedure. Much improved (4): marked improvement in appearance from the initial condition, but not completely optimal for the patient.
Better (3): obvious improvement in appearance from the initial condition. Unchanged (2): appearance is essentially the same as the original condition. Worse (1): appearance is worse than the original condition.
Measured: Before application of PMMA and 4, 6 and 9 months after the procedure
Patient satisfaction assessed by GAIS scale
Patient satisfaction will be assessed using the Portuguese version of the Global Aesthetic Improvement Scale, assigning values according to the following parameters:
Much improved (5): excellent cosmetic result after the procedure. Much improved (4): marked improvement in appearance from the initial condition, but not completely optimal for the patient.
Better (3): obvious improvement in appearance from the initial condition. Unchanged (2): appearance is essentially the same as the original condition. Worse (1): appearance is worse than the original condition.
Measured: Up to 4, 6 and 9 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study startJan 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AestheticsStudies 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 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544304
- Sponsor's protocol ID
- MTC_01_2024_V1
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nicareta B, Pereira LH, Sterodimas A, Illouz YG. Autologous gluteal lipograft. Aesthetic Plast Surg. 2011 Apr;35(2):216-24. doi: 10.1007/s00266-010-9590-y. Epub 2010 Sep 25.
PubMed 20871994Talbot SG, Parrett BM, Yaremchuk MJ. Sepsis after autologous fat grafting. Plast Reconstr Surg. 2010 Oct;126(4):162e-164e. doi: 10.1097/PRS.0b013e3181ea4541.
PubMed 20885205Stojicic M, Jurisic M, Marinkovic M, Jovanovic M, Igic A, Nikolic Zivanovic M. Necrotizing Skin and Soft Tissue Infection after Gluteal Augmentation in a Perioperatively Asymptomatic COVID-19 Patient-Complications of the Post-Lockdown Era? A Case Report. Medicina (Kaunas). 2023 May 10;59(5):914. doi: 10.3390/medicina59050914.
PubMed 37241146Guzey S, Ergan Sahin A. Brazilian Butt Lift: An Experience Over 3000 Patients. Aesthetic Plast Surg. 2024 Jul;48(14):2677-2693. doi: 10.1007/s00266-024-03965-8. Epub 2024 Apr 5.
PubMed 38580866
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Multicenter, Single-Arm Clinical Trial of Buttock Augmentation With Polymethylmethacrylate
- ClinicalTrials.gov ID
- NCT06544304
- Acronym / sponsor ID
- MTC_01_2024_V1
- Conditions
- Aesthetics, Augmentation
- Keywords
- augmentation, gluteal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDAUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 9 Aug 2024 (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.
Single-arm multicenter interventional clinical trial of buttock augmentation with polymethyl methacrylate.
The objective is to evaluate the safety and effectiveness of using 30% Biosimetric PMMA gel for buttock augmentation.
Detailed description
The sample will be 133 patients. Specific patients will be screened at study sites according to eligibility classifications. After signing the consent form, patients will be included in the study and will be monitored for 9 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: PMMAPMMA (polymethylmethacrylate) 30% Biosimetric |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 60 years old;
- Signed Informed Consent Form (ICF);
- Participant understands and is willing to participate in the clinical study and attend visits.
Key exclusion criteria (10 listed)
- Known history of allergy to formula components;
- Have the following morbidities (or any other disease that may interfere with the study): chronic inflammatory disease, immunosuppression, diabetes, hypertension, autoimmune disease, dermatological disease in the region to be treated, acute or chronic renal failure, history of coronary disease, history of cerebrovascular disease, current neoplasia, mental illness undergoing psychiatric treatment, obesity with a BMI above 30, asthma, bronchitis, seizures, hepatitis or other active infectious diseases;
- Pregnancy;
- Prior filling of glutes;
- Use of acetylsalicylic acid, anti-inflammatories, anticoagulants, in the fifteen days before the procedure.
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 |
|---|---|---|
| PMMAPMMA 30% | Device | Experimental |
Primary outcome
Number of participants with treatment-related adverse events as assessed by clinical evaluation
Time frame: Before application of PMMA and 6 and 9 months after the procedure
Occurrence of adverse events in patients who underwent gluteal augmentation with 30% Biosymmetric PMMA. Expected events will be classified as adverse events when they persist for more than two weeks, and should be reported throughout the study. Adverse events not previously identified will also be monitored at all visits.
4 secondary outcomes
Changes in normal values of laboratory biochemical tests
Time frame: Before application of PMMA and 6 and 9 months after the procedure
Volumetric capacity of filled muscle assessed by ultrasound imaging
Time frame: Before application of PMMA and 6 and 9 months after the procedure
Physician satisfaction assessed by GAIS scale
Time frame: Before application of PMMA and 4, 6 and 9 months after the procedure
Patient satisfaction assessed by GAIS scale
Time frame: Up to 4, 6 and 9 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 20871994Nicareta B, Pereira LH, Sterodimas A, Illouz YG. Autologous gluteal lipograft. Aesthetic Plast Surg. 2011 Apr;35(2):216-24. doi: 10.1007/s00266-010-9590-y. Epub 2010 Sep 25.
- Background: PubMed 20885205Talbot SG, Parrett BM, Yaremchuk MJ. Sepsis after autologous fat grafting. Plast Reconstr Surg. 2010 Oct;126(4):162e-164e. doi: 10.1097/PRS.0b013e3181ea4541.
- Background: PubMed 37241146Stojicic M, Jurisic M, Marinkovic M, Jovanovic M, Igic A, Nikolic Zivanovic M. Necrotizing Skin and Soft Tissue Infection after Gluteal Augmentation in a Perioperatively Asymptomatic COVID-19 Patient-Complications of the Post-Lockdown Era? A Case Report. Medicina (Kaunas). 2023 May 10;59(5):914. doi: 10.3390/medicina59050914.
- Background: PubMed 38580866Guzey S, Ergan Sahin A. Brazilian Butt Lift: An Experience Over 3000 Patients. Aesthetic Plast Surg. 2024 Jul;48(14):2677-2693. doi: 10.1007/s00266-024-03965-8. Epub 2024 Apr 5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PMMA in people with Aesthetics and Augmentation, run by MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA.
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 3 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos P Cunha (+55 981120522, mtcmedical@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by clinical evaluation (time frame: Before application of PMMA and 6 and 9 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06544304, which also lists 4 linked publications.
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 9 Aug 2024.