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Not yet recruitingNCT06544304Updated Aug 9, 2024

Buttock Augmentation With Polymethylmethacrylate

A Phase 3 interventional study of PMMA in Aesthetics and Augmentation, sponsored by MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA · Phase 3, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
133
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Aesthetics
  • Augmentation

Keywords

  • augmentation
  • gluteal
03

In context

Lead sponsor

This is the only study on the registry with MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
133 participants (estimated)

Study arms

  • Experimental
    Experimental

    PMMA (polymethylmethacrylate) 30% Biosimetric

    Device: PMMA

Interventions

  • DevicePMMA

    PMMA 30%

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before application of PMMA and 6 and 9 months after the procedure

Secondary outcomes

  1. Changes in normal values of laboratory biochemical tests

    laboratory biochemical exams

    Time frame: Before application of PMMA and 6 and 9 months after the procedure

  2. 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.

    Time frame: Before application of PMMA and 6 and 9 months after the procedure

  3. 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.

    Time frame: Before application of PMMA and 4, 6 and 9 months after the procedure

  4. 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.

    Time frame: Up to 4, 6 and 9 months after the procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

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 20871994 ↗
  • Talbot 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 20885205 ↗
  • Stojicic 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 37241146 ↗
  • Guzey 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06544304
Lead sponsor
MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Jan 2025 (estimated)
Primary completion
Feb 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Aug 9, 2024

Study contacts

Carlos P Cunha
Contact
mtcmedical@hotmail.com
+55 981120522

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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