Buttock Augmentation With Polymethylmethacrylate

NCT06544304 | Not Yet Recruiting Phase 3

• 1 other identifier: MTC_01_2024_V1
• Study Type: interventional
• Target: 133
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aesthetics; Augmentation

Keywords

augmentation; gluteal

Outcome Measures

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.

  Before application of PMMA and 6 and 9 months after the procedure

Secondary Outcomes (4)

• Changes in normal values of laboratory biochemical tests

  Before application of PMMA and 6 and 9 months after the procedure

• Volumetric capacity of filled muscle assessed by ultrasound imaging

  Before application of PMMA and 6 and 9 months after the procedure

• Physician satisfaction assessed by GAIS scale

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

• Patient satisfaction assessed by GAIS scale

  Up to 4, 6 and 9 months after the procedure

Study Arms (1)

Experimental

EXPERIMENTAL

PMMA (polymethylmethacrylate) 30% Biosimetric

Device: PMMA

Interventions

PMMA DEVICE

PMMA 30%

Experimental

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA: lead

Related Publications (4)

• 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.

  PMID: 20871994 BACKGROUND

• 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.

  PMID: 20885205 BACKGROUND

• 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.

  PMID: 37241146 BACKGROUND

• 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.

  PMID: 38580866 BACKGROUND

Central Study Contacts

Carlos P Cunha

CONTACT

+55 981120522; mtcmedical@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 9, 2024
• Study Start: January 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share