Buttock Augmentation With Polymethylmethacrylate

August 6, 2024 updated by: MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

133

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
PMMA (polymethylmethacrylate) 30% Biosimetric
Device: PMMA
PMMA 30%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before application of PMMA and 6 and 9 months after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in normal values of laboratory biochemical tests
Time Frame: Before application of PMMA and 6 and 9 months after the procedure
laboratory biochemical exams
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
Using an ultrasound device, images of the gluteus will be obtained to analyze the thickness of the muscle, and thus estimate its volumetric capacity.
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

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.
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

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.
Up to 4, 6 and 9 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MTC_01_2024_V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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