Buttock Augmentation With Polymethylmethacrylate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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

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Aesthetics Augmentation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental

PMMA (polymethylmethacrylate) 30% Biosimetric

Group Type EXPERIMENTAL

PMMA

Intervention Type DEVICE

PMMA 30%

Interventions

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PMMA

PMMA 30%

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes