A single-arm, multicenter interventional clinical study will be conducted. The objective is to evaluate the safety and efficacy of the cryolipolysis technique. Approximately 372 participants will be included. After analyzing the items listed above, the participants in each study will be divided into 3 distinct intervention groups. The individuals included in the study will undergo anamnesis and data collection.
The participants in each study will be divided into 3 distinct intervention groups (Grupo 1: aplicador 360° M - Região abdominal; Grupo 2: aplicador 360° G - Região abdominal; Grupo 3: aplicador de placas - Região dos flancos). After analyzing the inclusion and exclusion criteria of this study, the individuals included in the study will undergo anamnesis and data collection after the procedure and 6 weeks and 20 weeks after: photographic capture, bioimpedance, perimetry, adipometry and ultrasound imaging of the treated area, in addition to a pain and patient satisfaction questionnaire.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
395
The procedure will take place in a session lasting a maximum of 60 minutes, which may vary depending on the amount of fat in the area and the type of applicator chosen (with or without vacuum). The patient will be comfortably positioned, in a position that facilitates suction/fixation of the applicator. An antifreeze membrane will be applied correctly to the skin, avoiding wrinkles. The marked skin area will be positioned in the center of the membrane. The applicator will be positioned in the treatment area at 90° to the skin and will activate the START.
UNDB
São Luís, Maranhão, Brazil
Clinica Franciele Doneda Estetica Integrada
Paranavaí, Paraná, Brazil
UNIFAE
São Paulo, São Paulo, Brazil
Ocurrence of adverse events after de procedure assessed by clinical evaluation
Adverse events such as erythema, pain, edema or any other event that occurs in correlation with the treatment, through monitoring in the reassessments stipulated in the study and also in a questionnaire answered by the patient
Time frame: After de procedure and 6 and 20 weeks after
% reduction in fat layer assessed by ultrasound, adipometer and photography
Adipometer: to measure the thickest point within the treatment area. For the evaluation in the abdominal region, reference points located 5 cm to the side of the umbilical scar, both on the right and left sides, will be recorded. For the evaluation in the flank region, the measurement will be standardized using the axillary midline, being performed exactly in the central fold of each flank; Ultrasound: subcutaneous tissue between the anatomical planes. The probe will be positioned at the points previously marked in the treatment area, following the same measurement performed for adipometry; Photography: at fixed angles and postures with standardized disposable underwear. Three-dimensional images will be taken of the subjects in sagittal (left and right sides) and coronal (front and back sides) views at baseline and at the stipulated follow-up periods. The abdominal region will be exposed and the subject will be instructed to remain still while the camera captures an image.
Time frame: Immediately after the procedure and 6 and 20 weeks after
Patient"s satisfaction assessed by GAIS scale
Patient satisfaction level will be categorized using the 5-point Global Aesthetic Improvement Scale (GAIS). It is divided into 5: "excellent", 4: "greatly improved", 3: "improved", 2: "no change" and 1: "worsened".
Time frame: 6 weeks and 20 weeks after the cryolipolysis procedure
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