NCT06541899

Safety and Efficacy of Cryolipolysis Clinical Protocols

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: Indústria Brasileira Equipamentos Médicos - IBRAMED · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Fat Loss

Interventions

Type	Name	Description
DEVICE	Polarys Cryolipolysis	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.

Timeline

• Start date: 2023-10-04
• Primary completion: 2024-12-15
• Completion: 2024-12-15
• First posted: 2024-08-07
• Last updated: 2025-03-25

Locations

3 sites across 1 country: Brazil

Regulatory

• FDA-regulated device study