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Safety and Efficacy of Cryolipolysis Clinical Protocols

NCT06541899 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

  • Fat Loss

Interventions

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.

Sponsors & Collaborators

  • Indústria Brasileira Equipamentos Médicos - IBRAMED

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-04
Primary Completion
2024-12-15
Completion
2024-12-15
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06541899 on ClinicalTrials.gov