Safety and Efficacy of Cryolipolysis Clinical Protocols

March 21, 2025 updated by: Indústria Brasileira Equipamentos Médicos - IBRAMED
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

395

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Brazil
    • MA
      • São Luís, MA, Brazil, 65075-441
        • UNDB
    • PR
      • Paranavai, PR, Brazil, 87709-180
        • Clinica Franciele Doneda Estetica Integrada
    • SP
      • São Paulo, SP, Brazil, 13870-377
        • UNIFAE

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The participant (healthy volunteer) who has read and signed the informed consent form for the study.
  • Male or female ≥ 22 years and ≤ 65 years of age.
  • Subjects with a body mass index (BMI) of 30 or less and who have a greater volume of adipose tissue in the abdomen (except precordial region) and flanks.
  • Subject has not changed in weight more than 5% of body weight in the previous month.
  • Subject agrees to maintain his/her weight (i.e., within 5%) by not making major changes in his/her diet or exercise routine during the study.
  • Subject agrees to have photographs taken of the treatment area(s) during the scheduled periods.

Exclusion Criteria:

  • Diabetes mellitus or need to administer or known history of subcutaneous injections in the area of intended treatment (e.g. heparin, insulin) in the last month;
  • Metabolic and/or liver diseases that compromise vitamin metabolism;
  • Being pregnant or planning to become pregnant during the study period (within the next 8 months);
  • Being breast-feeding or having breast-fed in the last 6 months;
  • Having a known sensitivity to cold, such as cold urticaria, Raynaud's disease, chilblains (pernio) or any known condition with a response to cold exposure that limits blood flow to the skin;
  • Irritated skin or presence of dermatitis;
  • Keloids or propensity for keloids in the area to be treated;
  • Having a history of hernia in the area(s) to be treated.
  • Any dermatological conditions, such as moderate to excessive skin laxity, or scarring at the location of the treatment sites that may interfere with treatment or evaluation (stretch marks are not an exclusion);
  • Have a history of a bleeding disorder or are taking any medications that, in the opinion of the investigator, may increase the risk of bruising;
  • Recent surgery at the treatment site;
  • Regular use of anti-inflammatory medications;
  • Are taking or have taken any pills or dietary supplements within the past month.
  • Invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the intended treatment area;
  • Implanted electronic devices (e.g., pacemaker);
  • Are currently enrolled in a clinical trial of any unapproved investigational drug or device.
  • Any other condition or laboratory value that could, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or pose an unacceptable risk to the subject.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 - 360° M applicator, abdominal
Group 1: 360° M applicator - Abdominal region
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.
Other Names:
  • Cryolipolysis
Experimental: Group 2 - 360° G applicator, abdominal
Group 2: 360° G applicator - Abdominal region
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.
Other Names:
  • Cryolipolysis
Experimental: Group 3 - flanks
Group 3: Plate applicator - Flank region
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.
Other Names:
  • Cryolipolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocurrence of adverse events after de procedure assessed by clinical evaluation
Time Frame: After de procedure and 6 and 20 weeks after
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
After de procedure and 6 and 20 weeks after
% reduction in fat layer assessed by ultrasound, adipometer and photography
Time Frame: Immediately after the procedure and 6 and 20 weeks after
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.
Immediately after the procedure and 6 and 20 weeks after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient"s satisfaction assessed by GAIS scale
Time Frame: 6 weeks and 20 weeks after the cryolipolysis procedure
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".
6 weeks and 20 weeks after the cryolipolysis procedure

Collaborators and Investigators

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

Sponsor

Indústria Brasileira Equipamentos Médicos - IBRAMED

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 (Actual)

October 4, 2023

Primary Completion (Actual)

December 15, 2024

Study Completion (Actual)

December 15, 2024

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ibramed_01_2024_V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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