Safety and Efficacy of Cryolipolysis Clinical Protocols

Indústria Brasileira Equipamentos Médicos (IBRAMED)

Status and phase: Completed; Phase 4

Conditions: Fat Loss

Treatments: Device: Polarys Cryolipolysis

Study type: Interventional

Funder types: Industry

Identifiers

NCT06541899

Ibramed_01_2024_V1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 395 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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395 participants in 3 patient groups

Group 1 - 360° M applicator, abdominal

Experimental group

Description:

Group 1: 360° M applicator - Abdominal region

Treatment:

Device: Polarys Cryolipolysis

Group 2 - 360° G applicator, abdominal

Experimental group

Description:

Group 2: 360° G applicator - Abdominal region

Treatment:

Device: Polarys Cryolipolysis

Group 3 - flanks

Experimental group

Description:

Group 3: Plate applicator - Flank region

Treatment:

Device: Polarys Cryolipolysis