Safety and Efficacy of Cryolipolysis Clinical Protocols
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 395
- 试验地点
- 6
- 主要终点
- % reduction in fat layer assessed by ultrasound, adipometer and photography
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
% reduction in fat layer assessed by ultrasound, adipometer and photography
时间窗: 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.
Ocurrence of adverse events after de procedure assessed by clinical evaluation
时间窗: 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
次要结局
- Patient"s satisfaction assessed by GAIS scale(6 weeks and 20 weeks after the cryolipolysis procedure)