NCT04876118已完成不适用
Feasibility Study of CoolSculpting Effects on Cellulite Appearance
Zeltiq Aesthetics12 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2020年11月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 12
- 主要终点
- Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel
研究概览
简要总结
Evaluate the safety and feasibility effecting the appearance of cellulite on the thigh using CoolSculpting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects > 22 years of age and < 65 years of age.
- •Subject has clearly visible cellulite on the intended treatment area (thighs), which in the Investigator's opinion, may benefit from the treatment.
- •Subject has not had weight change exceeding 5% in the preceding month.
- •Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
- •Subject has read and signed a written informed consent form.
排除标准
- •Subject has had a surgical procedure(s) in the area of intended treatment.
- •Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
- •Subject has had a non-invasive fat reduction, body contouring, cellulite reduction and/or skin tightening procedure in the area of intended treatment within the past 4 months.
- •Presence of significant suntan in the thighs.
- •Inability to avoid sun exposure in the thighs.
- •Subject has a history of hernia in or adjacent to the areas to be treated.
- •Subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- •Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
- •Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- •Subject has a history of bleeding disorder or is taking any medication that in the Investigator's opinion may increase the subject's risk of bruising.
- •Subject has known sensitivity or allergy to isopropyl alcohol and propylene glycol.
- •Subject is taking or has taken diet pills or supplements within the past month.
- •Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites, that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
- •Subject has an active implanted device such as a pacemaker, defibrillator, implants (e.g. buttock implants), or drug delivery system.
- •Subject is pregnant or intending to become pregnant during the study period (in the next 9 months).
- •Subject is lactating or has been lactating in the past 6 months.
- •Subject is unable or unwilling to comply with the study requirements.
- •Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- •Any other condition or laboratory value that would, in the professional opinion of the Investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
结局指标
主要结局
Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel
时间窗: Week 12 post final treatment (up to 24 weeks after first treatment)
Photographs of the treatment area taken at baseline and 12-weeks after final treatment were assessed for visual changes. Reported here is the mean percentage (%) of correct baseline identification of images by the blinded independent reviewers.
次要结局
- Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)(Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment))
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by CryolipolysisAdiposityNCT01673113Massachusetts General Hospital11
已完成
不适用
CoolSculpting and RF for the SubmentalBody Fat DisorderNCT03873779Zeltiq Aesthetics8
已完成
不适用
CoolSculpting of the Distal Thigh StudyBody Fat DisorderNCT02335749Zeltiq Aesthetics40
已完成
不适用
CoolSculpting in the Abdomen Using Applicator With and Without CCIBody Fat DisorderNCT02787850Zeltiq Aesthetics20
已完成
不适用
CoolSculpting® the Upper Arms and Inner Thighs in Participants of Chinese Descent (XinCOOL)Body Fat DisorderNCT04142450Allergan50