Feasibility Study of a Belt Applicator
2020年10月1日 更新者：Zeltiq Aesthetics
Feasibility Study of a Belt Applicator for Non-Invasive Fat Reduction in the Outer Thigh
Evaluate the safety and feasibility of non-invasive fat reduction in the outer thigh with a belt applicator.
Applicator design and treatment parameters will be evaluated.
研究概览
详细说明
The Zeltiq CoolSculpting System technology for cold-assisted lipolysis will be used with a modified belt applicator for the reduction of fat on the outer thigh.
This is an open label, interventional, non-randomized feasibility study.
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Marina Del Rey、California、美国、90292
- Marina Plastic Surgery
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Pleasanton、California、美国、94588
- Innovation Research Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria
- Male or female subjects > 18 years of age and < 65 years of age.
- Subject has clearly visible fat on intended treatment area (outer thighs), which in the investigator's opinion, may benefit from the treatment(s).
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in his/her diet or lifestyle during the course of the study.
- Subject has read and signed a written informed consent form.
Exclusion Criteria
- 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 and/or body contouring procedure in the area of intended treatment within the past 6 months.
- 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, 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 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, or drug delivery system
- Subject is pregnant or intending to become pregnant in the next 8 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Outer Thigh CoolSculpting Treatment
Treatment with the CoolSculpting System and a modified belt applicator will be performed on one outer thigh; the remaining thigh is considered the untreated control.
Subjects will receive one cooling cycle applied to the thigh area intended for treatment with a protocol-defined cooling rate and duration of 120 minutes.
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Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh
大体时间：Baseline to 16 weeks post-final treatment
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For each subject, ultrasound measurements will be obtained from the treated area and the contralateral untreated control area.
The change in fat layer thickness in the untreated control thigh between baseline and 16 weeks will be used to account for variation in subject body weight during the study.
The fat layer thickness change in the treated area will be normalized by subtracting the change in the untreated control thigh to remove the influence of subject weight variations.
The normalized value will be used to evaluate success.
The result is considered the treatment effect, an absolute change, and is reported as a mean change for the study population in centimeters of fat layer reduction.
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Baseline to 16 weeks post-final treatment
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Safety of the Zeltiq System and Procedure
大体时间：Study enrollment through 16 weeks post-treatment
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The number of device- and/or procedure related adverse events will be tabulated.
Adverse event reports are collected throughout the study from the time of enrollment through the final 16 week follow-up visit.
Investigators will determine whether an adverse event has a relationship to the study device or procedure.
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Study enrollment through 16 weeks post-treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percent of Correct Identification of Pre-treatment Photos
大体时间：Baseline and 16 weeks post-final treatment
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Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas.
Reviewers will be practicing dermatologists or plastic surgeons.
All reviewers will be blinded to post-treatment vs. baseline untreated area.
The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images.
Reviewers will be asked to select the baseline (pre-treatment) photos for each subject photo series and record selections on a data collection form.
Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure.
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Baseline and 16 weeks post-final treatment
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Percentage of Participants With Satisfaction on Questionnaire Questions
大体时间：16 weeks post-treatment
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Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.
The questionnaire was composed of 5-point Likert scale questions, as well as free text responses.
Each question offered five choices, ranging from very favorable, somewhat favorable, neutral/not sure, unfavorable and very unfavorable responses.
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16 weeks post-treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Eric Bachelor, MD、Innovation Research Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年1月1日
初级完成 (实际的)
2014年10月1日
研究完成 (实际的)
2014年10月1日
研究注册日期
首次提交
2013年1月9日
首先提交符合 QC 标准的
2013年1月11日
首次发布 (估计)
2013年1月14日
研究记录更新
最后更新发布 (实际的)
2020年10月26日
上次提交的符合 QC 标准的更新
2020年10月1日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.