Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Abdominal Circumference
研究概览
简要总结
The octipolar applicator is intended for circumference reduction treatment by reduction of adipose size and enhancement of collagen synthesis as the result thermal and non-thermal collagen stimulation. This trial is intended to evaluate the effect of radio frequency (RF) and pulsed electromagnetic fields (PEMF) treatment on circumference reduction.
详细描述
This is a multi-site, prospective, controlled, randomized, double blinded clinical trial. This study is designed to evaluate the safety and efficacy of a series of treatments using the Venus Versa Octipolar applicator. Up to 60 healthy subjects at 10 sites shall be recruited by the investigator from within the investigator's subject population. Subjects shall have abdomen circumference to reduce for the designated treatment area.
Each subject will undergo 6 treatments at an interval of one treatment per week for six consecutive weeks. There will be a one month follow up which will occur 4 weeks after the 6th treatment.
At the first treatment visit, the investigator will collect demographic and medical information and randomization will take place. Subjects have an equal opportunity to be selected for the treatment or the control group.
The duration of the treatment session will be approximately 60 minutes. Expected immediate response includes temporary mild to moderate erythema and/or edema. Skin safety assessments will be conducted by the investigator after each treatment session and at the follow-up visit.
Photography will be conducted at baseline, the beginning of 4th & 6th treatment and at 1 month follow up visit. Subjects will be asked to complete a questionnaire after each treatment and at the one month follow up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) score is greater than 18.5 and less than 29.9 - normal to overweight, but not obese.
- •Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.
- •For female of child bearing potential - using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, Intra Uterine Device (IUD), contraceptive implant, barrier methods with spermicide, or abstinence).
排除标准
- •Pregnant or planning to become pregnant, having given birth less than 9 months ago, and/or breastfeeding.
- •Having any active electrical implant anywhere in the body,
- •Having a permanent implant in the treated areas
- •Having received treatment with laser, RF or other devices in the treated areas within 6 months of treatment or during the study.
- •Having undergone a liposuction surgery or any contouring treatment in the areas intended for treatment within 2 years of treatment
- •Having or undergoing any form of cancer
- •Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders.
- •Having a anticoagulative or thromboembolic condition or taking anticoagulation medications
- •History of immunosuppression/immune deficiency disorders
- •Suffering from hormonal imbalance which may affect weight or cellulite
- •History of significant lymphatic drainage problems.
- •History of keloid scarring or of abnormal wound healing.
- •History of being especially prone to bruising.
- •History of epidermal or dermal disorders
- •Use of isotretinoin within 6 months
- •Significant change in diet or exercise regimen within a month of enrollment or during this study and/or weight loss or gain of 10 lbs (4.5 kgs) within 2 months of enrollment or during this study.
- •Participation in a study of another device or drug within 1 month prior to enrollment or during this study.
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
研究组 & 干预措施
Control Group
Group treated with the inactive Venus Versa octipolar applicator and the glycerine gel.
干预措施: Glycerine gel (Other)
Treatment Group
Group treated with the active Venus Versa octipolar applicator and the glycerine gel.
干预措施: Venus Versa (Device)
Treatment Group
Group treated with the active Venus Versa octipolar applicator and the glycerine gel.
干预措施: Glycerine gel (Other)
Control Group
Group treated with the inactive Venus Versa octipolar applicator and the glycerine gel.
干预措施: Venus Versa (Device)
结局指标
主要结局
Abdominal Circumference
时间窗: 1 month post treatment series
Abdominal circumference measurement of the treated area at 1 month after the last treatment performed by controlled tape measurement
次要结局
- Subject Satisfaction With Treatment(1 month post treatment series)