Pilot Study Comparing the Effectiveness of a Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device for Fat Reduction: A Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 12
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of the Zeltiq System and LipoSonix System for fat reduction and improving body shape.
详细描述
At baseline visit, subjects who meet inclusion and exclusion criteria will be enrolled. Subjects will be randomly assigned to receive Zeltiq treatment to either their right or left flank The contralateral flank will receive Liposonix treatment. A total of three identical treatments will be completed monthly for 3 consecutive months. Subjects will return 4 weeks following the last treatment for follow up photography, measurements, and assessments. This study is a pilot study designed to determine feasibility of these procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects ages 30-65 years old.
- •Body mass index (BMI) between 18 and 29.
- •(BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches).
- •Subjects are in good health.
- •Willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
- •Subjects agree to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study.
- •The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
排除标准
- •Pregnant or lactating or intends to become pregnant in the next 9 months.
- •Unable to understand the protocol or to give informed consent.
- •Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area.
- •Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment or who has taken diet pills within the last 6 months..
- •History of asthma or chronic obstructive pulmonary diseases.
- •Active skin disease or skin infection in the treatment area.
- •Bleeding tendency or coagulopathy.
- •Subjects who are allergic to lidocaine.
- •Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.
研究组 & 干预措施
Noninvasive Cryolipolysis Device
The Zeltiq System is a noninvasive (not breaking the skin) device that reduces fat by freezing fat cells until they break apart.
干预措施: Noninvasive Cryolipolysis Device (Device)
High Intensity Focused Ultrasound Device
The LipoSonix System is a noninvasive ultrasound device, which can be used to selectively target and destroy fat tissue located deep under the skin.
干预措施: High Intensity Focused Ultrasound Device (Device)
结局指标
主要结局
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 12
时间窗: 1 hour at baseline and week 12
The primary outcome was a blinded rating of the treatment area (Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device) with the best cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 12).
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation
Northwestern University