Pilot Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects > 18 years of age and < 65 years of age.
- •Presence of submental fat, which in the investigator's opinion, may benefit from the treatment.
- •No weight change exceeding 10 pounds in the preceding month.
- •Agreement to maintain his/her weight (i.e., within 10 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
- •Subject has signed a written informed consent form.
排除标准
- •Skin laxity in the neck or chin area for which reduction in submental fat may.
- •Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.
- •Enlargement on the anterior neck that may prevent the proper placement of the applicator.
- •Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area.
- •Botulinum toxin injections within the neck or chin area.
- •History of a fat reduction procedure in the area of intended treatment.
- •History of prior surgery in the area of intended treatment.
- •Current dental infection.
- •Known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- •Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- •Impaired skin sensation or thermal sensitivity in the intended treatment area.
- •Open or infected wounds in the intended treatment area.
- •Currently taking or has taken diet pills or weight control supplements within the past month.
- •Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
- •Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
- •Pregnant or intending to become pregnant in the next 5 months.
- •Lactating or has been lactating in the past 6 months.
- •Unable or unwilling to comply with the study requirements.
- •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
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
时间窗: 8-weeks post treatment
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.
次要结局
- Change in the Fat Layer of the Treated Area as Measured by Ultrasound(Baseline, 8-weeks post treatment)
- Number of Pre- and Post-Treatment Photograph Pair Reviews (Correctly Identified by an Internal Reviewer Panel of 4 Reviewers)(8-weeks post treatment)