Exploratory Evaluation of the Lutronic Genius System for Treatment of the Neck
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Masked qualitative assessment of improvement
研究概览
简要总结
The Genius system is substantially equivalent to the Infini device (K121481). The study is a prospective, multi-site, non-randomized study of up to 30 treated subjects presenting for treatment of mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.
详细描述
At enrollment, standardized baseline/pretreatment 2D and 3D images will be obtained from each subject. Study subjects will receive three neck treatments completed 30 days apart. Subjects will be contacted via a phone call 3 days following each treatment to assess for adverse events and expected treatment effects. Effectiveness assessments will occur prior to Treatments #2 and #3, and a follow-up visit will be completed at 90 days following Treatment #3. Each assessment visit will include efficacy, adverse events, and expected treatment effects assessments, and post-treatment 2D and 3D digital images will be captured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age 18 years and older.
- •Subject in good health.
- •Fitzpatrick Skin Type I to VI.
- •Mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- •Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- •Post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.
- •Absence of physical or psychological conditions unacceptable to the investigator.
- •Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
- •Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
排除标准
- •Presence of an active skin condition or infection in the treatment area such as sores, Psoriasis, eczema, rash, severe active inflammatory acne or oral herpes simplex breakout.
- •History of skin disorders, keloid scarring, and/or abnormal wound healing.
- •Open wounds or lesions in the area(s) to be treated.
- •Inability to understand the protocol or to give informed consent.
- •History of chronic drug or alcohol abuse.
- •History of vascular disease.
- •History of bleeding disorders.
- •BMI equal to or greater than
- •Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the trial.
- •Subjects with current skin cancer or other malignant disease including pre-malignant moles.
- •Poorly controlled medical condition that could compromise wound healing or increase risk of infection such as an impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications, radiation therapy, or chemotherapy.
- •Subjects with implanted medical devices: pacemaker, cardioverts, superficial metal within the treatment area, and other implantable devices or synthetic fillers.
- •Subjects with sensitivity or allergy to gold.
- •Subjects with sensitivity or allergy to local anesthetics such as lidocaine or tetracaine.
- •Concurrent enrollment in any study involving the use of investigational devices or drugs.
- •History of surgical or cosmetic treatments in the area(s) to be treated within the past six months.
- •History or current use of the following prescription medications:
- •Daily anticoagulants, aspirin, iron supplements, herbal supplements such as ginkgo, ginseng or garlic within the past two weeks;
- •Topical retinoid within the past one week; and
- •Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
结局指标
主要结局
Masked qualitative assessment of improvement
时间窗: From baseline to 90 days following the last treatment
An assessment of paired pre- and post-treatment photographs will be conducted by blinded assessors evaluating for improvement in neck appearance from pre- to post-treatment. The assessors choose the photo they believe to be the post-treatment photo, i.e., Left photo or Right photo.
次要结局
- Subject aesthetic improvement(From baseline to Days 90 following the last study treatment.)
- Clinician aesthetic improvement(From baseline to Days 90 following the last study treatment.)
- Patient Satisfaction(From baseline to 90 days following the last study treatment)
- Treatment-related pain(For the duration of each study treatment which typically can last up to approximately 90 minutes.)