A Post-Market Study of a Minimally Invasive Beast Lift Procedure Utilizing the Renuvion APR System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apyx Medical
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180.
研究概览
简要总结
This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System to both breasts.
详细描述
This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System to both breasts.
At baseline, the grade of breast ptosis, breast measurements and pre-surgery photographs will be taken using the site's camera system.
Procedure data and adverse events will be captured.
Follow-up visits will occur at 30, 90, and 180-days post-procedure. Subjects may also be seen back for follow-up at the investigator's discretion.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects, ages 18 - 75 years old.
- •ASA Physical Status Classification System Class I and Class II subjects.
- •Breast Ptosis Class II and Class III as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis.
- •Breast Cup Size A and Size B.
- •Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
- •Absence of physical conditions unacceptable to the investigator.
- •Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
- •Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
- •Willing to release rights for the use of study photos, including in publication.
- •Able to read, understand, sign, and date the informed consent.
- •Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.
排除标准
- •Subjects presenting with ASA Physical Status Classification System Classes III or higher.
- •Breast ptosis Class IV or more as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis.
- •Breast Cup Size C, Size D or larger.
- •Prior surgery or procedure in the breast area (i.e., implants, skin tightening procedures, breast reduction, etc.).
- •Pregnant, lactating, or plans to become pregnant during study participation.
- •Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).
- •Known hypersensitivity or allergy to ibuprofen or other NSAIDS.
- •Previous treatment in the study treatment area.
- •Active systemic or local skin disease that may alter wound healing.
- •Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
- •History of autoimmune disease (excluding Hashimoto's thyroiditis).
- •Known susceptibility to keloid formation or hypertrophic scarring.
- •Cancerous or pre-cancerous lesions in the area to be treated.
- •Possesses a surgically implanted electronic device (i.e., pacemaker).
- •Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
- •Participation in any other investigational study within 30 days prior to consent and throughout study participation.
- •Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
结局指标
主要结局
Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180.
时间窗: 180-Day
Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers.
次要结局
- Independent Photographic Review of Before and After Images Compared to Baseline at D90.(90-Day)