A Post-Market Study In Greece Of A Minimally Invasive Lower Eyelid Treatment Utilizing The Renuvion System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apyx Medical
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
研究概览
简要总结
This is a prospective, multi-center, non-randomized, single-arm study of up to 15 subjects treated with the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System in the lower periorbital area on both sides of the face.
详细描述
This is a prospective, multi-center, non-randomized, single-arm study of up to 15 subjects treated with the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System in the lower periorbital area on both sides of the face.
At baseline, images will be taken utilizing the site's camera system. Baseline images will be used as comparator images for follow-up images for Independent Photographic Reviewer evaluation and subject/investigator assessments.
The treatment area will be tumesced with 20 - 25ml of fluid on each side of the periorbital area.
The treatment of the periorbital area will be accessed from an incision placed in the crease of the lower lid. Two incisions will be placed in both the medial and lateral crease of the lower lid. Treatment will be performed through one incision and the second incision will be used to allow for adequate venting of helium gas. Care will be taken to undermine the tissue and to ensure the incisions communicate with each other to allow adequate venting. An optional third lower lid incision may be made as needed. The treatment plane will be above the orbicularis muscle. The treatment settings will be 20% Power, 1 LPM, and 3 Passes. Procedure data and adverse events will be captured.
Follow-up will occur 1 day, 3 days, 7 days, 30 days, 90 days, and 180 days post-procedure; images will be taken at all visits. Investigator/subjects assessments will be completed at D30, D90, and D180 visits. 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
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects, ages 18 - 75 years old.
- •ASA Physical Status Classification System Class I and Class II subjects.
- •Complaint of skin laxity or lines in the lower eyelid area.
- •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.
- •Festoons in the periorbital area.
- •Prior cosmetic/aesthetic fillers (hyaluronic acid, poly-l-lactic acid, calcium hydroxylapatite, et.) in the study treatment area within the past 12 months.
- •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 surgery 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
Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
时间窗: 180-Day
Improvement in the lower eyelid area as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers. Improvement will be assessed based on photographs taken at all visits using the site's 2D camera system.
次要结局
- Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.(90-Day)