Measuring Renuvion Soft Tissue Contraction Using Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apyx Medical
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Analysis of Contraction From Baseline to Day 365
研究概览
简要总结
This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. All adverse events and expected treatment effects will be documented.
Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, & D365.
详细描述
This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Demographic information, medical history, and procedure details will be documented. Pre- and post-procedure care are per investigator standard of care and documented. Video may be taken during the procedure.
Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. At baseline, photographs will be taken of the treatment areas. Surface area measurements will be taken of each treatment area prior to study treatment.
Post-procedure care will be as per investigator standard of care and documented. All adverse events and expected treatment effects will be documented.
Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, & D365.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are scheduled for a procedure involving the use of Renuvion for the contraction of subcutaneous soft tissue. Patients undergoing procedures involving Renuvion alone and/or Renuvion following liposuction will be included.
- •Patients who have acceptable cardiopulmonary health for outpatient surgery.
- •Willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits.
- •Willing to release rights for the use of study photos, including in potential publication.
- •Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.
- •Able to read, understand, sign and date the informed consent document (English only).
排除标准
- •BMI of greater than
- •Diabetes mellitus with A1C score >
- •Active cigarette smokers or nicotine vape users.
- •History of connective tissue disease (Ehlers Danlos, Cutis Laxa, Pseudoxanthoma Elasticum, Marfan's, etc.)
- •Patients who, in the opinion of the investigator, is not an appropriate candidate for the study.
- •Patients requiring a concomitant procedure in the Renuvion treatment area that could impact the ultrasound measurements or the effectiveness results.
结局指标
主要结局
Analysis of Contraction From Baseline to Day 365
时间窗: Baseline, Day 365
Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images to quantify the total amount of connective tissue contraction produced by the Renuvion treatment between the skin and the Scarpa's fascia. A negative value indicates greater tissue contraction, while a positive value indicates less tissue contraction.
次要结局
- IPR Review(Day 365)
- Physician Global Aesthetic Improvement(Day 60, Day 90, Day 180, Day 270, Day 365)
- Subject Global Aesthetic Improvement(Day 60, Day 90, Day 180, Day 270, Day 365)
- Patient Satisfaction(Day 180, Day 270, Day 365)
- Energy Delivered(Day 0)