Prospective Comparison of the Revolve™ and AuraGen 1-2-3™ With AuraClens™ Systems in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Fat volume retention at 6 months post-op
研究概览
简要总结
The purpose of this study is to compare fat graft retention over time from lipoaspirate processed using two FDA-cleared devices: the Revolve System (K120902) and the AuraGen 1-2-3 with AuraClens Lipoaspirate Wash System (BK190433).
详细描述
This is a single-center, prospective, randomized study enrolling patients undergoing an aesthetic fat grafting procedure to the breast without a breast implant. A total of 20 patients will be enrolled in the study. Ten patients will receive lipoaspirate processed with the Revolve and ten patients will have lipoaspirate processed with the AuraGen 1-2-3 with AuraClens.
Patients will be followed on post-procedure months 3, 6, and 12. Fat graft retention will be evaluated by photographic assessment by blinded reviewers, and 3D imaging. Patient satisfaction will be measured using the Breast-Q - Augmentation survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients > 18 years and < 65 years of age
- •Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) without a breast implant.
- •Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
- •Patients must be non-smokers.
- •Patients with available/adequate harvest sites for fat grafting.
- •Anticipated harvested fat volume between 400 and 1400 cc
- •Anticipated fat injection volume 150-350 cc per breast
- •Patients must agree to maintain their weight (i.e. within 5%) by not making any major changes in their diet or lifestyle during the study.
排除标准
- •Skin rash in the treatment area.
- •Patients who smoke or use nicotine products.
- •Patients with bleeding disorders or currently taking anticoagulants.
- •Patients with a history of trauma or surgery to the treatment area.
- •Patients with a history of breast cancer.
- •Active, chronic, or recurrent infection.
- •Compromised immune system (e.g. diabetes).
- •Hypersensitivity to analgesic agents.
- •Co-morbid conditions that could limit their ability to participate in the study or to comply with follow-up requirements.
- •Untreated drug and/or alcohol abuse.
- •Pregnant or breastfeeding.
- •Any issue that, at the discretion of the investigator, would contraindicate the patient's participation.
- •Patients who do not wish to have the study area (breast) photographed
- •NOTE Please note that there is no remuneration for participation in this study.
结局指标
主要结局
Fat volume retention at 6 months post-op
时间窗: 6 months post-op
Measurement of volume of fat graft at 6 months post-op, using 3D photography
Fat volume retention at 3 months post-op
时间窗: 3 months post-op
Measurement of volume of fat graft at 3 months post-op, using 3D photography
Fat volume retention at 12 months post-op
时间窗: 12 months post-op
Measurement of volume of fat graft at 6 months post-op, using 3D photography
次要结局
- Patient Satisfaction(12 months post-op)