Prospective Study on Fat Retention When Using the AuraGen 1-2-3™ With AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 27
- 主要终点
- Patient Satisfaction
研究概览
简要总结
Prospective, multi-center, non-randomized, open-label, post-market clinical study evaluating adipose graft retention over time from lipoaspirate processed using the AuraGen 1-2-3™ with AuraClens™ Lipoaspirate Wash System.
详细描述
Autologous fat transfer (AFT) is a medical procedure that includes aspirating adipose tissue from one part of the body, and washing, filtering and re-injecting the processed fat tissue into a different part of the body with the primary purpose of adding volume. The AuraGen1-2-3 with AuraClens Lipoaspirate Wash System is designed to be used in the operating room in conjunction with a user-provided liposuction cannular, a vacuum source, and waste canister. The study population will consist of up to 200 subjects in (2) cohorts: 100 subjects undergoing breast reconstruction and 100 subjects undergoing breast augmentation. All subjects will receive autologous lipoaspirate processed with the A123+ AuraClens and will be followed post-procedure at 1-, 3-, 6-, and 12-months. Fat graft retention will be evaluated with 3D imaging using the Canfield Vectra XT imaging system. Patient satisfaction will be measured between baseline and the post-procedure follow-up visits using a breast satisfaction questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Augmentation Subjects
- •Inclusion Criteria:
- •Female patients > 22 years and < 65 years of age.
- •Patients with a BMI <
- •Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) with or 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 200 and 700 cc.
- •Anticipated fat injection volume between 50 and 350 cc per breast.
- •Anticipated breast implant volume between 200 and 550 cc.
- •Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in 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 history of trauma or surgery to the treatment area.
- •Patients with history of breast cancer.
- •Active, chronic, or recurrent infection.
- •Compromised immune system.
- •Hypersensitivity to analgesic agents.
- •Co-morbid condition that could limit 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 contra-indicate the patient's participation.
- •Patients who do not wish to have the study area (breast) photographed.
- •Reconstruction Subjects
- •Inclusion Criteria:
- •Female patients > 18 years and < 65 years of age.
- •Patients with a BMI <
- •Patients undergoing a fat grafting procedure to the breast in a second or third stage of a staged breast reconstruction, with or without a breast implant.
- •Patient is at least 1 year post-completion of chemotherapy.
- •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 200 and 700 cc.
- •Anticipated fat injection volume between 50 nd 350cc per breast.
- •Anticipated breast implant volume (if applicable) between 200 and 550 cc.
- •Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study.
- •Exclusion Criteria:
- •Skin rash in the treatment area.
- •Patients who smoke or use nicotine products.
- •Patients with bleeding disorders or currently taking anticoagulants.
- •Patients undergoing active treatment for breast cancer.
- •Active, chronic, or recurrent infection.
- •Compromised immune system.
- •Hypersensitivity to analgesic agents.
- •Co-morbid condition that could limit 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 contra-indicate the patient's participation.
- •Patients who do not wish to have the study area (breast) photographed.
研究组 & 干预措施
Augmentation
Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.
干预措施: AuraGen 1-2-3 with AuraClens (Device)
Reconstruction
Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.
干预措施: AuraGen 1-2-3 with AuraClens (Device)
结局指标
主要结局
Patient Satisfaction
时间窗: 1 Year
Confidence/Satisfaction
Fat Grafting Volume Retention
时间窗: 1 Year
Fat grafting volume retention from procedure to 12-months.
次要结局
未报告次要终点