NCT05522426尚未招募不适用
Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Facial Fat Grafting
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- FaceQ Satisfaction surveys
研究概览
简要总结
This is an open label multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in facial aesthetics and contouring. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged of 18-70 years old
- •Willing and able to read and sign the informed consent and other study materials
- •Written informed consent has been obtained prior to any study-related procedures
- •Subjects are ambulatory
- •Ability to follow study instructions and complete study assessment tools including the subject diary
- •Females of childbearing potential must have a negative urine pregnancy test result and not be lactating
- •Agree to not undergo other treatments or cosmetic procedures in the treatment area during the study such as facial laser treatments, botulinum toxin, hyaluronic acid injections, any other permanent or semi-permanent facial fillers
排除标准
- •Subjects without decisional capacity
- •Subjects unable to give informed, written consent
- •Subjects with active infection (redness, swelling, pain, suppuration)
- •Subjects with any uncontrolled systemic disease
- •Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies
- •Subjects with conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma
- •Subjects planning to become pregnant, are pregnant, or are breast-feeding
- •Subjects with history or current evidence of drug or alcohol abuse within 12 months prior to screening visit
- •Subjects who have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months in the treatment area. Have had neuromodulator injections, mesotherapy, or resurfacing (laser or other ablative or non-ablative procedures) within 5 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study.
- •Subjects who have undergone facial plastic surgery (except for rhinoplasty or a brow lift), tissue grafting, or tissue augmentation with silicone, fat, or other permanent or semi-permanent dermal fillers or be planning to undergo any of these procedures affecting the treatment area, at any time during the study that may interfere with the study procedure and results
- •Subjects who have active autoimmune disease
- •Subjects who are unwilling to undergo fat graft injections
- •Subjects with current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
- •Subjects who have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 10 days pre- to 3 days post injection. A wash out period of 10 days is allowed
- •Subjects who have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.
研究组 & 干预措施
SyntrFuge System
Experimental
Adipose tissue microsized via the SyntrFuge System
干预措施: SyntrFuge System (Device)
结局指标
主要结局
FaceQ Satisfaction surveys
时间窗: 6 months
Change from baseline in FACE-Q Satisfaction with questionnaire score for the treated regions
次要结局
- Investigator's Satisfaction Scale(6 months)
- Global Aesthetic Improvement Scale (GAIS)(6 months)
研究者
研究点 (4)
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