NCT01100190终止不适用
A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- Composite incidence of adverse device events
研究概览
简要总结
The objective of this study is to evaluate the clinical tolerability of the NUVANCE™ Facial Rejuvenation System for correcting neck, mid-face and/or jowl ptosis.
详细描述
This is a multicenter, prospective, single-arm study. The primary tolerability endpoint will be evaluated up to 30-days post-operatively. Secondary endpoints will be evaluated at 6-months. Extended follow-up will be conducted at 12-months, 24-months, and 36-months.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject older than 18 years.
- •Subject is a candidate for minimally invasive, bilateral facial rejuvenation procedure using NUVANCETM Facial Rejuvenation System according to the device Instructions for Use (IFU).
- •Subject is willing and able to provide informed consent and follow study-related requirements.
排除标准
- •Subject who previously received surgical facial cosmetic treatment (procedure involving an incision):
- •Within the last 12 months under the area of the forehead;
- •Within the last 3 months within the area of the forehead where forehead is defined as the area above the imaginary anatomical line between the lateral canthus of the eye and the upper pole of the ear.
- •Subject who previously received a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within the last 9 months.
- •Subjects with a permanent facial implant.
- •Subjects planning on a cosmetic procedure with a permanent implant within 6-months of procedure.
- •Subjects planning on a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within 6-months of procedure.
- •Subjects with significant ptosis where skin excision would be necessary.
- •Subject has an active infection (e.g. acne, herpes zoster) or inflammation (e.g. psoriasis, pemphigus vulgaris, cutaneous lupus erythematosus) affecting facial skin.
- •Subject has a history of a disorder that can affect wound healing (e.g. subjects pre-disposed to infection or history of keloid formation).
- •Subject with pre-existing facial abnormalities (e.g. deformities, Bell's palsy, scarring)
- •Subject with a significant psychiatric disorder judged by the clinical investigator that will interfere with the procedure
- •Any pre-operative findings that the surgeon identifies that makes the subject not a candidate for a minimally invasive facial cosmetic surgical procedure.
研究组 & 干预措施
NUVANCE Facial Rejuvenation System
Experimental
干预措施: NUVANCE Facial Rejuvenation System (Device)
结局指标
主要结局
Composite incidence of adverse device events
时间窗: up to 30-days post-procedure
The primary tolerability endpoint includes sensory nerve injury, skin necrosis, wound dehiscence, hypertrophic scarring, alopecia, surgical site infection, earlobe deformity, submental irregularity, hematomas, perforation, and palpability.
次要结局
- Individual incidence of adverse device events(up to 3 yrs post-op)
- Incidence of treatment failures and cosmetic re-intervention(up to 3 yrs post-op)
- Global Improvement Assessment using standardized photographic images(up to 3 yrs post-op)
- Quality of Life changes prior to and after surgery(up to 3 yrs post-op)
研究者
研究点 (18)
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