Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Zift, LLC
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Brow Elevation
研究概览
简要总结
The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used to confirm the device safety and efficacy and provide inputs to further refine the device design and procedure technique for future device iterations
详细描述
The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used to confirm the device safety and efficacy and provide inputs to further refine the device design and procedure technique for future device iterations Subjects with signed informed consents and who meet all the inclusion and none of the exclusion criteria and are treated with the device will be considered enrolled in the study. An interim report will be created after the first 20 patients has completed their 90 follow up and the data monitored. The 20 patients, 90 day report may be submitted to FDA and other agencies for product clearance and registrations. After FDA clearance has been obtained, the study may be converted to a post-market study for the long term follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide informed consent to the treatment
- •Willing and able to participate in all the required follow-ups
- •Over 18 years of age
- •Under 75 years of age
- •Brow ptosis and/or functional limitations such as vision defects due to tissue laxity caused by aging
排除标准
- •Known allergies to local anesthesia
- •Currently undergoing chemotherapy or radiation therapy for cancer
- •Known advanced osteoporosis that may lead to skull thinning
- •Taking long-term immunosuppressant therapy
- •Taking chronic anticoagulation therapy (including ASA and NSAIDS) which can't be stopped for 10 days before treatment.
- •Unable or unwilling to participate in follow-up examinations
- •Evidence of brow soft tissue thickness less than 4mm by physical exam, ultrasound or direct probe (probe at the time of procedure)
- •Stroke or TIE (Transient Ischemic Event) within the past 6 months and currently on anti-platelet or other blood thinners
- •Chronic facial paralysis due to trauma, Bells Palsy, or similar etiology
- •Treatment with neurotoxin in the past 6 months and during the study period. Subjects may undergo a neurotoxin washout for 6 months prior to study participation
- •Planned surgical procedures, fillers or other facial procedures during the study period.
- •Planned modification of the eyebrows (to include plucking or shaving) during the study period
- •Planned MRI during the study period
- •Known nickel allergy
结局指标
主要结局
Change in Brow Elevation
时间窗: 90 days, 6 months, 1, 2, 3 and 4 years
Change in brow elevation in mm from baseline to 90 days, with long term follow-up out to 4 years
次要结局
- Patient Satisfaction(90 days, 6 months, 1, 2, 3 and 4 years)
- Physician Satisfaction(90 days, 6 months, 1, 2, 3 and 4 years)