Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study

Conditions
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Senile Ptosis

Intervention / Treatment
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* Device: Brow Lift


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm, open label, multi-center
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZiftLift Tissue Anchor<br>Use of ZiftLift Tissue Anchors for Brow Lift | Device: Brow Lift<br>* Minimally Invasive Brow Lift<br>* Other names: Brow Pexy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brow Elevation | Change in brow elevation in mm from baseline to 90 days, with long term follow-up out to 4 years | 90 days, 6 months, 1, 2, 3 and 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Patient Satisfaction using the Face-Q survey | 90 days, 6 months, 1, 2, 3 and 4 years | 
| Physician Satisfaction | Physician Satisfaction with Cosmetic Result. 7 metrics on all patients at all time points using a survey tool. | 90 days, 6 months, 1, 2, 3 and 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brow Lift, Brow Ptosis