Senile Ptosis
Conditions
Keywords
Brow Lift, Brow Ptosis
Brief summary
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
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.
Interventions
DEVICEBrow Lift
Minimally Invasive Brow Lift
Sponsors
Libra Medical
Zift, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Single arm, open label, multi-center
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able to provide informed consent to the treatment 2. Willing and able to participate in all the required follow-ups 3. Over 18 years of age 4. Under 75 years of age 5. Brow ptosis and/or functional limitations such as vision defects due to tissue laxity caused by aging
Exclusion criteria
1. Known allergies to local anesthesia 2. Currently undergoing chemotherapy or radiation therapy for cancer 3. Known advanced osteoporosis that may lead to skull thinning 4. Taking long-term immunosuppressant therapy 5. Taking chronic anticoagulation therapy (including ASA and NSAIDS) which can't be stopped for 10 days before treatment. 6. Unable or unwilling to participate in follow-up examinations 7. Evidence of brow soft tissue thickness less than 4mm by physical exam, ultrasound or direct probe (probe at the time of procedure) 8. Stroke or TIE (Transient Ischemic Event) within the past 6 months and currently on anti-platelet or other blood thinners 9. Chronic facial paralysis due to trauma, Bells Palsy, or similar etiology 10. 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 11. Planned surgical procedures, fillers or other facial procedures during the study period. 12. Planned modification of the eyebrows (to include plucking or shaving) during the study period 13. Planned MRI during the study period 14. Known nickel allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brow Elevation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 90 days, 6 months, 1, 2, 3 and 4 years | Patient Satisfaction using the Face-Q survey |
| Physician Satisfaction | 90 days, 6 months, 1, 2, 3 and 4 years | Physician Satisfaction with Cosmetic Result. 7 metrics on all patients at all time points using a survey tool. |
Countries
United States
Outcome results
None listed