Clinical trial NCT03055819: Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study
Official title: Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Senile Ptosis
Keywords: Brow Lift
Brow Ptosis
Lead sponsor: Zift, LLC
Sponsor class: INDUSTRY
Collaborators: name: Libra Medical
First posted: 2017-02-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, open label, multi-center
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Brow Elevation
timeFrame: 90 days, 6 months, 1, 2, 3 and 4 years
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 90 days, 6 months, 1, 2, 3 and 4 years
measure: Physician Satisfaction
timeFrame: 90 days, 6 months, 1, 2, 3 and 4 years
Other outcomes:
Locations:
city: Edina
country: United States
facility: Centennial Lakes Surgery Center
state: Minnesota
Study officials:
affiliation: Centennial Lakes Surgery Center
name: Peter A Hilger, MD
role: PRINCIPAL_INVESTIGATOR
References: