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

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

Study Overview

• Status: Terminated
• Conditions: Senile Ptosis
• Intervention / Treatment: Device: Brow Lift

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Centennial Lakes Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZiftLift Tissue Anchor; Use of ZiftLift Tissue Anchors for Brow Lift	Device: Brow Lift; Minimally Invasive Brow Lift; Other Names: Brow Pexy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zift, LLC
• Collaborators: Libra Medical
• Investigators: Principal Investigator: Peter A Hilger, MD, Centennial Lakes Surgery Center

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2017
• Primary Completion (Actual): April 2, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Brow Lift; Brow Ptosis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 1068-001Rev3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes