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

NCT03055819 | Terminated FDA Device

• 1 other identifier: 1068-001Rev3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Senile Ptosis

Keywords

Brow Lift; Brow Ptosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Satisfaction

  90 days, 6 months, 1, 2, 3 and 4 years

• Physician Satisfaction

  90 days, 6 months, 1, 2, 3 and 4 years

Study Arms (1)

ZiftLift Tissue Anchor

EXPERIMENTAL

Use of ZiftLift Tissue Anchors for Brow Lift

Device: Brow Lift

Interventions

Brow Lift DEVICE

Minimally Invasive Brow Lift

Also known as: Brow Pexy

ZiftLift Tissue Anchor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zift, LLC: lead
• Libra Medical: collaborator

Study Sites (1)

Centennial Lakes Surgery Center

Edina, Minnesota, 55435, United States

Location

Study Officials

• Peter A Hilger, MD

  Centennial Lakes Surgery Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, open label, multi-center

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: February 3, 2017
• Primary Completion: April 2, 2018
• Study Completion: October 31, 2018
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)