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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055819
Recruitment Status : Active, not recruiting
First Posted : February 16, 2017
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
Libra Medical
Information provided by (Responsible Party):
Zift, LLC

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

Condition or disease Intervention/treatment Phase
Senile Ptosis Device: Brow Lift Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open label, multi-center
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study
Actual Study Start Date : February 3, 2017
Actual Primary Completion Date : April 2, 2018
Estimated Study Completion Date : April 1, 2021

Arm Intervention/treatment
Experimental: ZiftLift Tissue Anchor
Use of ZiftLift Tissue Anchors for Brow Lift
Device: Brow Lift
Minimally Invasive Brow Lift
Other Name: Brow Pexy




Primary Outcome Measures :
  1. Change in Brow Elevation [ Time Frame: 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 Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 90 days, 6 months, 1, 2, 3 and 4 years ]
    Patient Satisfaction using the Face-Q survey

  2. Physician Satisfaction [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055819


Locations
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United States, Minnesota
Centennial Lakes Surgery Center
Edina, Minnesota, United States, 55435
Sponsors and Collaborators
Zift, LLC
Libra Medical
Investigators
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Principal Investigator: Peter A Hilger, MD Centennial Lakes Surgery Center
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Responsible Party: Zift, LLC
ClinicalTrials.gov Identifier: NCT03055819    
Other Study ID Numbers: 1068-001Rev3
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Zift, LLC:
Brow Lift
Brow Ptosis
Additional relevant MeSH terms:
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Prolapse
Pathological Conditions, Anatomical