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

Senile Ptosis Clinical Trial

— LIFT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03055819
• Other study ID #: 1068-001Rev3
• Status: Terminated
• Phase: N/A
• Start date: February 3, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: August 2023
• Source: Zift, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 31, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Senile Ptosis

Intervention

Device:
• Brow Lift
Minimally Invasive Brow Lift

Locations

Country	Name	City	State
United States	Centennial Lakes Surgery Center	Edina	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Zift, LLC	Libra Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Satisfaction	Patient Satisfaction using the Face-Q survey	90 days, 6 months, 1, 2, 3 and 4 years
Secondary	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