Evaluation of Patient and Physician Satisfaction With the... | NCT03055819

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

NCT03055819

Sponsor

Zift, LLC

Status

Terminated

Last Update Posted

Aug 7, 2023Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Senile Ptosis

Interventions

Brow Lift

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company no longer exists

Expanded Access Info

Start Date

Feb 3, 2017Actual

Primary Completion Date

Apr 2, 2018Actual

Completion Date

Oct 31, 2018Actual

First Submitted Date

Feb 14, 2017

First Submission Date that Met QC Criteria

Feb 14, 2017

First Posted Date

Feb 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2023

Last Update Posted Date

Aug 7, 2023Actual

Name	Class
Libra Medical	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ZiftLift Tissue Anchor	Experimental	Use of ZiftLift Tissue Anchors for Brow Lift	Device: Brow Lift

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brow Lift	Device	Minimally Invasive Brow Lift	ZiftLift Tissue Anchor

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Peter A Hilger, MD	Centennial Lakes Surgery Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Centennial Lakes Surgery Center		Edina	Minnesota	55435	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided