Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure

Study Overview
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Brief Summary
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The intended purpose of the MyEllevate® procedure used in this study is to assess the safety and efficacy of the procedure for soft tissue approximation and elevation of sub dermis and underlying muscle of the submentum & jawline.

Detailed Description
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Subjects are to be enrolled in this clinical study if they are a healthy male or female between the age of 18 - 65. Up to 10 subjects will be enrolled at 2 study centers. All subjects will attend a screening/pre-procedure visit which may be performed on the same day as the procedure visit but no more than 30 days prior to their procedure.

Official Title
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Prospective Clinical Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure

Conditions
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Soft Tissue Approximation, Elevation of Subdermis, Elevation of Underlying Muscle

Intervention / Treatment
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* Device: MyEllevate Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy male or female between the age of 18 - 65. Must have any or all the following: visible platysma bands, glands and/or sagging in the submentum, jawline and/or neck. Reads and understands English. Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study. Understands and accepts the obligation and is logistically able to be present for all visits. Is willing to comply with all requirements of the study and sign the informed consent document. Exclusion Criteria: Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study. Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study. Have received any treatments or procedures (including injectables such as Botox or fillers) in the area to be treated at least 4 months prior to treatment. Take antiplatelets, anticoagulants, thrombolytics, or anti-inflammatories. Have an active localized or systemic infection. Have an open wound in area being treated. Have a significant systemic illness or an illness localized in area being treated. Have had recent surgeries or problems in the treatment area (e.g. neck fracture, neck sprain, pinched nerve, spondylosis, arthritis in the neck). Have a history of thrombophlebitis. Have a history of heart failure or kidney disease. Have a history of allergic reaction or intolerance to the anesthesia used during the procedure. Have a history of poor wound healing. Have a history of poor circulation. Have a systemic autoimmune disease known to impair wound healing. Have a history of keloid formation. Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study. Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment for MyEllevate Procedure<br>The subjects were treated with the MyEllevate procedure. | Device: MyEllevate Procedure<br>* The defined study area will be identified and may be marked with a surgical marker. A local tumescent anesthetic, such as lidocaine, will be injected to the area prior to the procedure. The MyEllevate® device will be used in accordance with the Instructions for Use (IFU) manual for soft tissue approximation and elevation of sub dermis and underlying muscle of the submentum and jawline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Photos Taken Pre-Treatment vs. at Follow Up Correctly Identified | Blinded reviewers will examine pre-treatment and follow up images to determine which photograph was taken before the treatment started and which photograph was taken at the follow up visit. The percent of photographs that were correctly identified as being post-treatment photographs will be reported. | 30 days post last treatment | 
| Percent of Photos Taken Pre-Treatment vs. at Follow Up Correctly Identified | Blinded reviewers will examine pre-treatment and follow up images to determine which photograph was taken before the treatment started and which photograph was taken at the follow up visit. The percent of photographs that were correctly identified as being post-treatment photographs will be reported. | 90 days post last treatment |