Elevation of Subdermis, Elevation of Underlying Muscle, Soft Tissue Approximation
Conditions
Brief summary
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
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.
Interventions
DEVICEMyEllevate Procedure
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.
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Aesthetic Improvement Score (PGAIS) | 30 days post last treatment | The physician will grade the improvement that they see at the 30 day follow up (30 days post treatment). They will grade them as one of the following: Very Much Improved, Much Improved, Improved, No Change, or Worsened. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment for MyEllevate Procedure The subjects were treated with the MyEllevate procedure.
MyEllevate Procedure: 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Treatment for MyEllevate Procedure | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | — |
| Fitzpatrick Skin Types Fitzpatrick Skin Type I | 1 Participants | — |
| Fitzpatrick Skin Types Fitzpatrick Skin Type II | 2 Participants | — |
| Fitzpatrick Skin Types Fitzpatrick Skin Type III | 5 Participants | — |
| Fitzpatrick Skin Types Fitzpatrick Skin Type IV | 2 Participants | — |
| Fitzpatrick Skin Types Fitzpatrick Skin Type V | 0 Participants | — |
| Fitzpatrick Skin Types Fitzpatrick Skin Type VI | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 4 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Physician Global Aesthetic Improvement Score (PGAIS)
The physician will grade the improvement that they see at the 30 day follow up (30 days post treatment). They will grade them as one of the following: Very Much Improved, Much Improved, Improved, No Change, or Worsened.
Time frame: 30 days post last treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment for MyEllevate Procedure | Physician Global Aesthetic Improvement Score (PGAIS) | Very Much Improved | 5 Participants |
| Treatment for MyEllevate Procedure | Physician Global Aesthetic Improvement Score (PGAIS) | Much Improved | 3 Participants |
| Treatment for MyEllevate Procedure | Physician Global Aesthetic Improvement Score (PGAIS) | Improved | 2 Participants |
| Treatment for MyEllevate Procedure | Physician Global Aesthetic Improvement Score (PGAIS) | No Change | 0 Participants |
| Treatment for MyEllevate Procedure | Physician Global Aesthetic Improvement Score (PGAIS) | Worsened | 0 Participants |