An interventional study of MyEllevate Procedure in Soft Tissue Approximation, Elevation of Subdermis and Elevation of Underlying Muscle, sponsored by Cynosure, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Cynosure, Inc. · Not applicable, Interventional, and Treatment
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.
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.
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.
The subjects were treated with the MyEllevate procedure.
Device: 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.
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
| Milestone | Treatment for MyEllevate Procedure |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
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.
| Participants | Treatment for MyEllevate Procedure |
|---|---|
| Very Much Improved | 5 |
| Much Improved | 3 |
| Improved | 2 |
| No Change | 0 |
| Worsened | 0 |
Collected over Adverse events were collected until 90 days post treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment for MyEllevate Procedure | 0/10 (0%) | 0/10 (0%) | 4/10 (40%) |
| Event | Treatment for MyEllevate Procedure |
|---|---|
| BruisingSkin and subcutaneous tissue disorders | 3/10 |
| EdemaSkin and subcutaneous tissue disorders | 1/10 |
| RashSkin and subcutaneous tissue disorders | 1/10 |
| Pain/tendernessSkin and subcutaneous tissue disorders | 1/10 |
| Skin discolorationSkin and subcutaneous tissue disorders | 1/10 |
| Skin redundancySkin and subcutaneous tissue disorders | 1/10 |
| Age, Categorical(Participants) | Treatment for MyEllevate Procedure |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Treatment for MyEllevate Procedure |
|---|---|
| Female | 10 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Treatment for MyEllevate Procedure |
|---|
| Fitzpatrick Skin Types(Participants) | Treatment for MyEllevate Procedure |
|---|---|
| Fitzpatrick Skin Type I | 1 |
| Fitzpatrick Skin Type II | 2 |
| Fitzpatrick Skin Type III | 5 |
| Fitzpatrick Skin Type IV | 2 |
| Fitzpatrick Skin Type V | 0 |
| Fitzpatrick Skin Type VI | 0 |
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Plan to share: No
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Cynosure, Inc.