Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment for MyEllevate Procedure | Experimental | The subjects were treated with the MyEllevate procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyEllevate Procedure | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days post last treatment |
Not provided
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Canavan | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Jersey Plastic Surgery | Montclair | New Jersey | 07042 | United States | ||
| Aesthetic Pavilion Ambulatory Surgery Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31896400 | Result | Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 30 days post last treatment |
|
Adverse events were collected until 90 days post treatment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | (201) 479-9612 | jamie.trimper@cynosure.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2022 | Jul 25, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Staten Island |
| New York |
| 10306 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Fitzpatrick Skin Types | Fitzpatrick Skin Types range from I-VI, with I meaning little melanin and light hair, and VI representing high amounts of melanin and dark hair. Additional details on this scale can be found in the publication cited for the results section. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pain/tenderness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin redundancy | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.