Trials / Completed
CompletedNCT05590039
Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure
Prospective Clinical Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Cynosure, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-07-08
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
- First posted
- 2022-10-21
- Last updated
- 2024-08-20
- Results posted
- 2024-08-20
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05590039. Inclusion in this directory is not an endorsement.