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Prospective clinical study to evaluate the Profound efficiency Up to 60 healthy adult volunteers, male or females, 18 to 70 years old. All subjects in this study will receive a single treatment to the submental area with the profound device; subjects will return to four follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment.
Prior to treatment, tissue will be treated with injected tumescence or local dermal infiltration solution according to the protocol.
This study is a Prospective clinical study to evaluate the Profound device for submental laxity.
Up to a total of 60 healthy candidates, seeking treatment for submental laxity. Subjects will receive one Profound treatment targeted to both dermal and subcutaneous layer of the skin.
Before treatment (15-20 minutes) the tissue to be treated will be injected with tumescence solution.
Each subject will be followed for additional four (4) post treatment visits
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all subjects | Experimental | All subjects in this study will receive a single Profound system treatment to the submental area with the profound device; subjects will return to four follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment. Prior to treatment, tissue will be treated with injected tumescence or local dermal infiltration solution according to the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profound System | Device | The Profound system is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of submental laxity |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Performance of Profound system to the skin's surface for submental laxity | using Fitzpatrick Wrinkle and Alexiades-Armenakas Laxity Scales | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| safety of the profound single treatment by record of the Number, severity and type of adverse events | Number, severity and type of adverse events recorded | from day 0 until 6 months |
| Investigator satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Beaty, M.D. | Beaty Facial Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Plastic Surgery | San Mateo | California | 94401 | United States | ||
| Gladstone Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17173575 | Background | Ruiz-Esparza J. Nonablative radiofrequency for facial and neck rejuvenation. A faster, safer, and less painful procedure based on concentrating the heat in key areas: the ThermaLift concept. J Cosmet Dermatol. 2006 Mar;5(1):68-75. doi: 10.1111/j.1473-2165.2006.00226.x. |
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assessed by Investigator
| day 0, 1, 3, and 6 months |
| Subject Satisfaction | by Subject questionnaire | 1, 3, and 6 months |
| Subject pain assessment | using Numerical Scale Response (NSR) | day 0 (treatment) |
| San Ramon |
| California |
| 94583 |
| United States |
| Mark Beaty | Alpharetta | Georgia | 30009 | United States |
| Coliseum Health System | Macon | Georgia | 31217 | United States |
| Dr. Richard Gentile | Boardman | Ohio | 44512 | United States |