Tightening of Skin Laxity
Conditions
Keywords
skin laxity, wrinkles, rhytids
Brief summary
The purpose of this feasibility study is to gain an initial assessment of the acute safety and performance of the Apsara Thermal Wand System in human facial tissue.
Interventions
DEVICEApsara Thermal Wand System
Single radiofrequency cycle to dermal tissue
Sponsors
Apsara Medical Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Nonsmoker * Glogau class 1-3 * Previously chosen to undergo facelift
Exclusion criteria
* Pregnant, nursing * Implanted electro-mechanical device * Allergy to anesthesia or device metals * Collagen vascular disease * History of keloid or hypertrophic scar formation * Uncontrolled diabetes * Long term steroid or other immunologic inhibitor use * Previous treatment to target area * Does not consent to study * Does not consent to photography or histological evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | Immediate | Number of Serious Adverse Events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A--Thermal Wand Application | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | A--Thermal Wand Application |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age Continuous | 61.7 years STANDARD_DEVIATION 3.6 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Outcome results
Primary
Serious Adverse Events
Number of Serious Adverse Events
Time frame: Immediate
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A--Thermal Wand Application | Serious Adverse Events | 0 Number of Serious Adverse Events |