Body Fat
Conditions
Keywords
Radio frequency, thigh, circumference, reduction
Brief summary
The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.
Detailed description
The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).
Interventions
DEVICETrusculpt (Radio Frequency) Device
Sponsors
Cutera Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female * Minimum age of 18 years * Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study. * Post-menopausal, or on birth control and/or no plans to become pregnant for the duration of the study. * Body Mass Index (BMI) ≤ 30 * Visible fat in the thigh / saddlebag area to be treated * Subject must be able to read, understand and sign the Consent Form * Subject must adhere to the follow-up schedule and study instructions * Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study (within 6 lbs of the weight measure at the baseline assessment)
Exclusion criteria
* Taking weight-loss medications/supplements * Simultaneous participation in any other clinical study * Prior surgical treatment to the target area, e.g., liposuction or abdominoplasty * Prior treatment to the target area within the last 12 months e.g., radio frequency or cryolysis * Arteriosclerosis or weakened blood vessels * Heart disease * Thromboembolic disease * Diagnosed or documented immune system disorders (including Panniculitis) * Bleeding disorders * Presence of uncontrolled hypertension * Taking prescription anticoagulants * History of keloid formation * History of malignant tumors in the target area * Diabetes * Any disease or condition that could impair wound healing * Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles * Infection in the target area * Implanted electrical device(s) or metallic implants * Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Thigh Circumference From Baseline | Comparison of Baseline to 12 weeks post- final treatment | Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects Subjects received RF treatments on one upper thigh (lateral and/or frontal and/or medial and/or posterior sides) according to randomization assignment and the opposite thigh served as the control. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 41 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Change of Thigh Circumference From Baseline
Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.
Time frame: Comparison of Baseline to 12 weeks post- final treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treated Thigh | Change of Thigh Circumference From Baseline | .98 cm |
| Contra-lateral Untreated Thigh | Change of Thigh Circumference From Baseline | .32 cm |