N/A
N=44
The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction
Body Fat
Bottom Line
View on ClinicalTrials.gov: NCT01665118 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Change of Thigh Circumference From Baseline — .98; .32 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trusculpt (Radio Frequency) Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cutera Inc.
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Thigh Circumference From Baseline |
.98; .32 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01665118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.