The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction

Body Fat Clinical Trial

Official title:

The Cutera Trusculpt Device For Thigh Circumference Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665118
• Other study ID #: C-12-TS05
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2023
• Source: Cutera Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Fat

Intervention

Device:
• Trusculpt (Radio Frequency) Device

Locations

Country	Name	City	State
United States	Cutera Research Center	Brisbane	California
United States	New Jersey Plastic Surgery	Montclair	New Jersey
United States	Nashville Center for Laser and Facial Surgery	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Cutera Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Comparison of Baseline to 12 weeks post- final treatment