The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.
ClinicalTrials.gov Identifier:
NCT01665118
First received: August 10, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.


Condition Intervention
Localized Unwanted Fat Bulges (Subcutaneous Adipose Tissue)
Device: Trusculpt (Radio Frequency) Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Cutera Trusculpt Device For Thigh Circumference Reduction

Further study details as provided by Cutera Inc.:

Primary Outcome Measures:
  • Change in thigh circumference from baseline compared to the non-treated contra-lateral side [ Time Frame: At 12 weeks post- final treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject discomfort and pain levels [ Time Frame: During treatment, 4 and 12 weeks post- final treatment ] [ Designated as safety issue: Yes ]
    Numeric Verbal Scale (0-10)

  • Subject Satisfaction [ Time Frame: At 4 and 12 weeks post- final treatment. ] [ Designated as safety issue: No ]
  • Subject's Global Assessment [ Time Frame: At 4 and 12 weeks post- final treatment ] [ Designated as safety issue: No ]
  • Physician's Global Assessment [ Time Frame: At 4 and 12 weeks post- final treatment ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: August 2012
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treated Thigh
Trusculpt (Radio Frequency) Device
Device: Trusculpt (Radio Frequency) Device
No Intervention: Untreated Contra-lateral Thigh
To be used as the self control in this split body study.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665118

Locations
United States, California
Cutera Research Center
Brisbane, California, United States, 94005
United States, New Jersey
New Jersey Plastic Surgery
Montclair, New Jersey, United States, 07042
United States, Tennessee
Nashville Center for Laser and Facial Surgery
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Cutera Inc.
Investigators
Principal Investigator: Brian Biesman, MD
Principal Investigator: Barry DiBernardo, MD
Principal Investigator: Stephen Ronan, MD
  More Information

No publications provided

Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT01665118     History of Changes
Other Study ID Numbers: C-12-TS05
Study First Received: August 10, 2012
Last Updated: August 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cutera Inc.:
Radio frequency
thigh
circumference
reduction

ClinicalTrials.gov processed this record on July 28, 2014