- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02873104
Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Brisbane, California, United States, 94005
- Cutera Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female or Male, 24 to 60 years of age (inclusive). Fitzpatrick Skin Type I - VI. Has visible fat bulges on the abdomen and palpable fat pockets superior to iliac crest located bilaterally in the lower back flank region Has a Body Mass Index (BMI) ≥ 20 and ≤ 30 Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
Subject must agree to not undergo any other procedure(s) in the abdominal and flank region during the study period.
Subject must be able to read, understand and sign the Informed 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 5% of baseline weight measurement.
Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant.
Exclusion Criteria:
- Participation in a clinical trial of another device or drug within 6 months of study participation, or during the study period.
Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolysis or light-based treatments.
Any prior invasive cosmetic surgery to the target area, such as liposuction. Currently taking medications or supplements for weight-loss or metabolism support/enhancement or has a history of taking such medications or supplements within 3 months.
Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
Has metal implant(s) within the body, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
Diagnosed or documented immune system disorders. History of any disease or condition that could impair wound healing. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
Infection, dermatitis, rash or other skin abnormality in the target area. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
Pregnant or currently breastfeeding. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment
truSculpt rf device, therapeutic settings
|
radiofrequency device
|
Sham Comparator: Sham
truSculpt rf device, non-therapeutic settings
|
radiofrequency device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment
Time Frame: 12 weeks
|
Change in Abdominal Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment minus Baseline Measurement
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.
Time Frame: 12 weeks
|
Comparison of the average subject improvement score for the sham group and the therapeutic group at 12 weeks post-treatment using a 0 - 4 improvement scale where 0 equals "no change" and 4 equals "Very Significant Improvement".
|
12 weeks
|
Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.
Time Frame: 12 weeks
|
Comparison of the average subject satisfaction level for the sham group and therapeutic group at 12 weeks post-treatment, using a 1 - 5 scale where 1 equals "very dissatisfied" and 5 equals "very satisfied".
|
12 weeks
|
Subject Discomfort and Pain Levels During Treatment
Time Frame: 12 weeks
|
Comparison of the average pain levels during treatment for the sham group and therapeutic group at 12 weeks post-treatment, using a 0 - 10 scale where 0 equals "No pain" and 10 equals "Worst possible pain".
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- C-16-TS11
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abdominal Fat
-
Syneron MedicalCompletedAbdominal FatUnited States
-
Laser and Skin Surgery Center of New YorkZeltiq AestheticsCompletedAbdominal Fat | Adipose Tissue, AbdominalUnited States
-
Northwestern UniversityActive, not recruiting
-
Cutera Inc.CompletedAbdominal FatUnited States
-
Syneron MedicalCompleted
-
Syneron MedicalWithdrawn
-
Syneron MedicalCompleted
-
Syneron MedicalUnknownExcess Abdominal FatUnited States
-
CAO Group, Inc.CompletedAbdominal Subcutaneous FatUnited States
-
BodyAesthetic Research CenterCompletedAbdominal Subcutaneous FatUnited States
Clinical Trials on truSculpt rf device
-
Cutera Inc.CompletedWrinkle ReductionUnited States
-
Cutera Inc.CompletedTreatment for Cellulite on the Stomach and FlanksUnited States
-
Cutera Inc.Completed
-
Cutera Inc.TerminatedCelluliteUnited States
-
Cutera Inc.Terminated
-
BTL Industries Ltd.CompletedPeriorbital Wrinkles
-
Cynosure, Inc.CompletedWrinkle | Photoaging | DyschromiaUnited States
-
OHH-MED Medical LtdUnknownErectile DysfunctionIsrael
-
Kangbuk Samsung HospitalCutera Inc.Completed
-
InvasixCompletedFacial Wrinkles and Rhytides ReductionCanada