Body Contouring Study (Abdomen)
(Cutera, 16 Weeks)
(Cutera, 16 Weeks)
Sadick Research Group is conducting a clinical study assessing a non-invasive body contouring procedure for the abdomen.
Gender: Male and Female
Minimum Age: 21 Years Old
Maximum Age: 50 Years Old
Facility Type: Outpatient
Stipend Range: $100 – $250
Study Length: Approximately 4 Months
Sponsor: Cutera, Inc.
This is single-center, open-label, prospective study of the Cutera truSculpt Flex device to assess the efficacy of this device in improving muscle tone of the abdomen, and in furthering the improvement of body contouring results when paired with treatments with the Cutera truSculpt ID device, which aims to improve body contouring by targeting fat reduction. Enrolled subjects will be assigned to one of three possible treatment arms according to body type and investigator discretion. Participants will either receive one truSculpt ID treatment, one truSculpt ID plus six truSculpt Flex treatments, or six truSculpt Flex treatments. Participants will also be asked to come in for follow-up visits at 8-weeks and/or 12-weeks following their last treatment to assess changes in abdominal circumference and muscle/fat composition. All services are provided at no cost.
Inclusion and Exclusion Criteria
Eligible male and female participants will be 21-50 years of age years of age with a BMI of less than 28 and who are mild to moderately fit. Participants must also agree to maintain their body weight during the course of the study, must refrain from smoking, and must not have smoked for the past 6 months. All participants must agree to have their photographs taken and to not undergo other procedures or treatments in the treatment area of the study. Female subjects cannot plan to be pregnant or breast feeding during the study. Subjects must be available for the office visits during the study and be willing to comply with all study instructions. Participants may not have metal implants, internal pacemakers, or have had procedures performed to the abdomen or flanks within the past 6 months. Several other restrictions and criteria may apply that the study doctor will review with you to determine if you qualify to enter the study.
Other Trial Details
- Physical exam and assessments of study condition to be provided at no cost by an experienced provider.
- No insurance necessary.
- Compensation will be provided at the end of study participation.