Body Fat, Bulging
Conditions
Brief summary
An exploratory pilot study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device
Detailed description
This is a multi-center, pilot study in approximately 40 subjects, ages 18 to 65. Subjects will receive treatments and will be followed at 12 weeks post final treatment.
Interventions
DEVICEtruSculpt
Subjects will receive utreatments and will be followed at 12 weeks post final treatment.
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject must be able to read, understand and sign the Informed Consent Form. 2. Female or Male, 18 to 65 years of age (inclusive). 3. Subject has visible fat bulges in the area to be treated. 4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study. 5. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period. 6. Subject must adhere to the follow-up schedule and study instructions. 7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study. 8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes. 9. For female subjects: not pregnant or lactating and is either post-menopausal, 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.
Exclusion criteria
1. Participation in a clinical trial of another device or drug within 3 months of study participation, or during the study period. 2. Any type of prior cosmetic treatment to the target area within 6 months of study participation. 3. Any prior invasive cosmetic surgery to the target area, such as liposuction. 4. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant. 5. Has metal implant(s) within the body, such as artificial heart valves. 6. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion. 7. History of any disease or condition that could impair wound healing. 8. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing. 9. Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion. 10. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation. 11. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Fat Assessment by Investigator | 12 weeks post final treatment | Degree of Improvement in body fat as assessed by Investigator using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, and 0=No Change Higher scores indicate better outcomes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| truSculpt Treatment with the truSculpt RF device | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | truSculpt |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 9 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Body Fat Assessment by Investigator
Degree of Improvement in body fat as assessed by Investigator using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, and 0=No Change Higher scores indicate better outcomes
Time frame: 12 weeks post final treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| truSculpt | Body Fat Assessment by Investigator | 1.88 score on a scale | Standard Deviation 1.13 |