Treatment for Cellulite on the Stomach and Flanks
Conditions
Brief summary
Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
Detailed description
This study will evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
Interventions
DEVICECutera truSculpt Device
The Cutera truSculpt Device uses radio frequency (RF) energy to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as temporary reduction in the appearance of cellulite.
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open label study.
Intervention model description
A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.
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 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 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 1 month 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. Allergy or sensitivity to Tegaderm. 12. 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 |
|---|---|---|
| GAIS at 12 Weeks Post Final Treatment | 12 weeks post final treatment | Global Aesthetic Improvement Scale will be assessed at 12 weeks post final treatment by the investigator by comparing against Baseline photos Higher scores indicate better outcomes 0= No change 1. Mild Improvement 2. Moderate improvement 3. Significant Improvement |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment With the truSculpt RF Device Subjects will be treated with the truSculpt RF device | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Treatment With the truSculpt RF Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 22 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
GAIS at 12 Weeks Post Final Treatment
Global Aesthetic Improvement Scale will be assessed at 12 weeks post final treatment by the investigator by comparing against Baseline photos Higher scores indicate better outcomes 0= No change 1. Mild Improvement 2. Moderate improvement 3. Significant Improvement
Time frame: 12 weeks post final treatment
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Treatment With the truSculpt RF Device | GAIS at 12 Weeks Post Final Treatment | 2 score on a scale | Standard Deviation 0.94 |