Tissue Tightening
Conditions
Brief summary
A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency device.
Detailed description
A single-center, prospective, open-label study to evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for optimal delivery of thermal energy to the skin.
Interventions
DEVICETruSculpt
All subjects will receive 1 truSculpt radiofrequency 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 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or Female, 18 to 70 years of age (inclusive) 2. Fitzpatrick Skin Type I - VI 3. Has visible fat bulges,skin laxity, or cellulite in the treatment area 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 area during the study period. 6. Subject must be able to read, understand and sign the Informed Consent Form. 7. Subject must adhere to the follow-up schedule and study instructions. 8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes. 9. 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
1. Participation in a clinical trial of another device or drug in the target area during the study period. 2. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant. 3. Has metal implant(s) within the body that is local to the treatment area, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints. 4. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders. 5. Diagnosed or documented immune system disorders. 6. History of any disease or condition that could impair wound healing. 7. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen. 8. Infection, dermatitis, rash or other skin abnormality in the target area. 9. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation. 10. Pregnant or currently breastfeeding. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Assessment of Improvement | 12 weeks post-treatment | Degree of improvement in the treatment area at 12 weeks post-treatment compared with Baseline photo as assessed by the Investigator using Global Aesthetic Improvement Scale(GAIS): 4 = Very Significant Improvement (\>75%), 3 = Significant Improvement (51 - 75%), 2 = Moderate Improvement (26 - 50%), 1 = Mild Improvement (5 - 25%), or 0 = No Change (\<5%) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects will receive 1 truSculpt radiofrequency treatment in desired area.
TruSculpt: All subjects will receive 1 truSculpt radiofrequency treatment | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 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 | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 4 Participants |
| Visible fat bulges, skin laxity, or cellulite | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 23 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Investigator Assessment of Improvement
Degree of improvement in the treatment area at 12 weeks post-treatment compared with Baseline photo as assessed by the Investigator using Global Aesthetic Improvement Scale(GAIS): 4 = Very Significant Improvement (\>75%), 3 = Significant Improvement (51 - 75%), 2 = Moderate Improvement (26 - 50%), 1 = Mild Improvement (5 - 25%), or 0 = No Change (\<5%)
Time frame: 12 weeks post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Investigator Assessment of Improvement | 0.67 score on a scale | Standard Deviation 0.47 |