Body Fat
Conditions
Brief summary
Clinical Study to Evaluate the Performance the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat
Detailed description
A single-center, prospective, non-randomized, open-label study to evaluate the truSculpt Radiofrequency Device for non-invasive fat reduction in abdominal tissue for up to 14 subjects. Measurement will be histological evaluation of tissue for selective fat necrosis, with sparing of the dermis and epidermis, following truSculpt treatment vs. untreated contralateral control.
Interventions
DEVICECutera truSculpt
One truSculpt treatment delivered 0 to 90 days before scheduled Abdominoplasty to one side of the tissue to be removed during abdominoplasty
Sponsors
Cutera Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or Female, 24 to 60 years of age (inclusive) 2. Fitzpatrick Skin Type I - VI (Appendix 3) 3. Has visible fat bulges or skin laxity in the abdominal region 4. Scheduled to undergo surgery (abdominoplasty). 5. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study. 6. Subject must agree to not undergo any other procedure(s) in the abdominal region during the study period. 7. Subject must be able to read, understand and sign the Informed Consent Form. 8. Subject must adhere to the follow-up schedule and study instructions. 9. Subject must adhere to the same diet/ exercise/medication regimen for the entire course of the study. 10. Willing to provide histology samples during the surgery from the intended to be harvested areas. 11. 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. Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolysis or light-based treatments. 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 surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints. 6. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders. 7. Diagnosed or documented immune system disorders. 8. History of any disease or condition that could impair wound healing. 9. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen. 10. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing in the treatment area. 11. Infection, dermatitis, rash or other skin abnormality in the target area. 12. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation. 13. Pregnant or currently breastfeeding. 14. 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 |
|---|---|---|
| Number of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response | 0 to 90 days | Descriptive histological evaluation of abdominal tissue for selective fat necrosis, with sparing of the dermis and epidermis, following one truSculpt treatment vs. untreated bilateral control. A responder is a biopsy sample that shows necrosis or inflammatory immune cell response. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants One truSculpt treatment
Cutera truSculpt: one truSculpt treatment before scheduled Abdominoplasty on tissue to be removed during abdominoplasty | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 12 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response
Descriptive histological evaluation of abdominal tissue for selective fat necrosis, with sparing of the dermis and epidermis, following one truSculpt treatment vs. untreated bilateral control. A responder is a biopsy sample that shows necrosis or inflammatory immune cell response.
Time frame: 0 to 90 days
Population: 24 biopsy samples were collected; however, the treatment side and untreated bilateral control side biopsy samples from 1 participant were lost during transit to the histology lab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Participants - Treatment Side | Number of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response | 10 Participants |
| All Study Participants - Untreated Bilateral Control Side | Number of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response | 0 Participants |