Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat
Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat
Clinical Study to Evaluate the Performance the truSculpt Radiofrequency Device for Lipolysis
 of Abdominal Fat
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.
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.