Multi-Center Pilot Study of Cutera truSculpt Device

Launched by CUTERA INC. · Dec 19, 2018

Keywords

ClinConnect Summary

This study will evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.

Gender

ALL

Eligibility criteria

• 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.