Status:
COMPLETED
Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat
Lead Sponsor:
Cutera Inc.
Conditions:
Body Fat
Eligibility:
All Genders
24-60 years
Phase:
NA
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 wil...
Eligibility Criteria
Inclusion
- Male or Female, 24 to 60 years of age (inclusive)
- Fitzpatrick Skin Type I - VI (Appendix 3)
- Has visible fat bulges or skin laxity in the abdominal region
- Scheduled to undergo surgery (abdominoplasty).
- Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
- Subject must agree to not undergo any other procedure(s) in the abdominal region during the study period.
- Subject must be able to read, understand and sign the Informed Consent Form.
- Subject must adhere to the follow-up schedule and study instructions.
- Subject must adhere to the same diet/ exercise/medication regimen for the entire course of the study.
- Willing to provide histology samples during the surgery from the intended to be harvested areas.
- 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
- Participation in a clinical trial of another device or drug in the target area during the study period.
- Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolysis or light-based treatments.
- Any prior invasive cosmetic surgery to the target area, such as liposuction.
- Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
- Has metal implant(s) within the body, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
- Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
- Diagnosed or documented immune system disorders.
- History of any disease or condition that could impair wound healing.
- History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
- History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing in the treatment area.
- Infection, dermatitis, rash or other skin abnormality in the target area.
- Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
- Pregnant or currently breastfeeding.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Key Trial Info
Start Date :
June 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03433417
Start Date
June 15 2017
End Date
March 15 2018
Last Update
March 17 2023
Active Locations (1)
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1
Cutera Research Center
Brisbane, California, United States, 94005