Feasibility Study of the TruSculpt Radiofrequency Device

Completed · Not applicable

Conditions studied: Tissue Tightening

In brief

A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency device.

Key facts

Study ID

NCT03018587

Run by

Cutera Inc.

People needed

23

Starts

2017-01-01

Expected to finish

2017-12-29

Last updated by the study team

2023-03-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or Female, 18 to 70 years of age (inclusive)
• Fitzpatrick Skin Type I - VI
• Has visible fat bulges,skin laxity, or cellulite in the treatment area
• 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 treatment area 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.
• Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
• 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.

You may not qualify if…

• Participation in a clinical trial of another device or drug in the target area during the study period.
• 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 that is local to the treatment area, 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.
• 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.

Where it is running

• Cutera Research Center — Brisbane, California, United States

Full record on ClinicalTrials.gov

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