Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction

Completed

Conditions studied: Abdominal Fat

In brief

A long-term follow-up study to evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.

Key facts

Study ID

NCT03428243

Run by

Cutera Inc.

People needed

14

Starts

2017-07-12

Expected to finish

2017-12-01

Last updated by the study team

2018-03-20

Who can join

Age: 24 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Completed participation in the Treatment Group of Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction"
• Subject has maintained the same weight since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction", within 5% of baseline weight measurement.

You may not qualify if…

• Participation in a clinical trial of another device or drug in the target area since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction".
• Any type of cosmetic treatment to the target area to reduce circumference since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction" e.g., radiofrequency, cryolysis or light-based treatments.
• Any invasive cosmetic surgery to the target area, such as liposuction, since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction".
• Newly diagnosed (since enrolling in Protocol C-16-TS11) significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
• Newly diagnosed or documented (since enrolling in Protocol C-16-TS11) immune system disorders.
• Current infection, dermatitis, rash or other skin abnormality in the treatment area.
• Currently undergoing systemic chemotherapy or radiation treatment for cancer, or treatment in the target area since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction".
• Pregnant or currently breastfeeding.
• As per the Investigator's discretion, any physical or mental condition which might make 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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