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

Cutera

Status: Completed

Conditions: Abdominal Fat

Treatments: Device: truSculpt

Study type: Observational

Funder types: Industry

Identifiers

NCT03428243

C-17-TS15

Details and patient eligibility

About

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

Full description

The purpose of this investigation is to follow-up subjects who have completed participation in the Treatment Group of Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction" for the long-term (18 months) safety and efficacy of the truSculpt radiofrequency (RF) device for circumferential reduction in the abdominal and flank region.

Enrollment: 14 patients

Sex: All

Ages: 24 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Completed participation in the Treatment Group of Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction"
2. 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.

Exclusion criteria

1. 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".
2. 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.
3. 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".
4. 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.
5. Newly diagnosed or documented (since enrolling in Protocol C-16-TS11) immune system disorders.
6. Current infection, dermatitis, rash or other skin abnormality in the treatment area.
7. 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".
8. Pregnant or currently breastfeeding.
9. As per the Investigator's discretion, any physical or mental condition which might make unsafe for the subject to participate in this study.

Trial design

14 participants in 1 patient group

truSculpt

Description:

truSculpt effectiveness after 18 months

Treatment:

Device: truSculpt