CompletedNot Applicable

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

United States14 participantsStarted 2017-07-12

Plain-language summary

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

Age range24 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Circumference Measurement

Timeframe: 18 months post C-16-TS11 completion (September, 2016)

NCT IDNCT03428243

SponsorCutera Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-11-06

Who can participate

Age range24 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.