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

Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction: 18-month Circumference Measuing of Some C-16-TS11 Subjects.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03428243

Enrollment

Registered

2018-02-09

Start date

2017-07-12

Completion date

2017-12-01

Last updated

2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Fat

Brief summary

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

Detailed 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.

Interventions

DEVICEtruSculpt

Device comparison of Circumference measurement at Baseline vs 18 months post treatment

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

24 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Circumference Measurement	18 months post C-16-TS11 completion (September, 2016)	Comparison of Abdominal region Measurement in cm 18 months post-treatment with C-16 TS11 Baseline.

Secondary

Measure	Time frame	Description
Device Safety	18 months post C-16-TS11 completion (September, 2016)	Measurement of Resolved Adverse Events from Radiofrequency (RF) treatment (C-16-TS11), and Presence of any Additional AE within 18 months of RF treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026