NCT03428243

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
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Cutera Inc. · Industry
• Sex: All
• Age: 24 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Abdominal Fat

Interventions

Type	Name	Description
DEVICE	truSculpt	Device comparison of Circumference measurement at Baseline vs 18 months post treatment

Timeline

• Start date: 2017-07-12
• Primary completion: 2017-11-06
• Completion: 2017-12-01
• First posted: 2018-02-09
• Last updated: 2018-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study