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Completed

NCT Number: NCT03428243

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

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

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Key information

Conditions

Abdominal Fat

Age range

24 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cutera Research Center

Brisbane, California, 94005, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

truSculpt

Device

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

Primary outcomes

  1. Circumference Measurement

    Time frame: 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 outcomes

  1. Device Safety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cutera Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2018
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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