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

NCT03428243 | Completed FDA Device

• 1 other identifier: C-17-TS15
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdominal Fat

Outcome Measures

Primary Outcomes (1)

• Circumference Measurement

  Comparison of Abdominal region Measurement in cm 18 months post-treatment with C-16 TS11 Baseline.

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

Secondary Outcomes (1)

• Device Safety

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

Study Arms (1)

truSculpt

truSculpt effectiveness after 18 months

Device: truSculpt

Interventions

truSculpt DEVICE

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

truSculpt

Eligibility Criteria

• Age: 24 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

14 Subjects from C-16-TS11 participants followed up for measurement

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

Cutera Research Center

Brisbane, California, 94005, United States

Location

Study Officials

• Stephen Ronan, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 9, 2018
• Study Start: July 12, 2017
• Primary Completion: November 6, 2017
• Study Completion: December 1, 2017
• Last Updated: March 20, 2018

Record last verified: 2018-02

Locations

US (1)