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

Abdominal Fat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428243
• Other study ID #: C-17-TS15
• Status: Completed
• First received: February 5, 2018
• Last updated: March 19, 2018
• Start date: July 12, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: February 2018
• Source: Cutera Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 1, 2017
• Est. primary completion date: November 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Fat

Intervention

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

Locations

Country	Name	City	State
United States	Cutera Research Center	Brisbane	California

Sponsors (1)

Lead Sponsor	Collaborator
Cutera Inc.

Country where clinical trial is conducted

United States, 

Outcome

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