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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03428243
Other study ID # C-17-TS15
Secondary ID
Status Completed
Phase
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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