Status:
COMPLETED
Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction
Lead Sponsor:
Cutera Inc.
Conditions:
Abdominal Fat
Eligibility:
All Genders
24-60 years
Brief 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 Cir...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 12 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03428243
Start Date
July 12 2017
End Date
December 1 2017
Last Update
March 20 2018
Active Locations (1)
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1
Cutera Research Center
Brisbane, California, United States, 94005