CoolSculpting and RF for the Submental
- Conditions
- Body Fat Disorder
- Interventions
- Device: The ZELTIQ System
- Registration Number
- NCT03873779
- Lead Sponsor
- Zeltiq Aesthetics
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of sequential use of CoolSculpting (Cryolipolysis) and radiofrequency treatment of the submental and submandibular area.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fat Reduction The ZELTIQ System The treatments are designed to see if the fat can be reduced in the submental/submandibular area.
- Primary Outcome Measures
Name Time Method Number of Participants With Unanticipated Adverse Device Effects (UADEs) From date of first treatment to 12 weeks after final treatment (up to 24 weeks) UADEs were defined as any serious adverse effect on health and safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants.
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent) Baseline, 12 weeks post radiofrequency treatment Photos obtained during the study were reviewed by an independent physician reviewer who entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Fat Layer Thickness Baseline, 12 weeks post radiofrequency treatment Fat layer thickness was measured using a caliper at the center of the treatment area.
Number of Participants With Improvement Based on Subject-graded Global Aesthetic Improvement Scale (SGAIS) Baseline, 12 weeks post radiofrequency treatment Participants rated improvement in their treatment areas based on the SGAIS. The SGAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who reported as improved ("Very Much Improved," "Much Improved", and "Improved").
Number of Participants With Positive Response in Subject Self-Rating Scale (SSRS) Score Baseline, 12 weeks post radiofrequency treatment Participants assessed their own satisfaction with their face and chin using the SSRS. The SSRS is a participants self-rating scale, scored on a 7-point scale with 0=extremely dissatisfied, 1=dissatisfied, 2=slightly dissatisfied, 3=neither satisfied nor dissatisfied, 4=slightly satisfied, 5=satisfied, and 6=extremely satisfied, with 6 representing higher participant satisfaction. Reported here is the number of participants with a score of 4 or higher, indicating satisfaction.
Number of Participants With Positive Response on Subject Satisfaction Questionnaire Baseline, 12 Weeks Post Radiofrequency Treatment Participants reported their satisfaction with aspects of treatment on a written questionnaire which included a 5-point Likert scale ranging from -2 to 2, with -2 representing more negative response and 2 representing more positive response. Reported here are the numbers of participants with responses of 1 or 2, indicating a positive response, to the following categories: Comfort of Treatment Procedure, How Visible is Fat Reduction, Overall Effect from the Procedure, Overall Satisfaction with Treatment from the Procedure to the Result, Made Me Look More Youthful, Made My Chin Look More Toned, Feel Less Self-Conscious About Chin Fat, Overall Appearance Has Improved.
Trial Locations
- Locations (1)
Innovation Research Center
🇺🇸Pleasanton, California, United States