Non-Surgical Fat Reduction
Conditions
Keywords
Non-Surgical Fat Reduction, CoolSculpting Elite System
Brief summary
The primary objective of this protocol is the continued collection of data specific to the submental, inner thigh and back/bra body areas with CoolSculpting Elite. The study aims to collect post-market safety data while allowing for the collection of standardized photos and satisfaction questionnaires after treatment with commercial treatment parameters.
Interventions
CoolSculpting Elite Applicator
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant has clearly visible fat on the submental, bilateral inner thigh or bilateral back/bra areas, which in the investigator's opinion, is appropriate for treatment with CoolSculpting Elite. * Participant has not had weight change exceeding 5% of body weight in the preceding month.
Exclusion criteria
* Participant has had a recent surgical procedure in the area of intended treatment within the previous 6 months. * Participant has had previous surgical or invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment. * Participant has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the previous 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Device and/or Procedure-Related Adverse Events (AEs) | Up to Approximately 6 Months | Frequency of device and procedure-related AEs including serious device-related adverse events (SADEs), will be analyzed per cohort. |
Countries
United States
Outcome results
None listed