A Study to Assess Non-Invasive Subcutaneous Fat Reduction in the Submental, Inner Thigh and Back/Bra Areas With the CoolSculpting Elite System
Not Applicable
Recruiting
- Conditions
- Non-Surgical Fat Reduction
- Registration Number
- NCT07122583
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 102
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pacific Clinical Innovations
🇺🇸Vista, California, United States
Pacific Clinical Innovations🇺🇸Vista, California, United States