A Study to Assess Non-Invasive Subcutaneous Fat Reduction in the Submental, Inner Thigh and Back/Bra Areas With the CoolSculpting Elite System

Study Identifier
M25-970
CT.gov Identifier
NCT07122583
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Body Enhancement
    • Study Drug
    N/A
    Phase
    Phase 4
    Sex
    Female & Male
    Age
    22 - 65 Years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Pacific Clinical Innovations
    Vista, California, United States, 92083
    Status
    Not applicable