CoolSculpting® Elite for Non-Invasive Fat Reduction
Condition: Non-invasive Fat Reduction
Intervention: CoolSculpting® Elite System with CoolSculpting® Elite applicators
Intervention description: A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 22 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fat Reduction Non-invasive

Summary:

      This study aims to generate data that conveys participant's experiences such as their
      satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for
      non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to
      optional body areas of upper arms, inner thighs, outer thighs and/or submental area. By doing
      this, the study will provide insights for doctors to better inform participants about the
      expected outcomes when one or more body areas are considered for treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria:

          -  Participant must be in good health as determined by medical history, physical
             examination, vital signs, and investigator's judgment, including no known active
             pandemic infection.

          -  Participant has clearly visible and palpable fat in the abdomen and flanks, and
             participant may also be assessed for visible and palpable fat in one or more of the
             following body areas: left and right lower aspects of the upper arms, left and right
             inner thigh, left and right outer thigh, or submental area, which in the
             investigator's opinion is appropriate for and may benefit from treatment.

          -  Participant has a BMI of ≥ 18.5 and < 30. BMI is defined as weight in kilograms
             divided by height in meters squared (kg/m2).

          -  Participant agrees to maintain weight (ie, within 5% of body weight) by not making any
             changes in diet or exercise routine during the course of the study.

          -  Participant agrees to have photographs taken of the treatment area(s) during the
             scheduled time periods.

        Exclusion Criteria:

          -  Participant has a history of an invasive fat reduction procedure (eg, liposuction,
             surgery, lipolytic agents, etc) within or adjacent to the area being considered for
             treatment.

          -  Participant has implants (eg, breast implants) in or immediately adjacent to the area
             of intended treatment.

          -  Participant has a history of prior surgery or scar tissue related to the area being
             considered for treatment.

          -  Participant has a known history of cryoglobulinemia, cold urticaria, cold agglutinin
             disease, or paroxysmal cold hemoglobinuria.

          -  Participant has a known sensitivity to cold or has any condition with a known response
             to cold exposure that limits blood flow to the skin, such as cold urticaria, Raynaud's
             disease, or chilblains (pernio).

          -  Participant with a clinically significant bleeding disorder, or concomitant use of
             blood thinners, or is taking any medication that, in the investigator's opinion, may
             significantly increase the participant's risk of bruising or bleeding.

          -  Participant has a history of carpal tunnel syndrome, compartment syndrome, or deep
             vein thrombosis in the upper or lower extremities (only applicable for participants
             receiving treatment to the upper arms or thighs).

          -  Participant is currently taking or has taken diet pills or weight control supplements
             within the past 6 months.

          -  Participant has any skin conditions, such as moderate to excessive skin laxity, open
             wound, or scars, and active infection, eczema, dermatitis or rashes in the location of
             the treatment sites that may interfere with the treatment or evaluation (stretch marks
             are not an exclusion).

          -  Participant has an active implanted device such as a pacemaker, defibrillator, drug
             delivery system, or any other metal-containing implant, within or adjacent to the area
             being considered for treatment.

          -  Participant (WOCBP- woman of childbearing potential) is pregnant or intending to
             become pregnant in the next 3 to 6 months and does not agree to use reliable
             contraception during the study.

          -  Participant is lactating or has been lactating in the past 6 months.

          -  Participant is unable or unwilling to comply with the study requirements.

          -  Participant is currently enrolled in a clinical study of any unapproved
             investigational device, investigational product, or any other type of medical research
             judged not to be scientifically or medically compatible with this study.

          -  Participant has any other condition or laboratory value that would, in the
             professional opinion of the investigator, potentially affect the participant's
             response or the integrity of the data or would pose an unacceptable risk to the
             participant.

          -  Participant has had a non-invasive fat reduction and/or body contouring procedure in
             the area(s) of intended treatment within the past 12 months.

          -  Participant needs to administer, or has a known history of subcutaneous injections,
             into the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the
             past 6 months.

          -  Participant with known sensitivity or allergy to fructose, glycerin, isopropyl
             alcohol, or propylene glycol.

          -  Participant has impaired peripheral circulation in the area to be treated.

          -  Participant has neuropathic disorders such as post-herpetic neuralgia or diabetic
             neuropathy.

          -  Participant has impaired skin sensation in or immediately adjacent to the treatment
             area(s).

          -  Participant has a history of hernia in or immediately adjacent to the treatment
             area(s).

          -  Participant diagnosed with a systemic fibrosing disease or fibrosis in the area
             intended or adjacent to the area to be treated.