Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans

This is an interventional health services research trial for Lipid Metabolism Disorders focused on measuring CoolSculpting, adipose tissue, cryolipolysis, browning Read More

Inclusion Criteria:

• Subject has clearly visible fat in the flanks and/or abdomen, which in the investigator's opinion, may benefit from the treatment.

Subject has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) in the preceding month.

Subject has a BMI of 24.9 to 30. A BMI is defined as weight in kilograms divided by height in meters squared (kg/m2).

Subject 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.

Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.

Exclusion Criteria:

• Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment.

Subject has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months.

Subject 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.

Subject is pregnant or intending to become pregnant. Subject is lactating or has been lactating in the past 6-9 months. Subject is unable or unwilling to comply with study requirements. Subject 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.

Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.

Subject with known history of cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.

Subject with 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 or Raynaud's disease, or Chilblains (pernio).

Subject with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol.

Subject with impaired peripheral circulation in the area to be treated Subject with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.

Subject with impaired skin sensation. Subject with open or infected wounds. Subject with bleeding disorders, or concomitant use of blood thinners, or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.

Subject with recent surgery or scar tissue in the area to be treated. Subject has history of hernia in or adjacent to the treatment area(s) site. Subject with skin conditions such as eczema, dermatitis, or rashes in the area to be treated.

Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).

Subject is taking or has taken diet pills or supplements within the past 6 months.

Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Subject diagnosed with fibrosis.