Evaluation of CoolSculpt Combining Venus Legacy Technology for Enhanced Results in Fat Reduction & Laxity of the Flanks

Launched by VENUS CONCEPT · Oct 2, 2015

Keywords

ClinConnect Summary

Commercially available as the Zeltiq CoolSculpting system, cryolipolysis is FDA cleared for use in the United States for an indication of fat layer reduction in the flanks, thighs, and abdomen through cold-assisted lipolysis. CoolSculpting has been clinically proven to non-surgically reduce subcutaneous fat bulges, allowing patients to achieve noticeable and measurable aesthetic results without the pain, expense, downtime, and risks associated with existing invasive and minimally-invasive procedures. The Zeltiq CoolSculpting System is a non-invasive device designed to cool subcutaneous fat ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects who can read, understand, and sign the Informed Consent Form.
• • Subjects willing and able to comply with all study requirements.
• • Subjects who have pre-scheduled a body contouring procedure.
• • Subjects have clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
• • Subjects have not had weight change exceeding 10 pounds in the preceding month.
• • Subjects agree to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
• Exclusion Criteria:
• • Subjects with active localized or systemic infections.
• • Immuno-compromised subjects.
• • Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
• • In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
• • Subjects with a history of radiation therapy to the treatment area.
• • Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
• • Subject has had a surgical procedure(s) in the area of intended treatment.
• • Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
• • Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
• • Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
• • Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
• • Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
• • Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• • Subject is taking or has taken diet pills or supplements within the past month.
• • 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 has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
• • Subject has a history of hernia in the areas to be treated.
• • Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.