Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: A subject is eligible to participate in the study if he/she meets all the followinginclusion criteria:
Signed informed consent to participate in the study.
Female and male subjects, 18 and 60 years of age at the time of enrollment
Fitzpatrick Skin Type I to VI.
Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
BMI interval: BMI between 22 to 30 (normal to overweight, but not obese).
If female, not pregnant or lactating, must be either post-menopausal, surgicallysterilized, or using a medically acceptable form of birth control at least 3 monthsprior to enrollment (i.e. oral contraceptives, contraceptive implant, barrier methodswith spermicide or abstinence).
In addition, negative urine pregnancy test as tested before each treatment and at thelast follow-up visit for women with child-bearing potential (e.g. not menopause).
General good health confirmed by medical history and skin examination of the treatedarea.
Willing to follow the treatment and follow-up schedule and post-treatment careinstructions.
Willingness to refrain from a change in diet/ exercise/medication regimen for theentire course of the study.
Willing to have photographs and images taken of the treated areas to be used,de-identified in evaluations, publications and presentations
Exclusion
Exclusion Criteria: A subject is not eligible for participation in this study if he or she meets any of thefollowing exclusion criteria:
History of hypertension, ischemic heart disease, valvular heart disease, congestiveheart failure, pacemaker or defibrillator, abdominal aortic aneurism
Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positivestatus, blood coagulopathy or excessive bleeding, autoimmune or connective tissuedisease
Having or undergoing any form of treatment for active cancer, or having a history ofskin cancer or any other cancer in the areas to be treated, including presence ofmalignant or pre‐malignant pigmented lesions
Having any active electrical implant anywhere in the body, such as a pacemaker or aninternal defibrillator
Having a permanent implant in the treated area, such as metal plates or an injectedchemical substance such as silicone
Having undergone any other surgery in the treated areas within 12 months of treatmentor during the study, including liposuction
Previous body contouring procedures in the treatment area within 12 months
History of skin disease in the treatment area, known tendency to form keloids or poorwound healing
Suffering from significant skin conditions in the treated areas or inflammatory skinconditions, including, but not limited to, open lacerations or abrasions and activecold sores or herpes sores prior to treatment (duration of resolution as per theInvestigator's discretion) or during the treatment course
Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatmentarea
Very poor skin quality (i.e., severe laxity)
Abdominal wall diastasis or hernia on physical examination
Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood countwithin the last 3 months
Obesity (BMI above 30)
Childbirth within the last 12 months or breastfeeding women. Any acute or chroniccondition which, in the opinion of the investigator, could interfere with the conductof the study
Unstable weight within the last 6 months (i.e., ± 3 percent weight change in the priorsix months)
Inability to comply with circumference measurement procedure (e.g., inability to holdbreath for the required duration).
Fat thickness lower than 2.5 cm after strapping at the treated area.
Participation in another clinical study involving same anatomical areas within thelast 6 months (or 30 days in case different anatomical areas were treated in previoustrials).
As per the Investigator's discretion, any physical or mental condition which mightmake it unsafe for the subject to participate in this study
Study Design
Study Description
Connect with a study center
Skin Care Physicians
Chestnut Hill, Massachusetts 02467
United StatesCompleted
Zel Skin & Laser Specialists
Edina, Minnesota 55402
United StatesActive - Recruiting
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