Phase
Condition
Liposuction
Treatment
N/AClinical Study ID
Ages 25-45 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written Informed Consent;
Subjects agreeing to take part of all procedures of the study (including mechanicalmassage, photographs), after being fully informed on the objectives and nature of theinvestigations;
Female subjects between 25-45 years;
Subjects presenting with cellulite grades I-III on buttocks and thighs;
Medical history and physical examination which, based on the investigator’s opinion,do not prevent the patient from taking part in the study and use the device underinvestigation;
Female subjects of childbearing age should present a negative urine pregnancy test andshould be using an effective contraceptive method (3 months before the enrollementuntill the end of the study);
Body Mass Index (BMI = weight/height2) beetwen 20,0-25,0 and 25,0-29,9;
Availability of the subject throughout the duration of the study (90 days);
Availability of the subject in maintaining a stable weight during the study (variationless than 2 kg)
Subjects with sufficient schooling and awareness to enable them to cooperate to thedegree required by this protocol.
Exclusion
Exclusion Criteria:
Pregnant women or women intending to become pregnant during the study (next 3 months);
BMI superior 30,0;
Subjects with diabetes mellitus, cardiac insufficiency, asthma, or bronchitis;
Subjects participating in other clinical trials;
Subjects with neoplastic disorders, uncontrolled thyroid disorders or uncontrolledhypertension;
Subjects with coagulation disorders, using anticoagulants or tendency of bruises;
Subjects with vascular disorders (phlebitis or varicose veins) in the area to betreated;
Any prior aesthetic surgery affecting the area to be treated (liposuction,Subcision®), 3 months before the study, that may interfere with results;
Any other prior anti-cellulite treatment or body measures treatment, 30 days prior tothe study;
Subjects with inflammation or active infection in the area to be treated.
Subjects with a history of adverse effects, which in the investigator’s opinion shouldprevent the patient from participating in the study;
Patients with cutaneous or vascular alterations, that difficult visualization anddocumentation of cellulite;
Subjects with a history of medical treatment non-adherence or showing unwillingness toadhere to the study protocol;
Subjects who can not come to the visits (one missing visit/ month is allowed);
Subjects intending to initiate any intensive sport;
Subjects using analgesics, non-hormonal antiinflammatories, antihistaminics,corticosteroids, or diuretics;
Subjects tanned, or intending to expose the area of study to sun, artificial UV, orself-tanning during the study;
Any condition that, in the opinion of the investigator, can compromise the evaluationof the study.