UltraShape Power Device for Fat Reduction in Flanks

Syneron Medical

Status

Withdrawn

Conditions

Excess Abdominal Fat

Treatments

Device: UltraShape Power device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03502473

DHF24961

Details and patient eligibility

About

Prospective, baseline-controlled evaluation of the UltraShape Power device for non-invasive fat reduction in flanks.

Full description

Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device according to the study protocol.

One random flank will be treated with one pass or remained as a control (no treatment) while the second flank will be treated with multiple passes.

Subjects will return for up to 4 follow up visits: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks following end of treatment/s.

Each subject will be enrolled for total expected study duration of up to 28 weeks.

After last follow up visit, subjects who wish will receive compensation treatments (up to 3) on the flank who received regular treatment (single pass) or remained as a control (no treatment).

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Signed informed consent to participate in the study.
Female and male subjects, 18 and 65 years of age at the time of enrolment
Fitzpatrick Skin Type I to VI.
Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
BMI interval: 19 ≤ BMI ≤ 30 (normal to overweight, but not obese).
If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
In addition, negative pregnancy inquiry as reviewed before each treatment and each follow up visit for women with bearing potential (e.g. not menopause).
General good health confirmed by medical history and skin examination of the treated area.
Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
Willingness to refrain from a change in diet/ exercise/medication regimen for the entire 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 criteria

History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions
Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone
Having undergone any other surgery in the treated areas within 3 months of treatment or 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 poor wound healing
Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores prior to treatment (duration of resolution as per the Investigator'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 treatment area
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 count within the last 3 months
Obesity (BMI > 30)
Childbirth within the last 12 months or breastfeeding women. Any acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study
Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
Inability to comply with fat measurement procedures (e.g., inability to hold breath for few seconds).
Fat thickness lower than 1.5 cm before strapping at the treated area.
Participation in another clinical study involving same anatomical areas within the last 6 months (or 30 days in case different anatomical areas were treated in previous trial/s).
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.