UltraShape Power Device for Fat Reduction in Flanks

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

Detailed Description
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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).

Official Title
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Clinical Assessment to Evaluate UltraShape Power Device Performance for Flanks Fat Reduction

Conditions
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Excess Abdominal Fat

Intervention / Treatment
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* Device: UltraShape Power device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Flanks will be randomized in accordance with randomization list. One flank will receive a single treatment pass or no treatment. The other side will receive multiple passes (up to 5 passes) during the same treatment session.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One pass/no treatment arm<br>One random flank will be treated with UltraShape Power device with one pass or remained as a control (no treatment) | Device: UltraShape Power device<br>* UltraShape Power is a non-invasive focused ultrasound device, approved by the FDA (160896K;170370K); CE; Israeli Ministry of Health. The UltraShape Power system works by emitting acoustic waves of focused ultrasonic energy (200 ± 30 KHz frequency) that converge into a confined focal volume underneath the skin, thereby, targeting only subcutaneous fat at a controlled depth. Unlike traditional ultrasound technology, UltraShape Power's energy transmits pulsed ultrasound, allowing control over temperature elevation. The system comprised of two main parts: The Main console Transducer<br>|
| Experimental: Multiple passes treatment arm<br>Second flank will be treated with UltraShape Power device with multiple passes. | Device: UltraShape Power device<br>* UltraShape Power is a non-invasive focused ultrasound device, approved by the FDA (160896K;170370K); CE; Israeli Ministry of Health. The UltraShape Power system works by emitting acoustic waves of focused ultrasonic energy (200 ± 30 KHz frequency) that converge into a confined focal volume underneath the skin, thereby, targeting only subcutaneous fat at a controlled depth. Unlike traditional ultrasound technology, UltraShape Power's energy transmits pulsed ultrasound, allowing control over temperature elevation. The system comprised of two main parts: The Main console Transducer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Volume reduction | MRI measurements for fat thickness in cc (cubic centimeter) | 12 weeks follow-up (12wk FU) versus baseline | 
| Treatment Safety as Assessed by Blood Lipid Level | Verification similar of post-treatment and pre-treatment (baseline) blood lipid levels values [%] | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Measurement of Fat Thickness Reduction | MRI measurements for Fat thickness in mm | 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline. | 
| Ultrasound Measurement of Fat Thickness Reduction | Ultrasound measurements for Fat thickness in mm | 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline. | 
| Fat Volume reduction | MRI measurements for fat thickness in cc (cubic centimeter) | 4 weeks, 8 weeks and (optional) 24 weeks versus baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fat flanks