SlimShape Device for Abdominal Fat and Circumference Reduction

Study Overview
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Brief Summary
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Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the SlimShape device for non-invasive abdominal fat and circumference reduction. Study subjects will undergo SlimShape treatments on the abdominal area.

Detailed Description
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The objective of this trial is to evaluate the safety and efficacy of the SlimShape device utilizing the SlimShape Applicator Belt for abdominal non-invasive fat and circumference reduction. Eligible subjects will receive up to 3 bi-weekly treatments (2 weeks interval) with the SlimShape device utilizing the SlimShape Applicator Belt according to the study protocol. The subject will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment. Each subject will be enrolled for total expected study duration of up to 16 weeks.

Official Title
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat and Circumference Reduction

Conditions
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Fat Disorder

Intervention / Treatment
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* Device: SlimShape


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 ≤60 years of age at the time of enrollment Fitzpatrick Skin Type I to VI BMI interval: 18.5 ≤ 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 urine pregnancy test as tested before each treatment and at the last visit for women with childbearing 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. Willing 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 12 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 History of epidermal or dermal disorders (particularly if involving collagen or microvascularity) 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 or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course Allergy to any component of the lotion (VelaSpray Ease) used in this study 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 circumference measurement procedure (e.g., inability to hold breath for the required duration). 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: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal fat reduction treatment<br>SlimShape treatments will be administered for up to 3 sessions to the abdomen of all study participants. | Device: SlimShape<br>* SlimShape radiofrequency treatment to the abdomen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fat Thickness at Final Follow-up Compared to Baseline | Abdominal fat change, measured by ultrasound, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline | Baseline and 12 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fat Thickness After Treatments Compared to Baseline | Abdominal fat change, measured by ultrasound, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline | Baseline and 4 and 8 weeks follow-up | 
| Change in Abdominal Circumference After Treatments Compared to Baseline | Change in abdominal circumference, measured by calibrated measuring tape, at 4, 8 and 12 weeks follow-up (after final treatment) compared to baseline | At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipolysis, fat reduction, circumference reduction