SlimShape Device for Abdominal Fat and Circumference Reduction

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

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.

Study Overview

• Status: Completed
• Conditions: Fat Disorder
• Intervention / Treatment: Device: SlimShape

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Laser & Skin Surgery Medical Group, Inc
  • Massachusetts
    • Wayland, Massachusetts, United States, 01778
      • Syneron Candela Institute for Education Clinic
  • New York
    • New York, New York, United States, 10003
      • Union Square Laser Dermatology
    • New York, New York, United States, 10016
      • Laser & Skin Surgery Center of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed informed consent to participate in the study.
2. Female and male subjects, ≥18 and ≤60 years of age at the time of enrollment
3. Fitzpatrick Skin Type I to VI
4. BMI interval: 18.5 ≤ BMI ≤ 30 (normal to overweight, but not obese).
5. 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).
6. 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).
7. General good health confirmed by medical history and skin examination of the treated area.
8. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
9. Willing to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
10. Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.

Exclusion Criteria:

1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
3. 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
4. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
5. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone
6. Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction
7. Previous body contouring procedures in the treatment area within 12 months
8. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
9. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity)
10. 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
11. Allergy to any component of the lotion (VelaSpray Ease) used in this study
12. 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
13. Very poor skin quality (i.e., severe laxity)
14. Abdominal wall diastasis or hernia on physical examination
15. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
16. Obesity (BMI > 30)
17. 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
18. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
19. Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).
20. 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).
21. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatments Where Participants Reported Having "Mild", "Moderate" or "Severe" Response	Discomfort and immediate response will be assessed immediately after each treatment using the Post Treatment Immediate Response severity scale (Absent/none, Mild, Moderate and Severe). The values in the data table reflect the number of participants who had discomfort during treatment or immediate response after treatment (reported as having "Mild", "Moderate" or "Severe" )	First, second and third treatments, Weeks 0 to 4

Collaborators and Investigators

• Sponsor: Syneron Medical
• Investigators: Study Director: Ruthie Amir, MD, Syneron Medical

Publications and helpful links

General Publications

• Adatto MA, Adatto-Neilson RM, Morren G. Reduction in adipose tissue volume using a new high-power radiofrequency technology combined with infrared light and mechanical manipulation for body contouring. Lasers Med Sci. 2014 Sep;29(5):1627-31. doi: 10.1007/s10103-014-1564-x. Epub 2014 Apr 1.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2017
• Primary Completion (Actual): May 3, 2018
• Study Completion (Actual): August 7, 2018

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 21, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: lipolysis; fat reduction; circumference reduction
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: DHF22621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No