SlimShape Device for Abdominal Fat and Circumference Reduction

NCT02999763 | Completed Results

• 1 other identifier: DHF22621
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Fat Disorder

Keywords

lipolysis; fat reduction; circumference reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Fat Thickness After Treatments Compared to Baseline

  Baseline and 4 and 8 weeks follow-up

• Change in Abdominal Circumference After Treatments Compared to Baseline

  At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment)

Other Outcomes (1)

• Number of Treatments Where Participants Reported Having "Mild", "Moderate" or "Severe" Response

  First, second and third treatments, Weeks 0 to 4

Study Arms (1)

Abdominal fat reduction treatment

EXPERIMENTAL

SlimShape treatments will be administered for up to 3 sessions to the abdomen of all study participants.

Device: SlimShape

Interventions

SlimShape DEVICE

SlimShape radiofrequency treatment to the abdomen

Abdominal fat reduction treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (4)

Laser & Skin Surgery Medical Group, Inc

Sacramento, California, 95816, United States

Location

Syneron Candela Institute for Education Clinic

Wayland, Massachusetts, 01778, United States

Location

Union Square Laser Dermatology

New York, New York, 10003, United States

Location

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 24687404 BACKGROUND

MeSH Terms

Conditions

Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Syneron Medical

shlomitm@syneron-candela.com

+972-73-2442347

Study Officials

• Ruthie Amir, MD

  Syneron Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 21, 2016
• Study Start: January 13, 2017
• Primary Completion: May 3, 2018
• Study Completion: August 7, 2018
• Last Updated: April 18, 2019
• Results First Posted: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)