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SlimShape Device for Abdominal Fat and Circumference Reduction

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ClinicalTrials.gov Identifier: NCT02999763
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

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.


Condition or disease Intervention/treatment Phase
Fat Disorder Device: SlimShape Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat and Circumference Reduction
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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




Primary Outcome Measures :
  1. Reduction in fat thickness at final follow-up compared to baseline [ Time Frame: Baseline and 12 weeks follow-up ]
    Abdominal fat reduction, measured by ultrasound and caliper, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline


Secondary Outcome Measures :
  1. Reduction in fat thickness after treatments compared to baseline [ Time Frame: Baseline and 4 and 8 weeks follow-up ]
    Abdominal fat reduction, measured by ultrasound and caliper, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline

  2. Reduction in abdominal circumference after treatments compared to baseline [ Time Frame: Baseline and at 4 weeks, 8 weeks and 12 weeks follow-up ]
    Reduction in abdominal circumference, measured by calibrated measuring tape, at 4 and 8 weeks follow-up after final treatment compared to baseline


Other Outcome Measures:
  1. Safety of SlimShape fat reduction treatments by adverse event reporting [ Time Frame: Baseline through study duration of 16 weeks ]
    Adverse event description, severity, intervention and outcome reporting



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999763


Contacts
Contact: Shlomit Mann, MSc shlomitm@syneron-candela.com

Locations
United States, California
Laser & Skin Surgery Medical Group, Inc Recruiting
Sacramento, California, United States, 95816
Contact    916-456-0400      
Principal Investigator: Suzanne Kilmer, MD         
United States, Massachusetts
Syneron Candela Institute for Education Clinic Recruiting
Wayland, Massachusetts, United States, 01778
Contact: Meghan Murphy, BSN    508-358-0359      
Principal Investigator: Konika Schallen, M.D.         
United States, New York
Union Square Laser Dermatology Recruiting
New York, New York, United States, 10003
Contact: Shannon Hernandez, BSN, RN    212-366-5400      
Principal Investigator: Anne M. Chapas, MD         
Laser & Skin Surgery Center of New York Recruiting
New York, New York, United States, 10016
Contact    212-686-7306      
Principal Investigator: Roy G. Geronemus, MD         
Sponsors and Collaborators
Syneron Medical
Investigators
Study Director: Ruthie Amir, MD Syneron Medical

Publications:
Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT02999763     History of Changes
Other Study ID Numbers: DHF22621
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Syneron Medical:
lipolysis
fat reduction
circumference reduction

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases