Clinical trial NCT02999763: SlimShape Device for Abdominal Fat and Circumference Reduction
Official title: Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat and Circumference Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Disorder
Keywords: lipolysis
fat reduction
circumference reduction
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2016-12-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Fat Thickness at Final Follow-up Compared to Baseline
timeFrame: Baseline and 12 weeks follow-up
Secondary outcomes:
measure: Change in Fat Thickness After Treatments Compared to Baseline
timeFrame: Baseline and 4 and 8 weeks follow-up
measure: Change in Abdominal Circumference After Treatments Compared to Baseline
timeFrame: At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment)
Other outcomes:
measure: Number of Treatments Where Participants Reported Having "Mild", "Moderate" or "Severe" Response
timeFrame: First, second and third treatments, Weeks 0 to 4
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Surgery Medical Group, Inc
state: California
city: Wayland
country: United States
facility: Syneron Candela Institute for Education Clinic
state: Massachusetts
city: New York
country: United States
facility: Union Square Laser Dermatology
state: New York
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York
state: New York
Study officials:
affiliation: Syneron Medical
name: Ruthie Amir, MD
role: STUDY_DIRECTOR
References:
citation: 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.