SlimShape Device for Abdominal Fat and Circumference Reduction

• Sponsor: Syneron Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02999763
• Collaborator: (none)
• Enrollment: 70
• Locations: 4
• Arm: 1
• Actual Duration (Months): 18.8
• Patients Per Site: 17.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: N/A
• 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
• Actual Study Start Date: Jan 13, 2017
• Actual Primary Completion Date: May 3, 2018
• Actual Study Completion Date: Aug 7, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Fat Thickness at Final Follow-up Compared to Baseline [Baseline and 12 weeks follow-up]

   Abdominal fat change, measured by ultrasound, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline

Secondary Outcome Measures

1. Change in Fat Thickness After Treatments Compared to Baseline [Baseline and 4 and 8 weeks follow-up]

   Abdominal fat change, measured by ultrasound, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline

2. Change in Abdominal Circumference After Treatments Compared to Baseline [At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment)]

   Change in abdominal circumference, measured by calibrated measuring tape, at 4, 8 and 12 weeks follow-up (after final treatment) compared to baseline

Other Outcome Measures

1. Number of Treatments Where Participants Reported Having "Mild", "Moderate" or "Severe" Response [First, second and third treatments, Weeks 0 to 4]

   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" )

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laser & Skin Surgery Medical Group, Inc	Sacramento	California	United States	95816
2	Syneron Candela Institute for Education Clinic	Wayland	Massachusetts	United States	01778
3	Union Square Laser Dermatology	New York	New York	United States	10003
4	Laser & Skin Surgery Center of New York	New York	New York	United States	10016

Sponsors and Collaborators

• Syneron Medical

Investigators

• Study Director: Ruthie Amir, MD, Syneron Medical

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 8, 2017

More Information

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.

• Responsible Party: Syneron Medical
• ClinicalTrials.gov Identifier: NCT02999763
• Other Study ID Numbers: DHF22621
• First Posted: Dec 21, 2016
• Last Update Posted: Apr 18, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Syneron Medical: lipolysis; fat reduction; circumference reduction
• Additional relevant MeSH terms: Lipid Metabolism Disorders

Study Results

Participant Flow

Arm/Group Title	Treated and Untreated Abdomen
Arm/Group Description	Circumference and fat thickness reduction of abdomen after SlimShape treatments (three treatments with SlimShape RF based device)
Period Title: Overall Study
STARTED	70
COMPLETED	58
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Treated and Untreated Abdomen
Arm/Group Description	Circumference and fat thickness measurements of abdomen before after SlimShape treatments of the same subjects
Overall Participants	70
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	70 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (9.6)
Sex: Female, Male (Count of Participants)
Female	68 97.1%
Male	2 2.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 5.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 5.7%
White	61 87.1%
More than one race	0 0%
Unknown or Not Reported	1 1.4%
Region of Enrollment (participants) [Number]
United States	70 100%
Fat Thickness (millimeter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeter]	22.83 (7.22)
Circumference (centimeter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter]	91.64 (7.82)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

58 participants analyzed at 12 week FU (12 subjects lost to follow-up at final visit)

Arm/Group Title	Treated Abdomen
Arm/Group Description	Subjects treated on the abdomen with SlimShape RF treatments
Measure Participants	58
Mean (Standard Deviation) [millimeters]	-1.76 (1.4)

2. Secondary Outcome

Title	Change in Fat Thickness After Treatments Compared to Baseline
Description	Abdominal fat change, measured by ultrasound, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline
Time Frame	Baseline and 4 and 8 weeks follow-up

Outcome Measure Data

Analysis Population Description

63 participants attended the 4 week FU (5 dropped and 2 missed the visit), 59 participants attended the 8 week FU (10 dropped and 1 missed the visit)

Arm/Group Title	Treated Abdomen
Arm/Group Description	Subjects treated on the abdomen with SlimShape RF treatments
Measure Participants	70
Fat thickness change at 4 week FU	-0.51 (2.2)
Fat thickness change at 8 week FU	-1.33 (2.3)

3. Secondary Outcome

Title	Change in Abdominal Circumference After Treatments Compared to Baseline
Description	Change in abdominal circumference, measured by calibrated measuring tape, at 4, 8 and 12 weeks follow-up (after final treatment) compared to baseline
Time Frame	At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment)

Outcome Measure Data

Analysis Population Description

63 participants attended the 4 week FU (5 dropped and 2 missed the visit), 59 participants attended the 8 week FU (10 dropped and 1 missed the visit), 58 participants attended the 12 week FU (12 Subjects dropped)

Arm/Group Title	Treated Abdomen
Arm/Group Description	Subjects treated on the abdomen with SlimShape RF treatments
Measure Participants	70
Abdominal circumference change at 4 week FU	-0.53 (2.6)
Abdominal circumference change at 8 week FU	-0.53 (2.6)
Abdominal circumference change at 12 week FU	-0.78 (2.7)

4. Other Pre-specified Outcome

Title	Number of Treatments Where Participants Reported Having "Mild", "Moderate" or "Severe" Response
Description	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" )
Time Frame	First, second and third treatments, Weeks 0 to 4

Outcome Measure Data

Analysis Population Description

70 participants attended the first treatment, 67 participants attended the second treatment (2 dropped and 1 missed treatment) and 65 participants attended the third treatment (3 dropped and 2 missed treatment), therefore overall 202 treatments conducted during the study.

Arm/Group Title	Treated Abdomen
Arm/Group Description	Subjects treated on the abdomen with SlimShape RF treatments
Measure Participants	70
Measure Overall Treatments	202
The rate of erythema after treatment	199
The rate of edema after treatment	84
The rate of hematoma / purpura after treatment	11
The rate of petechiae after treatment	35
The rate of pain after treatment	19

Adverse Events

Time Frame	Subjects were assessed and followed up for adverse events at each treatment (3 treatment at 2 weeks interval) and at 4 weeks, 8 weeks and 12 weeks after the SlimShape treatment
Arm/Group Title	Treated Abdomen
Arm/Group Description	Subjects treated on the abdomen with SlimShape RF treatments
All Cause Mortality
	Treated Abdomen
	Affected / at Risk (%)	# Events
Total	0/70 (0%)
Serious Adverse Events
	Treated Abdomen
	Affected / at Risk (%)	# Events
Total	0/70 (0%)
Other (Not Including Serious) Adverse Events
	Treated Abdomen
	Affected / at Risk (%)	# Events
Total	10/70 (14.3%)
Skin and subcutaneous tissue disorders
Blisters	7/70 (10%)	7
Vesicles	1/70 (1.4%)	2
Discoloration	1/70 (1.4%)	1
firm mass	1/70 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.