Fat DisorderNCT02999763

SlimShape Device for Abdominal Fat and Circumference Reduction

A study testing SlimShape in people with Fat Disorder, run by Syneron Medical at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Fat Disorder
What is being tested?: SlimShape
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 4 sitesUnited States
Study dates: 13 Jan 2017to 7 Aug 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

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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.

Who cannot join

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

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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
Obesity (BMI > 30)
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
Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).
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).
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Fat Disorder
Being tested: SlimShape
Keywords: lipolysis, fat reduction, circumference reduction
Medical subject headings: Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SlimShapeDevice
SlimShape radiofrequency treatment to the abdomen

Study groups in NCT02999763
Study group	Role	What they receive
Abdominal fat reduction treatment	Experimental	SlimShape treatments will be administered for up to 3 sessions to the abdomen of all study participants. Receives: Device: SlimShape

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline and 12 weeks follow-up

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 20177 Aug 2018

First posted21 Dec 2016 (estimated)
Study start13 Jan 2017
Primary completion3 May 2018
Study completion7 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Fat DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02999763
Sponsor's protocol ID: DHF22621
Status last verified: Apr 2019
First submitted: 19 Dec 2016
Last updated: 18 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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.
PubMed 24687404

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fat Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat and Circumference Reduction
ClinicalTrials.gov ID: NCT02999763
Acronym / sponsor ID: DHF22621
Conditions: Fat Disorder
Keywords: lipolysis, fat reduction, circumference reduction
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Syneron MedicalIndustry (pharma, biotech, devices)
Study start: 13 Jan 2017 (actual)
Primary completion: 3 May 2018 (actual)
Study completion: 7 Aug 2018 (actual)
First posted: 21 Dec 2016 (estimated)
Results: Posted 4 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Abdominal fat reduction treatment	Experimental	Device: SlimShapeSlimShape treatments will be administered for up to 3 sessions to the abdomen of all study participants.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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).

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SlimShapeSlimShape radiofrequency treatment to the abdomen	Device	Abdominal fat reduction treatment

Primary outcome

Change in Fat Thickness at Final Follow-up Compared to Baseline
Time frame: 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

2 secondary outcomes

Change in Fat Thickness After Treatments Compared to Baseline
Time frame: Baseline and 4 and 8 weeks follow-up
Change in Abdominal Circumference After Treatments Compared to Baseline
Time frame: At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment)

Results and safety

Results posted to the registry on 4 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treated and Untreated Abdomen	70	58

Primary outcome: Change in Fat Thickness at Final Follow-up Compared to Baseline

Time frame: Baseline and 12 weeks follow-up. Mean (Standard Deviation). Unit: millimeters

Measure	Treated Abdomen n = 58
Value	-1.76 (1.4)

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

2 secondary outcomes are reported in the full results.

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. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treated Abdomen	0 of 70 (0%)	10 of 70 (14.3%)	0 of 70

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24687404Adatto 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.
Individual participant dataSharing planned: No

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Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruiting
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RecruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ruthie Amir, MD study director

Syneron Medical

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SlimShape in people with Fat Disorder, run by Syneron Medical at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fat Thickness at Final Follow-up Compared to Baseline (time frame: Baseline and 12 weeks follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02999763, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.