Body Fat DisorderECANCT03738891

CoolSculpting and EMS for the Abdomen

A study testing Zeltiq CoolSculpting System alone, Electromagnetic Muscle Stimulation alone and EMS followed by CoolSculping in people with Body Fat Disorder, run by Zeltiq Aesthetics at 4 sites in United States.

Completed

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

Official record

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Trial summary

Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting. Read more about this study

Who is it for?: Ages 22 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Body Fat Disorder
What is being tested?: Zeltiq CoolSculpting System alone, Electromagnetic Muscle Stimulation alone and EMS followed by CoolSculping
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 4 sitesUnited States
Study dates: 7 Nov 2018to 9 Sep 2019
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 22 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female subjects > 22 years of age and ≤65 years of age.
Subject has not had weight change exceeding 5% of body weight in the preceding month.
Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
Subject agrees to refrain from any new abdominal training exercises during the course of the study.
BMI ≤ 30 kg/m^2 as determined at screening.
Abdominal skin fold thickness 2.0 to 5.0 cm, as measured by caliper below umbilicus.
Cohort 4 only: Subject participated in protocol ZA18-003 in Cohort 3, and received the CoolSculpting treatment no more than 6 months prior.
Subject has read and signed a written informed consent form.

Who cannot join

Subject has had a surgical procedure(s) in the area of intended treatment.
Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
Subject has had a non-invasive fat reduction, body contouring and/or skin tightening procedure in the area of intended treatment within the past 12 months.
Subject has numbness, tingling or other altered sensation in the treatment area.
Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
Subject has not had an intrauterine contraceptive device inserted or removed within the past month.

Show all 24Show fewer

Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria
Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
Subject has a history of bleeding disorder or is taking any medication that in the Investigator's opinion may increase the subject's risk of bruising.
Subject has known sensitivity or allergy to isopropyl alcohol and propylene glycol, or latex.
Subject is taking or has taken diet pills or supplements within the past month.
Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites, that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
Subject has a metal implant or active implanted device such as a pacemaker, defibrillator, or drug delivery system.
Subject has been involved in any type of abdominal muscle training program within the previous 6 months.
Subject has pulmonary insufficiency.
Subject has a cardiac disorder.
Subject has a malignant tumor.
Subject has been diagnosed with epilepsy.
Subject currently has a fever.
Subject is pregnant or intending to become pregnant during the study period (in the next 9 months).
Subject is lactating or has been lactating in the past 6 months.
Subject is unable or unwilling to comply with the study requirements.
Subject is currently enrolled in a clinical study of any other investigational drug or device.
Any other condition or laboratory value that would, in the professional opinion of the Investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Aesthetic Solutions, P.A.
Chapel Hill, North Carolina, 27517
Marina Plastic Surgery
Marina del Rey, California, 90292
Innovation Research Center
Pleasanton, California, 94588
Laser & Skin Surgery Center of Northern California
Sacramento, California, 95816

Other trials in United States

About this study

Official title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for Abdominal Contouring

Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.

Conditions: Body Fat Disorder
Being tested: Zeltiq CoolSculpting System alone, Electromagnetic Muscle Stimulation alone, EMS followed by CoolSculping, CoolSculpting followed by EMS

What participants receive

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

Zeltiq CoolSculpting System aloneDevice
Also called CoolSculpting
The CoolSculpting System will be used to perform the treatments in Cohort 3.
Electromagnetic Muscle Stimulation aloneDevice
Also called EMS
The EMS device(s) alone are used in Cohort 1.
EMS followed by CoolSculpingDevice
Cohort 2 group will be treated with EMS followed by CoolSculpting
CoolSculpting followed by EMSDevice
Cohort 4 will be treated first with CoolSculpting, followed by EMS.

Study groups in NCT03738891
Study group	Role	What they receive
Electromagnetic Muscle Stimulation (EMS) only - Cohort 1	Experimental	Subjects in this group will be treated with 4 sessions of EMS. CoolSculpting will not be used. Receives: Device: Electromagnetic Muscle Stimulation alone
Electromagnetic Muscle Stimulation (EMS) followed by CoolSculpting- Cohort 2	Experimental	Following 4 sessions of EMS, subjects will receive 3-6 cycles of CoolSculpting. Receives: Device: EMS followed by CoolSculping
CoolSculpting only - Cohort 3	Experimental	Subjects in this arm will receive 3-6 cycles of CoolSculpting treatments. Receives: Device: Zeltiq CoolSculpting System alone
CoolSculpting followed by Electromagnetic Muscle Stimulation (EMS )- Cohort 4	Experimental	Subjects in this group will have 3-6 cycles of CoolSculpting followed by 4 EMS sessions. Receives: Device: CoolSculpting followed by EMS

What is being measured

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

Number of Unanticipated Adverse Device Effects (UADE)
The number of UADEs occurring during the study will be tabulated.
Measured: Enrollment through the final 12-week follow-up visit.
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
Comparison of pre-treatment- and 12-week post-final treatment photographs by independent physician reviewer. The reviewer was blinded to the method of treatment and study cohort; baseline and 12-week post-treatment photos were not blinded. After Sponsor training, the reviewer entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").
Measured: Baseline photos will be compared to images collected at the final 12-week post-treatment follow-up visit.

Secondary outcomes (2)

Change in Pre-treatment and Post-treatment Abdominal Circumference
Abdominal circumference as measured by 3-Dimensional imaging prior to treatment (baseline) is compared to images collected at the final 12-week post-treatment follow-up visit. Measurements were captured at 3 points including the upper, middle and lower abdomen. All measurements were averaged per subject at the baseline and 12-week visit time points to obtain circumference values. Results for each cohort are shown in millimeters of circumference reduction.
Measured: Baseline and final 12-week follow-up visit.
Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement
Subjects completed a graded 7-point GAIS at 12-week post-final treatment follow-up. The scale consists of the following response options: 3 = Very much improved; 2 = Much improved; 1 = Improved; 0 = No change; -1 = Worse; -2 = Much worse; -3 = Very much worse. Results were tabulated across the three treatment cohorts. Results were calculated in the percentage of the subjects reporting improvement.
Measured: Final post-treatment 12-week follow-up visit

Timeline

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

7 Nov 20189 Sep 2019

First posted13 Nov 2018
Study start7 Nov 2018
Primary completion9 Sep 2019
Study completion9 Sep 2019

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 Body 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: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03738891
Sponsor's protocol ID: ZA18-003
Acronym: ECA
Status last verified: May 2025
First submitted: 8 Nov 2018
Last updated: 16 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Kilmer SL, Cox SE, Zelickson BD, Bachelor EP, Gamio S, Ostrowski R, Pham LD, Stevens WG. Feasibility Study of Electromagnetic Muscle Stimulation and Cryolipolysis for Abdominal Contouring. Dermatol Surg. 2020 Oct;46 Suppl 1(1):S14-S21. doi: 10.1097/DSS.0000000000002420.
PubMed 32976168

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?

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for Abdominal Contouring
ClinicalTrials.gov ID: NCT03738891
Acronym / sponsor ID: ECA / ZA18-003
Conditions: Body Fat Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: 7 Nov 2018 (actual)
Primary completion: 9 Sep 2019 (actual)
Study completion: 9 Sep 2019 (actual)
First posted: 13 Nov 2018 (actual)
Results: Posted 16 May 2025

Clinical summary

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

Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Electromagnetic Muscle Stimulation (EMS) only - Cohort 1	Experimental	Device: Electromagnetic Muscle Stimulation aloneSubjects in this group will be treated with 4 sessions of EMS. CoolSculpting will not be used.
Electromagnetic Muscle Stimulation (EMS) followed by CoolSculpting- Cohort 2	Experimental	Device: EMS followed by CoolSculpingFollowing 4 sessions of EMS, subjects will receive 3-6 cycles of CoolSculpting.
CoolSculpting only - Cohort 3	Experimental	Device: Zeltiq CoolSculpting System aloneSubjects in this arm will receive 3-6 cycles of CoolSculpting treatments.
CoolSculpting followed by Electromagnetic Muscle Stimulation (EMS )- Cohort 4	Experimental	Device: CoolSculpting followed by EMSSubjects in this group will have 3-6 cycles of CoolSculpting followed by 4 EMS sessions.

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male and female subjects > 22 years of age and ≤65 years of age.
Subject has not had weight change exceeding 5% of body weight in the preceding month.
Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
Subject agrees to refrain from any new abdominal training exercises during the course of the study.
BMI ≤ 30 kg/m^2 as determined at screening.

Key exclusion criteria (24 listed)

Subject has had a surgical procedure(s) in the area of intended treatment.
Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
Subject has had a non-invasive fat reduction, body contouring and/or skin tightening procedure in the area of intended treatment within the past 12 months.
Subject has numbness, tingling or other altered sensation in the treatment area.
Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.

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
Zeltiq CoolSculpting System aloneAlso: CoolSculptingThe CoolSculpting System will be used to perform the treatments in Cohort 3.	Device	CoolSculpting only - Cohort 3
Electromagnetic Muscle Stimulation aloneAlso: EMSThe EMS device(s) alone are used in Cohort 1.	Device	Electromagnetic Muscle Stimulation (EMS) only - Cohort 1
EMS followed by CoolSculpingCohort 2 group will be treated with EMS followed by CoolSculpting	Device	Electromagnetic Muscle Stimulation (EMS) followed by CoolSculpting- Cohort 2
CoolSculpting followed by EMSCohort 4 will be treated first with CoolSculpting, followed by EMS.	Device	CoolSculpting followed by Electromagnetic Muscle Stimulation (EMS )- Cohort 4

Primary outcome

Number of Unanticipated Adverse Device Effects (UADE)
Time frame: Enrollment through the final 12-week follow-up visit.
The number of UADEs occurring during the study will be tabulated.
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
Time frame: Baseline photos will be compared to images collected at the final 12-week post-treatment follow-up visit.
Comparison of pre-treatment- and 12-week post-final treatment photographs by independent physician reviewer. The reviewer was blinded to the method of treatment and study cohort; baseline and 12-week post-treatment photos were not blinded. After Sponsor training, the reviewer entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").

2 secondary outcomes

Change in Pre-treatment and Post-treatment Abdominal Circumference
Time frame: Baseline and final 12-week follow-up visit.
Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement
Time frame: Final post-treatment 12-week follow-up visit

Results and safety

Results posted to the registry on 16 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1-EMS Only	20	20
Cohort 2 - EMS Followed by CoolSculpting	20	20
Cohort 3 - CoolSculpting Only	10	10
Cohort 4	0	0

Primary outcome: Number of Unanticipated Adverse Device Effects (UADE)

Time frame: Enrollment through the final 12-week follow-up visit.. Number. Unit: events

Measure	Cohort 1-EMS Only n = 20	Cohort 2 - EMS and CoolSculpting n = 20	Cohort 3 - CoolSculpting Only n = 10	Cohort 4 - CoolSculpting Followed by EMS n = 1
Value	0	0	0	0

Population analysed: All Participants who received at least one study treatment. Participants in all cohorts were evaluated for adverse events.

Primary outcome: Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)

Time frame: Baseline photos will be compared to images collected at the final 12-week post-treatment follow-up visit.. Count of participants. Unit: Participants

Measure	Cohort 1-EMS Only n = 20	Cohort 2 - EMS Followed by CoolSculpting n = 18	Cohort 3 - CoolSculpting Only n = 9
Value	16	16	8

Population analysed: All enrolled participants in Cohort 1 were included in the efficacy analysis. Cohort 2 excluded 1 participant for weight outside of protocol requirements and 1 subject for lack of 12-week follow-up photos. Cohort 3 excluded 1 participant due to a surgical procedure in the treatment area. Cohort 4 excluded one participant previously enrolled and treated in Cohort 3 (allowed per protocol); participant included in Cohort 3 analysis only.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event information was collected from the time of enrollment through the final 12-week follow-up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1-EMS Only	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Cohort 2 - EMS Followed by CoolSculpting	0 of 20 (0%)	2 of 20 (10%)	0 of 20
Cohort 3 - CoolSculpting Only	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Cohort 4 - CoolSculpting Followed by EMS	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32976168Kilmer SL, Cox SE, Zelickson BD, Bachelor EP, Gamio S, Ostrowski R, Pham LD, Stevens WG. Feasibility Study of Electromagnetic Muscle Stimulation and Cryolipolysis for Abdominal Contouring. Dermatol Surg. 2020 Oct;46 Suppl 1(1):S14-S21. doi: 10.1097/DSS.0000000000002420.
Individual participant dataSharing planned: No

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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.

Kerrie Jiang, NP study director

Zeltiq Aesthetics

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

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 24 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 16 May 2025. 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 16 May 2025). 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?

Number of Unanticipated Adverse Device Effects (UADE) (time frame: Enrollment through the final 12-week follow-up visit.). The study lists 2 primary outcomes in all. 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 NCT03738891, 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 16 May 2025.