Non-Therapeutic Body ModificationCTPNCT03983304

EMS for Abdominal and Gluteal Muscle Toning

A study testing The ZELTIQ EMS System in people with Non-Therapeutic Body Modification, run by Zeltiq Aesthetics at 8 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 for body contouring. Read more about this study

Who is it for?: Ages 22 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Non-Therapeutic Body Modification
What is being tested?: The ZELTIQ EMS System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 8 sitesUnited States
Study dates: 10 May 2019to 1 May 2020
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 or female ≥ 22 years and ≤65 years of age.
Subject has not had weight change exceeding 5% of body weight in the preceding month.
Subject agrees to maintain body weight within 5% during the study by not making any changes in diet or exercise routine.
Subject has a BMI ≤ 30 as determined at screening.
Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
Subject agrees to refrain from any new abdominal and/or gluteal muscle training exercises of the treatment area during the course of the study.
Subject agrees to avoid sun tanning during the course of the study.
Subject has read and signed the study written informed consent form.

Who cannot join

Subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process.
Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
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.
Subject has a bleeding disorder
Subject is taking or has taken diet pills or supplements within the past month.

Show all 19Show fewer

Subject has a metal implant or active implanted device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system.
Subject agrees not to change muscle exercise routine in the treatment area (abdominal and/or gluteal) while participating in the study
Subject has pulmonary insufficiency.
Subject has a cardiac disorder.
Subject has a malignant tumor.
Subject has been diagnosed with a seizure disorder such as epilepsy.
Subject currently has a fever.
Subject is diagnosed with Grave's disease.
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

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

SkinCare Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, 02467
Capital Laser & Skin Care
Chevy Chase, Maryland, 20815
EpiCentre Park Lane
Dallas, Texas, 75231
Marina Plastic Surgery
Marina del Rey, California, 90292
Bowes Dermatology by Riverchase
Miami, Florida, 33133
Innovation Research Center
Pleasanton, California, 94588
Cosmetic Laser Dermatology
San Diego, California, 92121
The Wall Center for Plastic Surgery
Shreveport, Louisiana, 71105

Other trials in United States

About this study

Official title: Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning

Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.

Read the detailed description

The safety and effectiveness of an Electromagnetic Muscle Stimulation device when used for abdominal and gluteal toning will be evaluated in this study.

Conditions: Non-Therapeutic Body Modification
Being tested: The ZELTIQ EMS System

What participants receive

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

The ZELTIQ EMS SystemDevice
The Zeltiq EMS device will be used to perform treatments for abdominal and gluteal toning.

Study groups in NCT03983304
Study group	Role	What they receive
Electromagnetic Muscle Stimulation Treatment Group - Abdomen	Experimental	The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen. Receives: Device: The ZELTIQ EMS System
Electromagnetic Muscle Stimulation Group - Abdomen and Buttocks	Experimental	The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen and buttocks. Receives: Device: The ZELTIQ EMS System

What is being measured

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

Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit
Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ)at the 4-Week post-treatment follow-up visit. The scale measures body image using a set of dichotomous items used to describe aspects of shape and appearance. The questionnaire has total score range from 10 to 50. An increase in score (when compared to baseline) reflects the participant's perceived improvement in appearance in the treated region(abdomen or buttocks). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 4-week post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.
Measured: Baseline, 4-week post-treatment follow-up visit
Number of Incidents of Device-Related Adverse Events
The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.
Measured: AE information will be collected from the time of enrollment to the final follow-up visit at 12 weeks following the final treatment.

Secondary outcomes (1)

Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS)
Subject-graded improvement in the treated area using the Subject Global Aesthetic Scale (SGAIS) at the 4-Week follow-up visit. In this study, subjects completed the SGAIS questionnaire for each treated area (e.g. a abdomen-specific questionnaire and a buttocks-specific questionnaire) at the 4-week post-final follow-up visit. Subjects were asked to rate improvement in treated areas using the following 7 point scale:
3 = Very much improved, 2 = Much improved, 1 = Improved, 0 = No change, -1 = Worse, -2 = Much worse and -3 = Very much worse. Subjects who reported 'Very Much Improved,' 'Much Improved,' and 'Improved will be categorized as 'Improved'. Results were calculated as the percentage of subjects reporting "Improved".
Measured: 4-week post-treatment follow-up visit

Timeline

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

10 May 20191 May 2020

First posted12 Jun 2019
Study start10 May 2019
Primary completion1 May 2020
Study completion1 May 2020

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 Non-Therapeutic Body ModificationStudies 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: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03983304
Sponsor's protocol ID: ZA19-002
Acronym: CTP
Status last verified: May 2025
First submitted: 10 Jun 2019
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

Fabi S, Dover JS, Tanzi E, Bowes LE, Tsai Fu F, Odusan A. A 12-Week, Prospective, Non-Comparative, Non-Randomized Study of Magnetic Muscle Stimulation for Improvement of Body Satisfaction With the Abdomen and Buttocks. Lasers Surg Med. 2021 Jan;53(1):79-88. doi: 10.1002/lsm.23348. Epub 2020 Nov 8.
PubMed 33161584

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: Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning
ClinicalTrials.gov ID: NCT03983304
Acronym / sponsor ID: CTP / ZA19-002
Conditions: Non-Therapeutic Body Modification
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: 10 May 2019 (actual)
Primary completion: 1 May 2020 (actual)
Study completion: 1 May 2020 (actual)
First posted: 12 Jun 2019 (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 for body contouring.

Detailed description

The safety and effectiveness of an Electromagnetic Muscle Stimulation device when used for abdominal and gluteal toning will be evaluated in this study.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Electromagnetic Muscle Stimulation Treatment Group - Abdomen	Experimental	Device: The ZELTIQ EMS SystemThe treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.
Electromagnetic Muscle Stimulation Group - Abdomen and Buttocks	Experimental	Device: The ZELTIQ EMS SystemThe treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen and buttocks.

Who may qualify

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

Key inclusion criteria (8 listed)

Male or female ≥ 22 years and ≤65 years of age.
Subject has not had weight change exceeding 5% of body weight in the preceding month.
Subject agrees to maintain body weight within 5% during the study by not making any changes in diet or exercise routine.
Subject has a BMI ≤ 30 as determined at screening.
Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.

Key exclusion criteria (19 listed)

Subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process.
Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
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.
Subject has a bleeding disorder

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
The ZELTIQ EMS SystemThe Zeltiq EMS device will be used to perform treatments for abdominal and gluteal toning.	Device	Electromagnetic Muscle Stimulation Group - Abdomen and Buttocks, Electromagnetic Muscle Stimulation Treatment Group - Abdomen

Primary outcome

Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit
Time frame: Baseline, 4-week post-treatment follow-up visit
Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ)at the 4-Week post-treatment follow-up visit. The scale measures body image using a set of dichotomous items used to describe aspects of shape and appearance. The questionnaire has total score range from 10 to 50. An increase in score (when compared to baseline) reflects the participant's perceived improvement in appearance in the treated region(abdomen or buttocks). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 4-week post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.
Number of Incidents of Device-Related Adverse Events
Time frame: AE information will be collected from the time of enrollment to the final follow-up visit at 12 weeks following the final treatment.
The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.

1 secondary outcome

Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS)
Time frame: 4-week post-treatment 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
EMS Device Treatment Group	110	103

Primary outcome: Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit

Time frame: Baseline, 4-week post-treatment follow-up visit. Mean (Standard Deviation). Unit: Participants completed Questionnaire

Measure	EMS Device Treatment - Abdomen n = 92	EMS Treatment - Buttocks n = 32
Value	5.1 (5.4)	5.5 (5.3)

Population analysed: Per-protocol population. Participants with completed questionnaires specific to each body area treated.

Primary outcome: Number of Incidents of Device-Related Adverse Events

Time frame: AE information will be collected from the time of enrollment to the final follow-up visit at 12 weeks following the final treatment.. Number. Unit: Device-Related Adverse Events

Measure	EMS Device Treatment Group n = 110
Value	6

Population analysed: All participants enrolled in the study and treated with the EMS device were evaluated for adverse events throughout the study. Investigators determined if an AE was not related, possibly related, probably related or definitely related to the study device. Data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the time of enrollment through the 12-week post-treatment follow-up visit, approximately 4 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EMS Device Treatment Group	1 of 110 (0.9%)	11 of 110 (10%)	0 of 110

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 33161584Fabi S, Dover JS, Tanzi E, Bowes LE, Tsai Fu F, Odusan A. A 12-Week, Prospective, Non-Comparative, Non-Randomized Study of Magnetic Muscle Stimulation for Improvement of Body Satisfaction With the Abdomen and Buttocks. Lasers Surg Med. 2021 Jan;53(1):79-88. doi: 10.1002/lsm.23348. Epub 2020 Nov 8.
Individual participant dataSharing planned: No

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

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

Questions about this trial

What is this clinical trial studying?

A study testing The ZELTIQ EMS System in people with Non-Therapeutic Body Modification, run by Zeltiq Aesthetics at 8 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 8 inclusion and 19 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 8 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?

Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit (time frame: Baseline, 4-week post-treatment 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 NCT03983304, 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; AzTrials last refreshed its copy on 7 Nov 2026.