Muscle WeaknessFMSNCT04506502

Functional Change With MMS

A study testing The ZELTIQ System in people with Muscle Weakness, run by Zeltiq Aesthetics at 1 site 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 safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle. Read more about this study

Who is it for?: Ages 22 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Muscle Weakness
What is being tested?: The ZELTIQ System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 4 Mar 2020to 6 Jul 2021
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

Subject (healthy volunteer) has read and signed the study written informed consent form.
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 during the course of the study.
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 muscle training exercises of the treatment area during the course of the study.

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 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 had an intrauterine contraceptive device inserted or removed within the past month.
Subject has a bleeding disorder or hemorrhagic condition
Subject is taking or has taken diet pills or supplements within the past month.
Subject has an active implanted electrical device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system.

Show all 20Show fewer

Subject has metal or electronic implants in or adjacent to the treatment area
Subject has an abdominal hernia.
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 has a growth plate in the treatment area
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 unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
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

1 site in 1 country.

United States1 site

Innovation Research Center
Pleasanton, California, 94588

Other trials in United States

About this study

Official title: Functional Changes With Magnetic Muscle Stimulation of Abdominal Muscle

Evaluate the safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle.

Conditions: Muscle Weakness
Being tested: The ZELTIQ System
Medical subject headings: Muscle Weakness

What participants receive

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

The ZELTIQ SystemDevice
The MMS device will be used to perform the treatments.

Study groups in NCT04506502
Study group	Role	What they receive
Muscle Toning	Experimental	The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen. Receives: Device: The ZELTIQ 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 1-month Post-Treatment Follow-up Visit
Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ) at the 1-month 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). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 1-month post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.
Measured: Baseline, 1-month 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 3-months following the final treatment (approximately 4 months).

Timeline

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

4 Mar 20206 Jul 2021

First posted10 Aug 2020
Study start4 Mar 2020
Primary completion18 May 2021
Study completion6 Jul 2021

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.
Other trials for Muscle WeaknessStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04506502
Sponsor's protocol ID: ZA19-003
Acronym: FMS
Status last verified: Apr 2025
First submitted: 6 Aug 2020
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

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 Muscle Weakness trials

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: Functional Changes With Magnetic Muscle Stimulation of Abdominal Muscle
ClinicalTrials.gov ID: NCT04506502
Acronym / sponsor ID: FMS / ZA19-003
Conditions: Muscle Weakness
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: 4 Mar 2020 (actual)
Primary completion: 18 May 2021 (actual)
Study completion: 6 Jul 2021 (actual)
First posted: 10 Aug 2020 (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 safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle.

Study design

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

Arm	Type	Receives
Muscle Toning	Experimental	Device: The ZELTIQ SystemThe treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.

Who may qualify

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

Key inclusion criteria (7 listed)

Subject (healthy volunteer) has read and signed the study written informed consent form.
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 during the course of the study.
Subject has a BMI ≤ 30 as determined at screening.

Key exclusion criteria (20 listed)

Subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process.
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 had an intrauterine contraceptive device inserted or removed within the past month.
Subject has a bleeding disorder or hemorrhagic condition
Subject is taking or has taken diet pills or supplements 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
The ZELTIQ SystemThe MMS device will be used to perform the treatments.	Device	Muscle Toning

Primary outcome

Change in Body Satisfaction Questionnaire From Baseline to 1-month Post-Treatment Follow-up Visit
Time frame: Baseline, 1-month post-treatment follow-up visit
Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ) at the 1-month 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). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 1-month 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 3-months following the final treatment (approximately 4 months).
The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.

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
Magnetic Muscle Stimulation (MMS) Treatment Group	16	14

Primary outcome: Change in Body Satisfaction Questionnaire From Baseline to 1-month Post-Treatment Follow-up Visit

Time frame: Baseline, 1-month post-treatment follow-up visit. Mean (Standard Deviation). Unit: units on a scale

Measure	Magnetic Muscle Stimulation (MMS) Treatment Group n = 14
Value	8.6 (5.4)

Population analysed: Two subjects were excluded from per protocol population due to incomplete treatments and withdrawal of consent. The Per Protocol population consisted of all treated subjects that received 8 MMS treatments and with a weight change of no more than 5% of total body weight at the time the 1-month assessments were performed compared to the weight obtained at the first treatment visit.

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 3-months following the final treatment (approximately 4 months).. Number. Unit: Device-Related Adverse Events

Measure	Magnetic Muscle Stimulation (MMS) Treatment Group n = 16
Value	1

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).

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Magnetic Muscle Stimulation (MMS) Treatment Group	0 of 16 (0%)	6 of 16 (37.5%)	0 of 16

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.
Individual participant dataSharing planned: No

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Active, not recruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing The ZELTIQ System in people with Muscle Weakness, run by Zeltiq Aesthetics at 1 site 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 7 inclusion and 20 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 1 site 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 1-month Post-Treatment Follow-up Visit (time frame: Baseline, 1-month 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 NCT04506502.

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.