Muscle WeaknessMMSNCT04199312
Magnetic Muscle Stimulation of Abdominal Muscle
A study testing Magnetic Muscle Stimulation (MMS) device in people with Muscle Weakness, run by Zeltiq Aesthetics at 3 sites in United States.
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?
- Magnetic Muscle Stimulation (MMS) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Nov 2019to 29 Sep 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
- 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 have MRI during the scheduled time periods.
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- Subject agrees to refrain from any new abdominal 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 has had a non-invasive fat reduction procedure (e.g. CoolSculpting, SculpSure) in the area of intended treatment within the past 6 months.
- 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
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- 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
- 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 has any contraindications to MRI (e.g. metal implant, history of metal work or metal slivers in eye, prone to severe claustrophobia).
- 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
3 sites in 1 country.
United States3 sites
Innovation Research Center
Pleasanton, California, 94588
Laser and Skin Surgery Center of Northern California
Sacramento, California, 95816
Investigate MD
Scottsdale, Arizona, 85255
About this study
Evaluate the safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle.
- Conditions
- Muscle Weakness
- Being tested
- Magnetic Muscle Stimulation (MMS) device
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Muscle Stimulation (MMS) deviceDevice
The MMS device will be used to perform the treatments.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Magnetic Muscle Stimulation (MMS) | Experimental | Participants had a total of 4 MMS treatment sessions completed twice a week, within a 2-week period. Receives: Device: Magnetic Muscle Stimulation (MMS) device |
| Cohort 2: Magnetic Muscle Stimulation (MMS) | Experimental | Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period. Receives: Device: Magnetic Muscle Stimulation (MMS) device |
| Cohort 3: Magnetic Muscle Stimulation (MMS) | Experimental | Participants had 8 MMS treatments completed twice per week within a 4-week period. Receives: Device: Magnetic Muscle Stimulation (MMS) device |
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 Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.
Measured: AE information will be collected from the time of enrollment to the final follow-up visit at 3-months following the final treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start13 Nov 2019
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Why it stopped: Sponsor Discontinued due to business decision.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199312
- Sponsor's protocol ID
- ZA19-001
- Acronym
- MMS
- Status last verified
- Jun 2025
- First submitted
- 3 Dec 2019
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Muscle Stimulation of Abdominal Muscle
- ClinicalTrials.gov ID
- NCT04199312
- Acronym / sponsor ID
- MMS / ZA19-001
- Conditions
- Muscle Weakness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Discontinued due to business decision.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Posted 2 Jul 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Magnetic Muscle Stimulation (MMS) | Experimental | Device: Magnetic Muscle Stimulation (MMS) deviceParticipants had a total of 4 MMS treatment sessions completed twice a week, within a 2-week period. |
| Cohort 2: Magnetic Muscle Stimulation (MMS) | Experimental | Device: Magnetic Muscle Stimulation (MMS) deviceParticipants had 6 MMS treatment sessions completed twice a week, within a 3-week period. |
| Cohort 3: Magnetic Muscle Stimulation (MMS) | Experimental | Device: Magnetic Muscle Stimulation (MMS) deviceParticipants had 8 MMS treatments completed twice per week within a 4-week period. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 (23 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 has had a non-invasive fat reduction procedure (e.g. CoolSculpting, SculpSure) in the area of intended treatment within the past 6 months.
- 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.
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 |
|---|---|---|
| Magnetic Muscle Stimulation (MMS) deviceThe MMS device will be used to perform the treatments. | Device | Cohort 1: Magnetic Muscle Stimulation (MMS), Cohort 2: Magnetic Muscle Stimulation (MMS), Cohort 3: Magnetic Muscle Stimulation (MMS) |
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 Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
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.
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Muscle Stimulation (MMS) device in people with Muscle Weakness, run by Zeltiq Aesthetics at 3 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 9 inclusion and 23 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: stopped early, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 Jul 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?
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 2 Jul 2025.