Magnetic Muscle Stimulation of Abdominal Muscle (MMS)

Zeltiq Aesthetics

Status: Terminated

Conditions: Muscle Weakness

Treatments: Device: Magnetic Muscle Stimulation (MMS) device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04199312

ZA19-001

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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
• 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 design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

Cohort 1: Magnetic Muscle Stimulation (MMS)

Experimental group

Description:

Participants had a total of 4 MMS treatment sessions completed twice a week, within a 2-week period.

Treatment:

Device: Magnetic Muscle Stimulation (MMS) device

Cohort 2: Magnetic Muscle Stimulation (MMS)

Experimental group

Description:

Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period.

Treatment:

Device: Magnetic Muscle Stimulation (MMS) device

Cohort 3: Magnetic Muscle Stimulation (MMS)

Experimental group

Description:

Participants had 8 MMS treatments completed twice per week within a 4-week period.

Treatment:

Device: Magnetic Muscle Stimulation (MMS) device