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OpenTrials
Completed

NCT Number: NCT04506502

Functional Change With MMS

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

Completed

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Key information

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Innovation Research Center

Pleasanton, California, 94588, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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 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.

Treatment and study plan

The ZELTIQ System

Device

The MMS device will be used to perform the treatments.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Zeltiq Aesthetics

Industry

Registry information

Official study title

Functional Changes With Magnetic Muscle Stimulation of Abdominal Muscle

Acronym: FMS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 10, 2020
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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