Functional Change With MMS

NCT04506502 | Completed Results FDA Device

• 1 other identifier: ZA19-003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscle Weakness

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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).

Study Arms (1)

Muscle Toning

EXPERIMENTAL

The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.

Device: The ZELTIQ System

Interventions

The ZELTIQ System DEVICE

The MMS device will be used to perform the treatments.

Muscle Toning

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (1)

Innovation Research Center

Pleasanton, California, 94588, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Sally Hallas, RN, Director Clinical Development - Body Contouring
• Organization: Zeltiq Aesthetics

sally.hallas@abbvie.com

209-294-5571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: March 4, 2020
• Primary Completion: May 18, 2021
• Study Completion: July 6, 2021
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)