EMS for Abdominal and Gluteal Muscle Toning (CTP)

Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning

Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.

Study Overview

• Status: Completed
• Conditions: Non-Therapeutic Body Modification
• Intervention / Treatment: Device: The ZELTIQ EMS System

Detailed Description

The safety and effectiveness of an Electromagnetic Muscle Stimulation device when used for abdominal and gluteal toning will be evaluated in this study.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Marina Del Rey, California, United States, 90292
      • Marina Plastic Surgery
    • Pleasanton, California, United States, 94588
      • Innovation Research Center
    • San Diego, California, United States, 92121
      • Cosmetic Laser Dermatology
  • Florida
    • Miami, Florida, United States, 33133
      • Bowes Dermatology by Riverchase
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • The Wall Center for Plastic Surgery
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Capital Laser & Skin Care
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Skincare Physicians of Chestnut Hill
  • Texas
    • Dallas, Texas, United States, 75231
      • EpiCentre Park Lane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 refrain from any new abdominal and/or gluteal 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 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 not had an intrauterine contraceptive device inserted or removed within the past month.
• Subject has a bleeding disorder
• Subject is taking or has taken diet pills or supplements within the past month.
• Subject has a metal implant or active implanted device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system.
• Subject agrees not to change muscle exercise routine in the treatment area (abdominal and/or gluteal) while participating in the study
• 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 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 other investigational drug or device.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electromagnetic Muscle Stimulation Treatment Group - Abdomen; The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.	Device: The ZELTIQ EMS System; The Zeltiq EMS device will be used to perform treatments for abdominal and gluteal toning.
Experimental: Electromagnetic Muscle Stimulation Group - Abdomen and Buttocks; The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen and buttocks.	Device: The ZELTIQ EMS System; The Zeltiq EMS device will be used to perform treatments for abdominal and gluteal toning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Satisfaction Questionnaire From Baseline to 4-Week Post-Treatment Follow-up Visit	Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ)at the 4-Week 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 or buttocks). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 4-week post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.	Baseline, 4-week 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 12 weeks following the final treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS)	Subject-graded improvement in the treated area using the Subject Global Aesthetic Scale (SGAIS) at the 4-Week follow-up visit. In this study, subjects completed the SGAIS questionnaire for each treated area (e.g. a abdomen-specific questionnaire and a buttocks-specific questionnaire) at the 4-week post-final follow-up visit. Subjects were asked to rate improvement in treated areas using the following 7 point scale: 3 = Very much improved, 2 = Much improved, 1 = Improved, 0 = No change, -1 = Worse, -2 = Much worse and -3 = Very much worse. Subjects who reported 'Very Much Improved,' 'Much Improved,' and 'Improved will be categorized as 'Improved'. Results were calculated as the percentage of subjects reporting "Improved".	4-week post-treatment follow-up visit

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics
• Investigators: Study Director: Kerrie Jiang, NP, Zeltiq Aesthetics

Publications and helpful links

General Publications

• Fabi S, Dover JS, Tanzi E, Bowes LE, Tsai Fu F, Odusan A. A 12-Week, Prospective, Non-Comparative, Non-Randomized Study of Magnetic Muscle Stimulation for Improvement of Body Satisfaction With the Abdomen and Buttocks. Lasers Surg Med. 2021 Jan;53(1):79-88. doi: 10.1002/lsm.23348. Epub 2020 Nov 8.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: ZA19-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No