EMS for Abdominal and Gluteal Muscle Toning

NCT03983304 | Completed Results FDA Device

• 1 other identifier: ZA19-002
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 8

Brief Summary

Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.

Conditions

Non-Therapeutic Body Modification

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Percentage of Participants Reporting Improvement on the Subject Global Aesthetic Improvement Scale (SGAIS)

  4-week post-treatment follow-up visit

Study Arms (2)

Electromagnetic Muscle Stimulation Treatment Group - Abdomen

EXPERIMENTAL

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

Device: The ZELTIQ EMS System

Electromagnetic Muscle Stimulation Group - Abdomen and Buttocks

EXPERIMENTAL

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

Device: The ZELTIQ EMS System

Interventions

The ZELTIQ EMS System DEVICE

The Zeltiq EMS device will be used to perform treatments for abdominal and gluteal toning.

Electromagnetic Muscle Stimulation Group - Abdomen and Buttocks; Electromagnetic Muscle Stimulation Treatment Group - Abdomen

Eligibility Criteria

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

You may qualify if:

• 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.

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 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).

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (8)

Marina Plastic Surgery

Marina del Rey, California, 90292, United States

Location

Innovation Research Center

Pleasanton, California, 94588, United States

Location

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

Bowes Dermatology by Riverchase

Miami, Florida, 33133, United States

Location

The Wall Center for Plastic Surgery

Shreveport, Louisiana, 71105, United States

Location

Capital Laser & Skin Care

Chevy Chase, Maryland, 20815, United States

Location

SkinCare Physicians of Chestnut Hill

Chestnut Hill, Massachusetts, 02467, United States

Location

EpiCentre Park Lane

Dallas, Texas, 75231, United States

Location

Related Publications (1)

• 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.

  PMID: 33161584 RESULT

Results Point of Contact

• Title: Lori Brandt, Director, Clinical Trial Management
• Organization: Zeltiq Aesthetics

lori.brandt@abbvie.com

925 621-7460

Study Officials

• Kerrie Jiang, NP

  Zeltiq Aesthetics

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: May 10, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)