EMS for Abdominal and Gluteal Muscle Toning

NCT ID: NCT03983304

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-10
• Study Completion Date: 2020-05-01

Brief Summary

Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.

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.

Conditions

Non-Therapeutic Body Modification

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Electromagnetic Muscle Stimulation Treatment Group - Abdomen

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

Group Type: EXPERIMENTAL

The ZELTIQ EMS System

Intervention Type: DEVICE

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

Electromagnetic Muscle Stimulation Group - Abdomen and Buttocks

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

Group Type: EXPERIMENTAL

The ZELTIQ EMS System

Intervention Type: DEVICE

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

Interventions

The ZELTIQ EMS System

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

Intervention Type: DEVICE

Eligibility 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 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zeltiq Aesthetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerrie Jiang, NP

Role: STUDY_DIRECTOR

Zeltiq Aesthetics

Locations

Marina Plastic Surgery

Marina del Rey, California, United States

Innovation Research Center

Pleasanton, California, United States

Cosmetic Laser Dermatology

San Diego, California, United States

Bowes Dermatology by Riverchase

Miami, Florida, United States

The Wall Center for Plastic Surgery

Shreveport, Louisiana, United States

Capital Laser & Skin Care

Chevy Chase, Maryland, United States

SkinCare Physicians of Chestnut Hill

Chestnut Hill, Massachusetts, United States

EpiCentre Park Lane

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 33161584 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ZA19-002

Identifier Type: -

Identifier Source: org_study_id