EMS for Abdominal and Gluteal Muscle Toning

Muscle Weakness Clinical Trial

— CTP  

Official title:

Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03983304
• Other study ID #: ZA19-002
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: September 2021
• Source: Zeltiq Aesthetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness

Intervention

Device:
• The ZELTIQ System
The EMS device will be used to perform the treatments.

Locations

Country	Name	City	State
United States	SkinCare Physicians of Chestnut Hill	Chestnut Hill	Massachusetts
United States	Capital Laser & Skin Care	Chevy Chase	Maryland
United States	EpiCentre Park Lane	Dallas	Texas
United States	Marina Plastic Surgery	Marina Del Rey	California
United States	Bowes Dermatology by Riverchase	Miami	Florida
United States	Innovation Research Center	Pleasanton	California
United States	Cosmetic Laser Dermatology	San Diego	California
United States	The Wall Center for Plastic Surgery	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Zeltiq Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Endpoint: Subject Satisfaction Questionnaire	Measurement of subject feeling about body shape, assessed using the Body Satisfaction Scale at the 4-Week follow-up visit.	4-wk follow up visit
Secondary	Subject Global Aesthetic Improvement Scale (GAIS)	Subject-graded improvement in the treated area using the Subject Global Aesthetic Scale (SGAIS) at the 4-Week follow-up visit.	4-wk follow up visit