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: Muscle Weakness
• Intervention / Treatment: Device: The ZELTIQ System

• 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: No
• Genders Eligible for Study: All

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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Muscle Toning; The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen and buttocks.	Device: The ZELTIQ System; The EMS device will be used to perform the treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

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): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

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