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EMS for Abdominal and Gluteal Muscle Toning (CTP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03983304
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics

Brief Summary:
Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.

Condition or disease Intervention/treatment Phase
Body Fat Disorder Device: The ZELTIQ System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning
Estimated Study Start Date : June 10, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Experimental: Fat Reduction
The treatments are designed to see if the fat can be toned in the abdomen and the glute.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.




Primary Outcome Measures :
  1. Efficacy Endpoint: Subject Satisfaction Questionnaire [ Time Frame: 4-wk follow up visit ]
    Measurement of subject feeling about body shape, assessed using the Body Satisfaction Scale at the 4-Week follow-up visit.


Secondary Outcome Measures :
  1. Subject Global Aesthetic Improvement Scale (GAIS) [ Time Frame: 4-wk follow up visit ]
    Subject-graded improvement in the treated area using the Subject Global Aesthetic Scale (SGAIS) at the 4-Week follow-up visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983304


Contacts
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Contact: Tonia N Madere 925-474-2537 tonia.madere@allergan.com

Locations
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United States, California
Innovation Research Center Active, not recruiting
Pleasanton, California, United States, 94588
Cosmetic Laser Dermatology Active, not recruiting
San Diego, California, United States, 92121
United States, Florida
Bowes Dermatology by Riverchase Recruiting
Miami, Florida, United States, 33133
Contact: Elizabeth DeKok    305-856-6519    edekok@riverchasederm.com   
Contact: Carla Homez    (305) 856 6519    chomez@riverchasederm.com   
Principal Investigator: Leyda Bowes, MD         
Sponsors and Collaborators
Zeltiq Aesthetics
Investigators
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Study Director: Kerrie Jiang, NP Zeltiq Aesthetics

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Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT03983304     History of Changes
Other Study ID Numbers: ZA19-002
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases