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CTP: EMS for Abdominal and Gluteal Muscle Toning

Sponsor
Zeltiq Aesthetics (Industry)
Overall Status
Completed
CT.gov ID
NCT03983304
Collaborator
(none)
110
Enrollment
8
Locations
1
Arm
11.7
Actual Duration (Months)
13.8
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.

Condition or Disease Intervention/Treatment Phase
  • Device: The ZELTIQ System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning
Actual Study Start Date :
May 10, 2019
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Efficacy Endpoint: Subject Satisfaction Questionnaire [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marina Plastic Surgery Marina Del Rey California United States 90292
2 Innovation Research Center Pleasanton California United States 94588
3 Cosmetic Laser Dermatology San Diego California United States 92121
4 Bowes Dermatology by Riverchase Miami Florida United States 33133
5 The Wall Center for Plastic Surgery Shreveport Louisiana United States 71105
6 Capital Laser & Skin Care Chevy Chase Maryland United States 20815
7 SkinCare Physicians of Chestnut Hill Chestnut Hill Massachusetts United States 02467
8 EpiCentre Park Lane Dallas Texas United States 75231

Sponsors and Collaborators

  • Zeltiq Aesthetics

Investigators

  • Study Director: Kerrie Jiang, NP, Zeltiq Aesthetics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT03983304
Other Study ID Numbers:
  • ZA19-002
First Posted:
Jun 12, 2019
Last Update Posted:
Sep 17, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Muscle Weakness

Study Results

No Results Posted as of Sep 17, 2021