CoolSculpting and EMS for the Abdomen

Body Fat Disorder Clinical Trial

— ECA  

Official title:

A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for Abdominal Contouring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738891
• Other study ID #: ZA18-003
• Status: Completed
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: September 9, 2019

Study information

• Verified date: August 2020
• Source: Zeltiq Aesthetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 9, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria

• Male and female subjects > 22 years of age and =65 years of age.

• Subject has not had weight change exceeding 5% of body weight in the preceding month.

• Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.

• Subject agrees to refrain from any new abdominal training exercises during the course of the study.

• BMI = 30 kg/m2 as determined at screening.

• Abdominal skin fold thickness 2.0 to 5.0 cm, as measured by caliper below umbilicus.

• Subject has read and signed a written informed consent form.

Exclusion Criteria

• Subject has had a surgical procedure(s) in the area of intended treatment.

• Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.

• Subject has had a non-invasive fat reduction, body contouring and/or skin tightening procedure in the area of intended treatment within the past 12 months.

• Subject has numbness, tingling or other altered sensation in the treatment area.

• 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 known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria

• Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.

• Subject has a history of bleeding disorder or is taking any medication that in the Investigator's opinion may increase the subject's risk of bruising.

• Subject has known sensitivity or allergy to isopropyl alcohol and propylene glycol, or latex.

• Subject is taking or has taken diet pills or supplements within the past month.

• Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites, that may interfere with the treatment or evaluation (stretch marks is not an exclusion).

• Subject has a metal implant or active implanted device such as a pacemaker, defibrillator, or drug delivery system.

• Subject has been involved in any type of abdominal muscle training program within the previous 6 months.

• Subject has pulmonary insufficiency.

• Subject has a cardiac disorder.

• Subject has a malignant tumor.

• Subject has been diagnosed with epilepsy.

• Subject currently has a fever.

• 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

• Body Fat Disorder
• Lipid Metabolism Disorders

Intervention

Device:
• The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.

Locations

Country	Name	City	State
United States	Aesthetic Solutions, P.A.	Chapel Hill	North Carolina
United States	Marina Plastic Surgery	Marina Del Rey	California
United States	Innovation Research Center	Pleasanton	California
United States	Laser & Skin Surgery Center of Northern California	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Zeltiq Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety endpoint in relation to adverse events	Measurement of device- or procedure-related adverse events.	Final post treatment 1 day visit
Primary	Effectiveness endpoint gauged by photographs	Comparison of pre-treatment- and 12-week post-final treatment photographs to assess visible changes in the abdomen.	Final post treatment 1 day visit
Secondary	3-D imaging	Reduction in abdominal circumference as measured by 3-Dimensional imaging.	Final post treatment 1 day visit
Secondary	Global Aesthetic Improvement Scale (GAIS)	Subject- graded GAIS at 12-week post-final treatment follow-up.	Final post treatment 1 day visit