CoolSculpting and EMS for the Abdomen (ECA)

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

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

Study Overview

• Status: Completed
• Conditions: Body Fat Disorder
• Intervention / Treatment: Device: The ZELTIQ System

• Study Type: Interventional
• Enrollment (Actual): 50
• 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
    • Sacramento, California, United States, 95816
      • Laser & Skin Surgery Center of Northern California
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Aesthetic Solutions, P.A.

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 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.

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: Fat Reduction; The treatments are designed to see if the fat can be reduced in the abdomen.	Device: The ZELTIQ System; The CoolSculpting machine will be used to perform the treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint in relation to adverse events	Measurement of device- or procedure-related adverse events.	Final post treatment 1 day visit
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-D imaging	Reduction in abdominal circumference as measured by 3-Dimensional imaging.	Final post treatment 1 day visit
Global Aesthetic Improvement Scale (GAIS)	Subject- graded GAIS at 12-week post-final treatment follow-up.	Final post treatment 1 day visit

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Actual): September 9, 2019
• Study Completion (Actual): September 9, 2019

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: ZA18-003

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