CoolSculpting and EMS for the Abdomen (ECA)

• ClinicalTrials.gov Identifier: NCT03738891
• Recruitment Status: Completed
• First Posted: November 13, 2018
• Last Update Posted: August 18, 2020
• Sponsor: Zeltiq Aesthetics
• Information provided by (Responsible Party): Zeltiq Aesthetics

Tracking Information

• First Submitted Date: November 8, 2018
• First Posted Date: November 13, 2018
• Last Update Posted Date: August 18, 2020
• Actual Study Start Date: November 7, 2018
• Actual Primary Completion Date: September 9, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 9, 2018)

• Safety endpoint in relation to adverse events [ Time Frame: Final post treatment 1 day visit ]
  Measurement of device- or procedure-related adverse events.
• Effectiveness endpoint gauged by photographs [ Time Frame: Final post treatment 1 day visit ]
  Comparison of pre-treatment- and 12-week post-final treatment photographs to assess visible changes in the abdomen.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 9, 2018)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CoolSculpting and EMS for the Abdomen
• Official Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for Abdominal Contouring
• Brief Summary: Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Body Fat Disorder

Intervention

Device: The ZELTIQ System

The CoolSculpting machine will be used to perform the treatments.

Study Arms

Experimental: Fat Reduction

The treatments are designed to see if the fat can be reduced in the abdomen.

Intervention: Device: The ZELTIQ System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 14, 2020): 50
• Original Estimated Enrollment (submitted: November 9, 2018): 60
• Actual Study Completion Date: September 9, 2019
• Actual Primary Completion Date: September 9, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03738891
• Other Study ID Numbers: ZA18-003
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Zeltiq Aesthetics
• Study Sponsor: Zeltiq Aesthetics
• Collaborators: Not Provided

Investigators

• Study Director: Kerrie Jiang, NP; Zeltiq Aesthetics

• PRS Account: Zeltiq Aesthetics
• Verification Date: August 2020