CoolSculpting and EMS for the Abdomen | NCT03738891

NCT03738891

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Electromagnetic Muscle Stimulation (EMS) only - Cohort 1	Experimental	Subjects in this group will be treated with 4 sessions of EMS. CoolSculpting will not be used.	Device: Electromagnetic Muscle Stimulation alone
Electromagnetic Muscle Stimulation (EMS) followed by CoolSculpting- Cohort 2	Experimental	Following 4 sessions of EMS, subjects will receive 3-6 cycles of CoolSculpting.	Device: EMS followed by CoolSculping
CoolSculpting only - Cohort 3	Experimental	Subjects in this arm will receive 3-6 cycles of CoolSculpting treatments.	Device: Zeltiq CoolSculpting System alone
CoolSculpting followed by Electromagnetic Muscle Stimulation (EMS )- Cohort 4	Experimental	Subjects in this group will have 3-6 cycles of CoolSculpting followed by 4 EMS sessions.	Device: CoolSculpting followed by EMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zeltiq CoolSculpting System alone	Device	The CoolSculpting System will be used to perform the treatments in Cohort 3.	CoolSculpting only - Cohort 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Unanticipated Adverse Device Effects (UADE)	The number of UADEs occurring during the study will be tabulated.	Enrollment through the final 12-week follow-up visit.
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)	Comparison of pre-treatment- and 12-week post-final treatment photographs by independent physician reviewer. The reviewer was blinded to the method of treatment and study cohort; baseline and 12-week post-treatment photos were not blinded. After Sponsor training, the reviewer entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").	Baseline photos will be compared to images collected at the final 12-week post-treatment follow-up visit.

Secondary Outcomes

Measure	Description	Time Frame
Change in Pre-treatment and Post-treatment Abdominal Circumference	Abdominal circumference as measured by 3-Dimensional imaging prior to treatment (baseline) is compared to images collected at the final 12-week post-treatment follow-up visit. Measurements were captured at 3 points including the upper, middle and lower abdomen. All measurements were averaged per subject at the baseline and 12-week visit time points to obtain circumference values. Results for each cohort are shown in millimeters of circumference reduction.

Eligibility Module

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/m^2 as determined at screening.
Abdominal skin fold thickness 2.0 to 5.0 cm, as measured by caliper below umbilicus.
Cohort 4 only: Subject participated in protocol ZA18-003 in Cohort 3, and received the CoolSculpting treatment no more than 6 months prior.
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.

Name	Affiliation	Role
Kerrie Jiang, NP	Zeltiq Aesthetics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Marina Plastic Surgery		Marina del Rey	California	90292	United States
Innovation Research Center

PubMed Identifier	Type	Citation	Retractions
32976168	Result	Kilmer SL, Cox SE, Zelickson BD, Bachelor EP, Gamio S, Ostrowski R, Pham LD, Stevens WG. Feasibility Study of Electromagnetic Muscle Stimulation and Cryolipolysis for Abdominal Contouring. Dermatol Surg. 2020 Oct;46 Suppl 1(1):S14-S21. doi: 10.1097/DSS.0000000000002420.

Arm/Group Information

ID	Title	Description
FG000	Cohort 1-EMS Only	Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used.
FG001	Cohort 2 - EMS Followed by CoolSculpting	Participants were treated with EMS (4 sessions) followed by 1 CoolSculpting treatment (3-6 cooling cycles)
FG002	Cohort 3 - CoolSculpting Only	Participants were treated with 1 CoolSculpting treatment (3-6 cooling cycles)
FG003	Cohort 4	Participants were treated with 1 CoolSculpting treatment (3-6 cooling cycles) followed by 4 sessions of EMS.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Cohort 1-EMS Only	Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used.
BG001	Cohort 2 - EMS Followed by CoolSculpting

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Unanticipated Adverse Device Effects (UADE)

The number of UADEs occurring during the study will be tabulated.

All Participants who received at least one study treatment. Participants in all cohorts were evaluated for adverse events.

Posted

Number

events

Enrollment through the final 12-week follow-up visit.

ID	Title	Description
OG000	Cohort 1-EMS Only	Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used.
OG001	Cohort 2 - EMS and CoolSculpting	Following 4 sessions of EMS, participants received 3-6 cycles of CoolSculpting.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1-EMS Only	Participants in this group were treated with 4 sessions of Electromagnetic Muscle Stimulation (EMS). CoolSculpting was not used.