CoolSculpting and EMS for the Abdomen

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2019-09-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CoolSculpting and RF for the Submental

NCT03873779

Body Fat Disorder

COMPLETED NA

Analysis of CoolSculpting by Zeltiq for Non-Invasive Cooling of Abdominal Fat Using the eZ App Large Applicator

NCT01318343

Abdominal Fat Adipose Tissue, Abdominal

COMPLETED

DualSculpting the Abdomen Using CoolSculpting

NCT02941146

Body Fat Disorder

COMPLETED NA

Magnetic Muscle Stimulation of Abdominal Muscle

NCT04199312

Muscle Weakness

TERMINATED NA

Multiple CoolSculpting Treatment Study

NCT01814007

Body Fat Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Body Fat Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Electromagnetic Muscle Stimulation (EMS) only - Cohort 1

Subjects in this group will be treated with 4 sessions of EMS. CoolSculpting will not be used.

Group Type EXPERIMENTAL

Electromagnetic Muscle Stimulation alone

Intervention Type DEVICE

The EMS device(s) alone are used in Cohort 1.

Electromagnetic Muscle Stimulation (EMS) followed by CoolSculpting- Cohort 2

Following 4 sessions of EMS, subjects will receive 3-6 cycles of CoolSculpting.

Group Type EXPERIMENTAL

EMS followed by CoolSculping

Intervention Type DEVICE

Cohort 2 group will be treated with EMS followed by CoolSculpting

CoolSculpting only - Cohort 3

Subjects in this arm will receive 3-6 cycles of CoolSculpting treatments.

Group Type EXPERIMENTAL

Zeltiq CoolSculpting System alone

Intervention Type DEVICE

The CoolSculpting System will be used to perform the treatments in Cohort 3.

CoolSculpting followed by Electromagnetic Muscle Stimulation (EMS )- Cohort 4

Subjects in this group will have 3-6 cycles of CoolSculpting followed by 4 EMS sessions.

Group Type EXPERIMENTAL

CoolSculpting followed by EMS

Intervention Type DEVICE

Cohort 4 will be treated first with CoolSculpting, followed by EMS.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zeltiq CoolSculpting System alone

The CoolSculpting System will be used to perform the treatments in Cohort 3.

Intervention Type DEVICE

Electromagnetic Muscle Stimulation alone

The EMS device(s) alone are used in Cohort 1.

Intervention Type DEVICE

EMS followed by CoolSculping

Cohort 2 group will be treated with EMS followed by CoolSculpting

Intervention Type DEVICE

CoolSculpting followed by EMS

Cohort 4 will be treated first with CoolSculpting, followed by EMS.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CoolSculpting EMS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes