CoolSculpting and EMS for the Abdomen

NCT03738891 | Completed Results FDA Device

• 1 other identifier: ZA18-003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (2)

• 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 (2)

• Change in Pre-treatment and Post-treatment Abdominal Circumference

  Baseline and final 12-week follow-up visit.

• Percentage of Participants With Global Aesthetic Improvement Scale (S-GAIS) Reporting Improvement

  Final post-treatment 12-week follow-up visit

Study Arms (4)

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

Zeltiq CoolSculpting System alone DEVICE

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

Also known as: CoolSculpting

CoolSculpting only - Cohort 3

Electromagnetic Muscle Stimulation alone DEVICE

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

Also known as: EMS

Electromagnetic Muscle Stimulation (EMS) only - Cohort 1

EMS followed by CoolSculping DEVICE

Cohort 2 group will be treated with EMS followed by CoolSculpting

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

CoolSculpting followed by EMS DEVICE

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

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

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (4)

Marina Plastic Surgery

Marina del Rey, California, 90292, United States

Location

Innovation Research Center

Pleasanton, California, 94588, United States

Location

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Aesthetic Solutions, P.A.

Chapel Hill, North Carolina, 27517, United States

Location

Related Publications (1)

• 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.

  PMID: 32976168 RESULT

Results Point of Contact

• Title: Lori Brandt, Director, Clinical Trial Management
• Organization: Zeltiq Aesthetics

lori.brandt@abbvie.com

(925) 621-7460

Study Officials

• Kerrie Jiang, NP

  Zeltiq Aesthetics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: November 7, 2018
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)