Magnetic Muscle Stimulation of Abdominal Muscle (MMS)

Evaluate the safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle.

Study Overview

• Status: Unknown
• Conditions: Muscle Weakness
• Intervention / Treatment: Device: The ZELTIQ System

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Recruiting
      • Investigate MD
      • Contact: Jenna Sanford; Phone Number: 480-440-5985; Email: jsanford@investigatemd.com
      • Principal Investigator: Brenda LaTowsky, MD
  • California
    • Pleasanton, California, United States, 94588
      • Active, not recruiting
      • Innovation Research Center
    • Sacramento, California, United States, 95816
      • Active, not recruiting
      • Laser and Skin Surgery Center of Northern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Male or female ≥ 22 years and ≤65 years of age.
• Subject has not had weight change exceeding 5% of body weight in the preceding month.
• Subject agrees to maintain body weight within 5% during the study by not making any changes in diet or exercise routine.
• Subject has a BMI ≤ 30 as determined at screening.
• Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
• Subject agrees to have MRI during the scheduled time periods.
• Subject agrees to refrain from any new abdominal muscle training exercises of the treatment area during the course of the study.
• Subject agrees to avoid sun tanning during the course of the study.
• Subject has read and signed the study written informed consent form.

Exclusion Criteria

• Subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process.
• 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 procedure (e.g. CoolSculpting, SculpSure) in the area of intended treatment within the past 6 months.
• 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 had an intrauterine contraceptive device inserted or removed within the past month.
• Subject has a bleeding disorder or hemorrhagic condition
• Subject is taking or has taken diet pills or supplements within the past month.
• Subject has an active implanted electrical device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system
• Subject has metal or electronic implants in or adjacent to the treatment area
• Subject has an abdominal hernia
• Subject has pulmonary insufficiency.
• Subject has a cardiac disorder.
• Subject has a malignant tumor.
• Subject has been diagnosed with a seizure disorder such as epilepsy.
• Subject currently has a fever.
• Subject is diagnosed with Grave's disease.
• Subject has a growth plate in the treatment area
• 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 has any contraindications to MRI (e.g. metal implant, history of metal work or metal slivers in eye, prone to severe claustrophobia).
• Subject is unable or unwilling to comply with the study requirements.
• Subject is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
• 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: Muscle Toning, Firming and Strengthening; The EMS device will be evaluated for muscle toning, firming and strengthening in the abdomen.	Device: The ZELTIQ System; The MMS device will be used to perform the treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoint: Body Satisfaction Scale (BSS)	Change in subject perception of body shape as measured using the Body Satisfaction Scale (BSS) at the one-month post-final-treatment follow-up visit.	one-month post final treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: ZA19-001

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