Magnetic Muscle Stimulation of Abdominal Muscle

Muscle Weakness Clinical Trial

— MMS  

Official title:

Magnetic Muscle Stimulation of Abdominal Muscle

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199312
• Other study ID #: ZA19-001
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: Zeltiq Aesthetics
• Contact: Tonia N Madere
• Phone: 925-474-2537
• Email: tonia.madere[@]allergan.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness

Intervention

Device:
• The ZELTIQ System
The MMS device will be used to perform the treatments.

Locations

Country	Name	City	State
United States	Innovation Research Center	Pleasanton	California
United States	Laser and Skin Surgery Center of Northern California	Sacramento	California
United States	Investigate MD	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Zeltiq Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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