Magnetic Muscle Stimulation of Abdominal Muscle

Not Applicable

• Conditions: Muscle Weakness
• Interventions: Device: The ZELTIQ System

• Registration Number: NCT04199312
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Muscle Toning, Firming and Strengthening	The ZELTIQ System	The EMS device will be evaluated for muscle toning, firming and strengthening in the abdomen.

Primary Outcome Measures

Name	Time	Method
Efficacy Endpoint: Body Satisfaction Scale (BSS)	one-month post final treatment	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.

Trial Locations

Locations (3)

Innovation Research Center; 🇺🇸 Pleasanton, California, United States

Investigate MD; 🇺🇸 Scottsdale, Arizona, United States

Laser and Skin Surgery Center of Northern California; 🇺🇸 Sacramento, California, United States