Functional Change With MMS

Not Applicable

Completed

• Conditions: Muscle Weakness

• Registration Number: NCT04506502
• 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: 2020-03-04
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Primary Completion: 2021-05-18
• Study Completion: 2021-07-06
• Status Verified: 2025-04
• Results First Submitted: 2025-04-07
• Results First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Results First Posted: 2025-05-16
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Body Satisfaction Questionnaire From Baseline to 1-month Post-Treatment Follow-up Visit	Baseline, 1-month post-treatment follow-up visit	Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ) at the 1-month post-treatment follow-up visit. The scale measures body image using a set of dichotomous items used to describe aspects of shape and appearance. The questionnaire has total score range from 10 to 50. An increase in score (when compared to baseline) reflects the participant's perceived improvement in appearance in the treated region (abdomen). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 1-month post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.
Number of Incidents of Device-Related Adverse Events	AE information will be collected from the time of enrollment to the final follow-up visit at 3-months following the final treatment (approximately 4 months).	The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.

Trial Locations

Locations (1)

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