Trial Outcomes & Findings for Functional Change With MMS (NCT NCT04506502)

Last Updated: 2025-05-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Baseline, 1-month post-treatment follow-up visit

Results posted on

2025-05-16

Participant Flow

Per protocol, subjects received magnetic muscle stimulation (MMS) treatments in the abdominal area in 8 sessions over a 1-month period. Office follow-up visits were required at 4 days, 1 month, 2 months and 3 months after the final treatment. During all visits, subjects were assessed for pain and adverse events and required study activities were performed per protocol.

Participant milestones

Participant milestones
Measure	Magnetic Muscle Stimulation (MMS) Treatment Group Each subject received two MMS treatment sessions, at least two days apart, per week for a four-week period. Treatment was performed on the abdominal region. The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen. The ZELTIQ System: The MMS device was used to perform the treatments.
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Magnetic Muscle Stimulation (MMS) Treatment Group Each subject received two MMS treatment sessions, at least two days apart, per week for a four-week period. Treatment was performed on the abdominal region. The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen. The ZELTIQ System: The MMS device was used to perform the treatments.
Overall Study Withdrawal by Subject	1
Overall Study Illness and subsequent quarantine requirements related to SARS-CoV-2 local guidelines	1

Baseline Characteristics

Functional Change With MMS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magnetic Muscle Stimulation (MMS) Treatment Group n=16 Participants Each subject received two MMS treatment sessions, at least two days apart, per week for a four-week period. Treatment was performed on the abdominal region. The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen. The ZELTIQ System: The MMS device was used to perform the treatments.
Age, Continuous	39.3 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1-month post-treatment follow-up visit

Population: Two subjects were excluded from per protocol population due to incomplete treatments and withdrawal of consent. The Per Protocol population consisted of all treated subjects that received 8 MMS treatments and with a weight change of no more than 5% of total body weight at the time the 1-month assessments were performed compared to the weight obtained at the first treatment visit.

Outcome measures

Outcome measures
Measure	Magnetic Muscle Stimulation (MMS) Treatment Group n=14 Participants Each subject received two MMS treatment sessions, at least two days apart, per week for a four-week period. Treatment was performed on the abdominal region. The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen. The ZELTIQ System: The MMS device was used to perform the treatments.
Change in Body Satisfaction Questionnaire From Baseline to 1-month Post-Treatment Follow-up Visit	8.6 units on a scale Standard Deviation 5.4

PRIMARY outcome

Timeframe: 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).

Population: All participants enrolled in the study and treated with the EMS device were evaluated for adverse events throughout the study. Investigators determined if an AE was not related, possibly related, probably related or definitely related to the study device. Data is presented here as planned and collected per protocol by the total As-Treated Population (defined as all treated participants regardless of weight change).

The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.

Outcome measures

Outcome measures
Measure	Magnetic Muscle Stimulation (MMS) Treatment Group n=16 Participants Each subject received two MMS treatment sessions, at least two days apart, per week for a four-week period. Treatment was performed on the abdominal region. The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen. The ZELTIQ System: The MMS device was used to perform the treatments.
Number of Incidents of Device-Related Adverse Events	1 Device-Related Adverse Events

Adverse Events

Magnetic Muscle Stimulation (MMS) Treatment Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Magnetic Muscle Stimulation (MMS) Treatment Group n=16 participants at risk Each subject received two MMS treatment sessions, at least two days apart, per week for a four-week period. Treatment was performed on the abdominal region. The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen. The ZELTIQ System: The MMS device was used to perform the treatments.
Reproductive system and breast disorders Menstrual Cycle Irregularity	6.2% 1/16 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 4-week post final treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
Musculoskeletal and connective tissue disorders Back Alignment Flare-up	6.2% 1/16 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 4-week post final treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
General disorders Abdominal Discomfort (Right Side)	6.2% 1/16 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 4-week post final treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
Musculoskeletal and connective tissue disorders Upper Back Pain	6.2% 1/16 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 4-week post final treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
General disorders Cold (Virus)	6.2% 1/16 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 4-week post final treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
Nervous system disorders Tingling Sensation in Lower Leg (Right)	6.2% 1/16 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 4-week post final treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
Skin and subcutaneous tissue disorders Rash on Wrist (Right)	6.2% 1/16 • Number of events 1 • Adverse event data was collected from the time of enrollment through the 4-week post final treatment follow-up visit, approximately 4 months. Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).

Additional Information

Sally Hallas, RN, Director Clinical Development - Body Contouring

Zeltiq Aesthetics

Phone: 209-294-5571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place