Trial Outcomes & Findings for Magnetic Muscle Stimulation of Abdominal Muscle (NCT NCT04199312)

NCT ID: NCT04199312

Last Updated: 2025-07-02

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

TERMINATED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

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

Results posted on

2025-07-02

Participant Flow

Participants were assigned to 1 of 3 MMS treatment cohorts. As-Treated (Safety) Population includes all enrolled participants who received at least 1 treatment per protocol.

Participant milestones

Participant milestones
Measure	Cohort 1 Participants had 4 MMS treatment sessions completed twice a week, within a 2-week period.	Cohort 2 Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period.	Cohort 3 Participants had 8 MMS treatments completed twice per week within a 4-week period.
Overall Study STARTED	19	6	5
Overall Study COMPLETED	19	6	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnetic Muscle Stimulation of Abdominal Muscle

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=19 Participants Participants had 4 MMS treatment sessions completed twice a week, within a 2-week period.	Cohort 2 n=6 Participants Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period.	Cohort 3 n=5 Participants Participants had 8 MMS treatments completed twice per week within a 4-week period.	Total n=30 Participants Total of all reporting groups
Age, Continuous	46.1 years STANDARD_DEVIATION 11.3 • n=5 Participants	43.5 years STANDARD_DEVIATION 13.5 • n=7 Participants	44.2 years STANDARD_DEVIATION 14.2 • n=5 Participants	45.2 years STANDARD_DEVIATION 11.8 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

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

Population: As-Treated Population.

Outcome measures

Outcome measures
Measure	Cohort 1 n=19 Participants Participants had 4 MMS treatment sessions completed twice a week, within a 2-week period.	Cohort 2 n=6 Participants Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period.	Cohort 3 n=5 Participants Participants had 8 MMS treatments completed twice per week within a 4-week period.
Change in Body Satisfaction Questionnaire From Baseline to 1-Month Post-Treatment Follow-up Visit	6.2 units on a scale Standard Deviation 4.9	4.7 units on a scale Standard Deviation 6.1	2.8 units on a scale Standard Deviation 4.1

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.

Population: Safety Population.

An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.

Outcome measures

Outcome measures
Measure	Cohort 1 n=19 Participants Participants had 4 MMS treatment sessions completed twice a week, within a 2-week period.	Cohort 2 n=6 Participants Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period.	Cohort 3 n=5 Participants Participants had 8 MMS treatments completed twice per week within a 4-week period.
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) SADEs	0 Participants	0 Participants	0 Participants
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) Device and/ or Procedure Related AEs	1 Participants	0 Participants	0 Participants

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1 n=19 participants at risk Participants had 4 MMS treatment sessions completed twice a week, within a 2-week period.	Cohort 2 n=6 participants at risk Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period.	Cohort 3 n=5 participants at risk Participants had 8 MMS treatments completed twice per week within a 4-week period.
Reproductive system and breast disorders Menstrual Cycle Irregularity	5.3% 1/19 • Adverse event data was collected from the time of enrollment through the 8-week post-treatment follow-up visit, approximately 3 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).	0.00% 0/6 • Adverse event data was collected from the time of enrollment through the 8-week post-treatment follow-up visit, approximately 3 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).	0.00% 0/5 • Adverse event data was collected from the time of enrollment through the 8-week post-treatment follow-up visit, approximately 3 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