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Sponsor Discontinued due to business decision.
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Evaluate the safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Magnetic Muscle Stimulation (MMS) | Experimental | Participants had a total of 4 MMS treatment sessions completed twice a week, within a 2-week period. |
|
| Cohort 2: Magnetic Muscle Stimulation (MMS) | Experimental | Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period. |
|
| Cohort 3: Magnetic Muscle Stimulation (MMS) | Experimental | Participants had 8 MMS treatments completed twice per week within a 4-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Muscle Stimulation (MMS) device | Device | The MMS device will be used to perform the treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Satisfaction Questionnaire From Baseline to 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. | Baseline, 1-month post-treatment follow-up visit |
| Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | 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. | AE information will be collected from the time of enrollment to the final follow-up visit at 3-months following the final treatment. |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigate MD | Scottsdale | Arizona | 85255 | United States | ||
| Innovation Research Center |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Participants had 4 MMS treatment sessions completed twice a week, within a 2-week period. |
| FG001 | Cohort 2 | Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period. |
| FG002 | Cohort 3 | Participants had 8 MMS treatments completed twice per week within a 4-week period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data presented here as planned and collected (all enrolled).
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participants had 4 MMS treatment sessions completed twice a week, within a 2-week period. |
| BG001 | Cohort 2 | Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Satisfaction Questionnaire From Baseline to 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. | As-Treated Population. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1-month post-treatment follow-up visit |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Participants had 4 MMS treatment sessions completed twice a week, within a 2-week period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Menstrual Cycle Irregularity | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sally Hallas, RN, Director Clinical Development - Body Contouring | Zeltiq Aesthetics | 209-294-5571 | sally.hallas@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2020 | May 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| Pleasanton |
| California |
| 94588 |
| United States |
| Laser and Skin Surgery Center of Northern California | Sacramento | California | 95816 | United States |
| BG002 | Cohort 3 | Participants had 8 MMS treatments completed twice per week within a 4-week period. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants had 4 MMS treatment sessions completed twice a week, within a 2-week period. |
| OG001 | Cohort 2 | Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period. |
| OG002 | Cohort 3 | Participants had 8 MMS treatments completed twice per week within a 4-week period. |
|
|
| Primary | Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | 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. | Safety Population. | Posted | Count of Participants | Participants | AE information will be collected from the time of enrollment to the final follow-up visit at 3-months following the final treatment. |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | Cohort 2 | Participants had 6 MMS treatment sessions completed twice a week, within a 3-week period. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Cohort 3 | Participants had 8 MMS treatments completed twice per week within a 4-week period. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
|