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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 |
|---|---|---|---|
| Muscle Toning | Experimental | The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The ZELTIQ System | 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 Incidents of Device-Related Adverse Events | The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated. | 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). |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovation Research Center | Pleasanton | California | 94588 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Data presented here as planned and collected (all enrolled).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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. | 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. | 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 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).
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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 | 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. |
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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 | Jan 29, 2020 | Apr 24, 2025 | Prot_SAP_001.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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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
|
|
| Primary | Number of Incidents of Device-Related Adverse Events | The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated. | 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). | Posted | Number | 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). |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 6 |
| 16 |
| Back Alignment Flare-up | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Abdominal Discomfort (Right Side) | General disorders | Non-systematic Assessment |
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| Upper Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Cold (Virus) | General disorders | Non-systematic Assessment |
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| Tingling Sensation in Lower Leg (Right) | Nervous system disorders | Non-systematic Assessment |
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| Rash on Wrist (Right) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |