Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT04506502
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2020-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Functional Change With MMS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sally.hallas@abbvie.com', 'phone': '209-294-5571', 'title': 'Sally Hallas, RN, Director Clinical Development - Body Contouring', 'organization': 'Zeltiq Aesthetics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from the time of enrollment through the 4-week post final treatment follow-up visit, approximately 4 months.', 'description': '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).', 'eventGroups': [{'id': 'EG000', 'title': 'Magnetic Muscle Stimulation (MMS) Treatment Group', 'description': '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.\n\nThe treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.\n\nThe ZELTIQ System: The MMS device was used to perform the treatments.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 6, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Menstrual Cycle Irregularity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Alignment Flare-up', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Discomfort (Right Side)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold (Virus)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling Sensation in Lower Leg (Right)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash on Wrist (Right)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Body Satisfaction Questionnaire From Baseline to 1-month Post-Treatment Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnetic Muscle Stimulation (MMS) Treatment Group', 'description': '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.\n\nThe treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.\n\nThe ZELTIQ System: The MMS device was used to perform the treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '5.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1-month post-treatment follow-up visit', 'description': "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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Incidents of Device-Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnetic Muscle Stimulation (MMS) Treatment Group', 'description': '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.\n\nThe treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.\n\nThe ZELTIQ System: The MMS device was used to perform the treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', '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).', 'description': 'The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.', 'unitOfMeasure': 'Device-Related Adverse Events', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Magnetic Muscle Stimulation (MMS) Treatment Group', 'description': '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.\n\nThe treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.\n\nThe ZELTIQ System: The MMS device was used to perform the treatments.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Illness and subsequent quarantine requirements related to SARS-CoV-2 local guidelines', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Magnetic Muscle Stimulation (MMS) Treatment Group', 'description': '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.\n\nThe treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.\n\nThe ZELTIQ System: The MMS device was used to perform the treatments.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '10.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Data presented here as planned and collected (all enrolled).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-29', 'size': 693230, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-24T13:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2020-08-06', 'resultsFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-30', 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Satisfaction Questionnaire From Baseline to 1-month Post-Treatment Follow-up Visit', 'timeFrame': 'Baseline, 1-month post-treatment follow-up visit', 'description': "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."}, {'measure': 'Number of Incidents of Device-Related Adverse Events', '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).', 'description': 'The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Muscle Weakness']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Subject (healthy volunteer) has read and signed the study written informed consent form.\n* Male or female ≥ 22 years and ≤65 years of age.\n* Subject has not had weight change exceeding 5% of body weight in the preceding month.\n* Subject agrees to maintain body weight within 5% during the study by not making any changes in diet or exercise routine during the course of the study.\n* Subject has a BMI ≤ 30 as determined at screening.\n* Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.\n* Subject agrees to refrain from any new abdominal muscle training exercises of the treatment area during the course of the study.\n\nExclusion Criteria\n\n* Subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process.\n* Subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.\n* Subject has had an intrauterine contraceptive device inserted or removed within the past month.\n* Subject has a bleeding disorder or hemorrhagic condition\n* Subject is taking or has taken diet pills or supplements within the past month.\n* Subject has an active implanted electrical device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system.\n* Subject has metal or electronic implants in or adjacent to the treatment area\n* Subject has an abdominal hernia.\n* Subject has pulmonary insufficiency.\n* Subject has a cardiac disorder.\n* Subject has a malignant tumor.\n* Subject has been diagnosed with a seizure disorder such as epilepsy.\n* Subject currently has a fever.\n* Subject is diagnosed with Grave's disease.\n* Subject has a growth plate in the treatment area\n* Subject is pregnant or intending to become pregnant during the study period (in the next 9 months).\n* Subject is lactating or has been lactating in the past 6 months.\n* Subject is unable or unwilling to comply with the study requirements.\n* Subject is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Any other condition or laboratory value that would, in the professional opinion of the Investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject."}, 'identificationModule': {'nctId': 'NCT04506502', 'acronym': 'FMS', 'briefTitle': 'Functional Change With MMS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeltiq Aesthetics'}, 'officialTitle': 'Functional Changes With Magnetic Muscle Stimulation of Abdominal Muscle', 'orgStudyIdInfo': {'id': 'ZA19-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Muscle Toning', 'description': 'The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen.', 'interventionNames': ['Device: The ZELTIQ System']}], 'interventions': [{'name': 'The ZELTIQ System', 'type': 'DEVICE', 'description': 'The MMS device will be used to perform the treatments.', 'armGroupLabels': ['Muscle Toning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'Innovation Research Center', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeltiq Aesthetics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}