Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-03-03 @ 4:42 PM
Study NCT ID:
NCT04199806
Status:
WITHDRAWN
Last Update Posted:
2019-12-16
First Post:
2019-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study of Patient Surveys
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This is a retrospective study reviewing subject questionnaires. No treatments will be administered in this study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2019-12-03', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy Endpoint: Overall Experience Questionnaire', 'timeFrame': 'Immediately post subjects final treatment.', 'description': 'Evaluation of patient overall experience with MMS treatment as measured by patient survey.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Body Fat Disorder']}, 'descriptionModule': {'briefSummary': 'To collect data from Allergan Patient Surveys (patient surveys) and Allergan Patient Information Form (patient information form) to describe:\n\n1. Patient demographics\n2. Treatment patterns\n3. Patient feedback and overall experience with MMS treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Subject has received MMS treatment in the abdomen and/or buttocks (with CoolTone prototype)\n* Subject has completed the Allergan patient survey and information form on MMS experience between July 1, 2019 and December 1, 2019.\n\nExclusion Criteria\n\n• There are no exclusion criteria for this study.'}, 'identificationModule': {'nctId': 'NCT04199806', 'briefTitle': 'Retrospective Study of Patient Surveys', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeltiq Aesthetics'}, 'officialTitle': 'Retrospective Study of Patient Surveys of MMS Experience', 'orgStudyIdInfo': {'id': 'ZA19-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Questionnaire Review', 'interventionNames': ['Other: Questionnaire review']}], 'interventions': [{'name': 'Questionnaire review', 'type': 'OTHER', 'description': 'Review data from questionnaires received about MMS experience.', 'armGroupLabels': ['Questionnaire Review']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kerrie Jiang, NP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zeltiq Aesthetics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeltiq Aesthetics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}