Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT02401412
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2015-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Advocate Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stacy.haddad@hollister.com', 'phone': '847-680-2837', 'title': 'Stacy Haddad, Global Clinical Affairs Director', 'organization': 'Hollister Incorporated'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product.\n\nAdverse Events were reported for the modified ITT population which excluded subjects who\n\n1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16)\n2. did not receive the study device; (n=1)\n\nAs such AEs reported for 153 (170-17) subjects', 'eventGroups': [{'id': 'EG000', 'title': 'Test Ostomy Barrier', 'description': 'The test product is a new Hollister ostomy barrier.\n\nTest Ostomy Barrier', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 6, 'seriousNumAtRisk': 79, 'deathsNumAffected': 2, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Control Ostomy Barrier', 'description': 'The control product is a currently marketed Hollister ostomy barrier.\n\nControl Ostomy Barrier', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 11, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Elective colonoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incisional Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal Blockage/Illeus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stoma abrasion caused by patient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ostomy pouching system not secure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peristomal Skin Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stoma complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death due to septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal Blockage/Illeus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death due to primary cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflamed gall bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-specific Failure to Thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-specific Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stoma Related Cost of Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Ostomy Barrier', 'description': 'The test product is a new Hollister ostomy barrier.\n\nTest Ostomy Barrier'}, {'id': 'OG001', 'title': 'Control Ostomy Barrier', 'description': 'The control product is a currently marketed Hollister ostomy barrier.\n\nControl Ostomy Barrier'}], 'classes': [{'categories': [{'measurements': [{'value': '223.73', 'groupId': 'OG000', 'lowerLimit': '210.86', 'upperLimit': '236.60'}, {'value': '260.19', 'groupId': 'OG001', 'lowerLimit': '242.79', 'upperLimit': '277.58'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': '12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.', 'unitOfMeasure': 'USD', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as a modified ITT population which excluded subjects who\n\n1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16)\n2. did not receive the study device; (n=1)\n\nAs such 153 (170-17) subjects were eligible for analysis'}, {'type': 'SECONDARY', 'title': 'Peristomal Skin Complication Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Ostomy Barrier', 'description': 'The test product is a new Hollister ostomy barrier.\n\nTest Ostomy Barrier'}, {'id': 'OG001', 'title': 'Control Ostomy Barrier', 'description': 'The control product is a currently marketed Hollister ostomy barrier.\n\nControl Ostomy Barrier'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Observed 8 week Peristomal Skin Complication (PSC) rate. The validated Ostomy Skin Tool DET score was used to describe the status of the peristomal skin. Subjects were deemed to have had a PSC if the DET score was above zero due to anything other than normal postoperative healing and/or scar tissue, or the DET score increased above the normal score obtained at a previous visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as a modified ITT population which excluded subjects who\n\n1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16)\n2. did not receive the study device; (n=1)\n\nAs such 153 (170-17) subjects were eligible for analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Ostomy Barrier', 'description': 'The test product is a new Hollister ostomy barrier.\n\nTest Ostomy Barrier'}, {'id': 'FG001', 'title': 'Control Ostomy Barrier', 'description': 'The control product is a currently marketed Hollister ostomy barrier.\n\nControl Ostomy Barrier'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'Received Study Device', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Discontinued Intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Subject withdrawal prior to intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Improper Enrollment per In/Ex Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Ostomy Barrier', 'description': 'The test product is a new Hollister ostomy barrier.\n\nTest Ostomy Barrier'}, {'id': 'BG001', 'title': 'Control Ostomy Barrier', 'description': 'The control product is a currently marketed Hollister ostomy barrier.\n\nControl Ostomy Barrier'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.4', 'spread': '24.8', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '15.2', 'groupId': 'BG001'}, {'value': '56.3', 'spread': '15.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.8', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '26.4', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '25.6', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The analysis population was defined as a modified ITT population which excluded subjects who\n\n1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16)\n2. did not receive the study device; (n=1)\n\nAs such 153 (170-17) subjects were eligible for analysis'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-09', 'size': 563925, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-03-29T11:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2015-03-24', 'resultsFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-13', 'studyFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stoma Related Cost of Care', 'timeFrame': '12 weeks', 'description': '12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.'}], 'secondaryOutcomes': [{'measure': 'Peristomal Skin Complication Rate', 'timeFrame': '8 weeks', 'description': 'Observed 8 week Peristomal Skin Complication (PSC) rate. The validated Ostomy Skin Tool DET score was used to describe the status of the peristomal skin. Subjects were deemed to have had a PSC if the DET score was above zero due to anything other than normal postoperative healing and/or scar tissue, or the DET score increased above the normal score obtained at a previous visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ostomy']}, 'descriptionModule': {'briefSummary': 'Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOstomy patients who:\n\n* Have healthy peristomal skin\n* Are within 12 weeks post op\n\nExclusion Criteria:\n\nOstomy patients who:\n\n* Have a fistula, wound, lesion or suspected infection in the peristomal area\n* Are in-patient in healthcare facility'}, 'identificationModule': {'nctId': 'NCT02401412', 'briefTitle': 'The Advocate Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hollister Incorporated'}, 'officialTitle': 'A Study Determining Variances in Ostomy Skin Conditions And The Economic Impact.', 'orgStudyIdInfo': {'id': '5787-O'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Test Ostomy Barrier', 'description': 'The test product is a new Hollister ostomy barrier.', 'interventionNames': ['Device: Test Ostomy Barrier']}, {'type': 'OTHER', 'label': 'Control Ostomy Barrier', 'description': 'The control product is a currently marketed Hollister ostomy barrier.', 'interventionNames': ['Device: Control Ostomy Barrier']}], 'interventions': [{'name': 'Test Ostomy Barrier', 'type': 'DEVICE', 'armGroupLabels': ['Test Ostomy Barrier']}, {'name': 'Control Ostomy Barrier', 'type': 'DEVICE', 'armGroupLabels': ['Control Ostomy Barrier']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92508', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Stoia Consultants', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Jupiter Medical Center', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33881', 'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', 'facility': 'Winter Haven Hospital', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47303', 'city': 'Muncie', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Health Ball Memorial University', 'geoPoint': {'lat': 40.19338, 'lon': -85.38636}}, {'zip': '64119', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Restored Images', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '44223', 'city': 'Cuyahoga Falls', 'state': 'Ohio', 'country': 'United States', 'facility': "Klein's Orthopedic & Medical Supply", 'geoPoint': {'lat': 41.13394, 'lon': -81.48456}}, {'zip': '44504', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'St. Elizabeth Hospital', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': 'V1M 3C2', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Lakeside Medicine Center', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V9S 5W4', 'city': 'Nanaimo', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pharmasave', 'geoPoint': {'lat': 49.16638, 'lon': -123.94003}}, {'zip': 'V3M 2T5', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Ostomy Care Centre', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'zip': 'M1E 489', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Rouge Valley Health System', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Mark Kalifa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hollister Incorporated'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hollister Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}