Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT04619992
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2020-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Consumer Evaluation of Intermittent Catheter Product Modifications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sara.wegener@hollister.com', 'phone': '+1 224-206-2857', 'title': 'Director of Global Clinical Affairs', 'organization': 'Hollister Incorporated'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.', 'eventGroups': [{'id': 'EG000', 'title': 'Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters', 'description': 'Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.\n\nTest Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 7, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters', 'description': 'Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.\n\nCurrently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter\n\nTest Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Potential viral infection', 'notes': 'Probably not related to study product. Mild severity. Subject reported increased fatigue and muscular aches. Undiagnosed but most likely due to viral infection. No urinary tract infection present. Self-resolved after few days.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle surgery', 'notes': 'Unrelated to study product. Mild severity. Subject underwent ankle surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal discomfort', 'notes': 'Unrelated to study product. Mild severity. Subject reported loose stools. Self-resolved after few days.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'notes': 'Probably not related to study product. Moderate severity. Subject undergoing bowel management program. History of urinary tract infections during bowel training.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral discomfort', 'notes': 'Possibly related to study product. Mild severity. Burning sensation while inserting urinary catheter for initial insertions. No other urinary or product complications present.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cloudy urine', 'notes': 'Probably not related to study product. Mild in severity. Subject reports cloudy urine. Resolved after 48 hours. No other urinary complications present.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reduced urine flow and hip spasticity', 'notes': 'Possibly related to study product. Mild in severity. Subject reported sensation of incomplete bladder voiding and hip spasticity. Improper storage of study product led to potential kinking of catheter tube. Issue resolved after proper storage.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Potential urethral narrowing', 'notes': 'Unrelated to study product. Moderate severity. Subject had difficulty inserting catheter due to potential urethral narrowing. This complication was present prior to use of study product and under the care of healthcare provider.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptability of Test Hydrophilic Intermittent Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters', 'description': 'Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.\n\nTest Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements'}, {'id': 'OG001', 'title': 'New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters', 'description': 'Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.\n\nCurrently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter\n\nTest Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements'}], 'classes': [{'categories': [{'title': "'Strongly agree' or 'Agree'", 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Neither agree nor disagree', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': "'Disagree' or 'Strongly disagree'", 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 days', 'description': 'Users will rate if Test device is an acceptable alternative to currently marketed device. Acceptability will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is an acceptable alternative to currently marketed catheter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Preference of Test Hydrophilic Intermittent Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters', 'description': 'Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.\n\nTest Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements'}, {'id': 'OG001', 'title': 'New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters', 'description': 'Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.\n\nCurrently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter\n\nTest Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements'}], 'classes': [{'categories': [{'title': "'Strongly agree' or 'Agree'", 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Neither agree nor disagree', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': "'Disagree' or 'Strongly disagree'", 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 days', 'description': 'Users will rate if Test device is preferred to currently marketed device. Preference will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is preferred to currently marketed catheter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters', 'description': 'Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.\n\nTest Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements'}, {'id': 'FG001', 'title': 'New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters', 'description': 'Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.\n\nCurrently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter\n\nTest Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters', 'description': 'Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.\n\nTest Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements'}, {'id': 'BG001', 'title': 'New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters', 'description': 'Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.\n\nCurrently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter\n\nTest Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': '<18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '18-29 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '30-39 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '40-49 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '50-59 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '60-69 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '70-79 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '80-89 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Per protocol inclusion criteria, only males were eligible for participation.', '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': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-13', 'size': 756037, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-27T15:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2020-10-27', 'resultsFirstSubmitDate': '2022-06-02', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-01', 'studyFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of Test Hydrophilic Intermittent Catheter', 'timeFrame': '10 days', 'description': 'Users will rate if Test device is an acceptable alternative to currently marketed device. Acceptability will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is an acceptable alternative to currently marketed catheter.'}, {'measure': 'Preference of Test Hydrophilic Intermittent Catheter', 'timeFrame': '10 days', 'description': 'Users will rate if Test device is preferred to currently marketed device. Preference will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is preferred to currently marketed catheter.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isUnapprovedDevice': True}, 'conditionsModule': {'keywords': ['Intermittent Catheterization'], 'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'A. Inclusion Criteria for Arm 1\n\nSubject who:\n\n1. is male and at least 18 years of age\n2. has been performing unassisted, self-catheterizations, with a Hollister standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month\n\nB. Exclusion Criteria for Arm 1\n\nSubject who:\n\n1. is currently undergoing chemotherapy, radiation or steroid therapy\n2. has a symptomatic urinary tract infection (UTI)\n3. is currently using a coude intermittent catheter product to perform catheterization\n4. performs non-urethral catheterization\n\nC. Inclusion Criteria for Arm 2\n\nSubject who:\n\n1. is male and at least 18 years of age\n2. has been performing unassisted, self-catheterizations, with a non-standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month\n\nD. Exclusion Criteria for Arm 2\n\nSubject who:\n\n1. is currently undergoing chemotherapy, radiation or steroid therapy\n2. has a symptomatic urinary tract infection (UTI)\n3. is currently using a coude intermittent catheter product to perform catheterization\n4. performs non-urethral catheterization\n5. is unable to use a Hollister standard with tip hydrophilic intermittent catheter'}, 'identificationModule': {'nctId': 'NCT04619992', 'briefTitle': 'Consumer Evaluation of Intermittent Catheter Product Modifications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hollister Incorporated'}, 'officialTitle': 'Consumer Evaluation of Intermittent Catheter Product Modifications', 'orgStudyIdInfo': {'id': '6009-CONT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Current users of Hollister standard with tip hydrophilic intermittent catheters', 'description': 'Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.', 'interventionNames': ['Device: Test Hydrophilic Intermittent Catheter']}, {'type': 'OTHER', 'label': 'New users of Hollister standard with tip hydrophilic intermittent catheters', 'description': 'Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.', 'interventionNames': ['Device: Currently marketed Hydrophillic Intermittent Catheter', 'Device: Test Hydrophilic Intermittent Catheter']}], 'interventions': [{'name': 'Currently marketed Hydrophillic Intermittent Catheter', 'type': 'DEVICE', 'description': 'Currently marketed Hollister standard with tip hydrophilic intermittent catheter', 'armGroupLabels': ['New users of Hollister standard with tip hydrophilic intermittent catheters']}, {'name': 'Test Hydrophilic Intermittent Catheter', 'type': 'DEVICE', 'description': 'Hollister standard with tip hydrophilic intermittent catheter with design enhancements', 'armGroupLabels': ['Current users of Hollister standard with tip hydrophilic intermittent catheters', 'New users of Hollister standard with tip hydrophilic intermittent catheters']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60048', 'city': 'Libertyville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hollister Incorporated', 'geoPoint': {'lat': 42.28308, 'lon': -87.95313}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hollister Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}