Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-03 @ 1:23 AM
Study NCT ID:
NCT02675634
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2016-01-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dksargo@coloplast.com', 'phone': '+45 49113568', 'title': 'Sara Gosk', 'organization': 'Scientific and Regulatory affairs'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from subject enrollment to the subject left the study. Subjects with serious adverse events were followed until their condition was resolved.', 'eventGroups': [{'id': 'EG000', 'title': 'Test A', 'description': 'This is the result from all subjects evaluating Test A', 'otherNumAtRisk': 52, 'otherNumAffected': 8, 'seriousNumAtRisk': 52, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Test B', 'description': 'This is the results from all the subjects evaluating Test B', 'otherNumAtRisk': 54, 'otherNumAffected': 11, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Own Product', 'description': 'this is the result from all the subjects evaluating Own product.', 'otherNumAtRisk': 51, 'otherNumAffected': 4, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Peristomal skin dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Obstibation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fit to Body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test A', 'description': 'This is the result from all subjects evaluating Test A'}, {'id': 'OG001', 'title': 'Test B', 'description': 'This is the results from all the subjects evaluating Test B'}, {'id': 'OG002', 'title': 'Own Product', 'description': 'this is the result from all the subjects evaluating Own product.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 +/- 2 days', 'description': 'Subjects will evaluate the fit to body for each product by answering the question "how was the baseplates ability to fit the body contours in the area around the stoma?" The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered \'Good\' or\' Very Good\' to the question.', 'unitOfMeasure': 'percentage of good or very good', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test A, Test B, Subjects Own Product', 'description': 'The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product\n\nColoplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nColoplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nSubjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.'}, {'id': 'FG001', 'title': 'Test A, Subjects Own Product, Test B', 'description': 'The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B\n\nColoplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nColoplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nSubjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.'}, {'id': 'FG002', 'title': 'Test B, Test A, Subjects Own Product', 'description': 'The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product\n\nColoplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nColoplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nSubjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.'}, {'id': 'FG003', 'title': 'Test B, Subjects Own Product, Test A', 'description': 'The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A\n\nColoplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nColoplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nSubjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.'}, {'id': 'FG004', 'title': 'Subjects Own Product, Test A, Test B', 'description': 'The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B\n\nColoplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nColoplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nSubjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.'}, {'id': 'FG005', 'title': 'Subjects Own Product, Test B, Test A', 'description': 'The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A\n\nColoplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nColoplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S\n\nSubjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.'}], 'periods': [{'title': 'Test Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Device deficiency that did not lead to A', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Test Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Test Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The subjects were recruited through the Coloplast A/S database and from hospital sites'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'The Study Population', 'description': 'This consists of all participants who were enrolled in the study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One subject did not aswer the gender question therefore this information is missing.'}], 'populationDescription': 'The baseline population consist of all enrolled subjects'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2016-01-29', 'resultsFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2016-02-02', 'lastUpdatePostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-04', 'studyFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fit to Body', 'timeFrame': '14 +/- 2 days', 'description': 'Subjects will evaluate the fit to body for each product by answering the question "how was the baseplates ability to fit the body contours in the area around the stoma?" The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered \'Good\' or\' Very Good\' to the question.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ileostomy', 'Colostomy']}, 'descriptionModule': {'briefSummary': 'This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Have given written informed consent and in DK: signed a letter of authority 2. Are at least 18 years of age and have full legal capacity 3. Have had their ileostomy or colostomy for at least 3 months 4. Are able to use a baseplate cut-max 15 to 40 mm 5. Are able to handle the product themselves 6. Currently using a 1-piece flat product 8. Willing to use an open bag size maxi during the investigation 9. Are able to use a custom cut (custom fit) product 10. Are suitable for participating in the investigation - this means that the subjects must be able to follow all elements of the study procedures.\n\nExclusion Criteria:\n\n1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)\n2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.\n3. Are pregnant or breastfeeding\\*\\*\n4. Are participating in other interventional clinical investigations or have previously participated in this investigation\n5. Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy)\n6. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)\n7. Have a loop ostomy (also called double barrel ostomy)\n8. Have known hypersensitivity towards any of the products used in the investigation\n\n * In DK: women in the child-bearing age will be ask to produce a negative pregnancy test and to sign a form ensuring the use of safe contraception during the investigation.'}, 'identificationModule': {'nctId': 'NCT02675634', 'briefTitle': 'Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy', 'orgStudyIdInfo': {'id': 'CP266'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test A, Test B, Subjects own product', 'description': 'The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Subjects own product']}, {'type': 'EXPERIMENTAL', 'label': 'Test A, Subjects own product, Test B', 'description': 'The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Subjects own product']}, {'type': 'EXPERIMENTAL', 'label': 'Test B, Test A, Subjects own product', 'description': 'The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Subjects own product']}, {'type': 'EXPERIMENTAL', 'label': 'Test B, Subjects own product, Test A', 'description': 'The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Subjects own product']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects own product, Test A, Test B', 'description': 'The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Subjects own product']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects own product, Test B, Test A', 'description': 'The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Subjects own product']}], 'interventions': [{'name': 'Coloplast Test A', 'type': 'DEVICE', 'description': 'Test A is a new 1-piece ostomy appliance developed by Coloplast A/S', 'armGroupLabels': ['Subjects own product, Test A, Test B', 'Subjects own product, Test B, Test A', 'Test A, Subjects own product, Test B', 'Test A, Test B, Subjects own product', 'Test B, Subjects own product, Test A', 'Test B, Test A, Subjects own product']}, {'name': 'Coloplast Test B', 'type': 'DEVICE', 'description': 'Test B is a new 1-piece ostomy appliance developed by Coloplast A/S', 'armGroupLabels': ['Subjects own product, Test A, Test B', 'Subjects own product, Test B, Test A', 'Test A, Subjects own product, Test B', 'Test A, Test B, Subjects own product', 'Test B, Subjects own product, Test A', 'Test B, Test A, Subjects own product']}, {'name': 'Subjects own product', 'type': 'DEVICE', 'description': 'The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.', 'armGroupLabels': ['Subjects own product, Test A, Test B', 'Subjects own product, Test B, Test A', 'Test A, Subjects own product, Test B', 'Test A, Test B, Subjects own product', 'Test B, Subjects own product, Test A', 'Test B, Test A, Subjects own product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Prism research center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '2860', 'city': 'Søborg', 'country': 'Denmark', 'facility': 'TFS', 'geoPoint': {'lat': 56.08481, 'lon': 12.31803}}, {'zip': '9713', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'QPS Netherlands', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': 'B15 2SQ', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Synexus Midlands', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Boston', 'country': 'United Kingdom', 'facility': 'Pilgrim Hospital', 'geoPoint': {'lat': 52.97633, 'lon': -0.02664}}, {'zip': 'Sk11 6TG', 'city': 'Cheshire', 'country': 'United Kingdom', 'facility': 'Illingworth Research Nurses'}, {'zip': 'LN25QY', 'city': 'Lincoln', 'country': 'United Kingdom', 'facility': 'Lincon Country hospital', 'geoPoint': {'lat': 53.22683, 'lon': -0.53792}}, {'zip': 'l9 7AL', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Aintree University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'NN168UZ', 'city': 'Northamptonshire', 'country': 'United Kingdom', 'facility': 'Kettering General hospital'}, {'zip': 'NE46 1QJ', 'city': 'Northumberland', 'country': 'United Kingdom', 'facility': 'Synexus Hexam'}], 'overallOfficials': [{'name': 'Camilla F Vibjerg', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of Clinical Operation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}