Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:05 PM
Study NCT ID:
NCT01243294
Status:
COMPLETED
Last Update Posted:
2011-10-07
First Post:
2010-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkpialn@coloplast.com', 'phone': '+4549113250', 'title': 'Pia Nordmand, Clinical Trial Manager', 'organization': 'Coloplast A/S'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'AE data where collected from inclusion to the two test periods where completed (~24 days)', 'eventGroups': [{'id': 'EG000', 'title': 'SenSura', 'description': 'Base plates applied 1 till 6 times a day', 'otherNumAtRisk': 54, 'otherNumAffected': 2, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SS (New Ostomy Bag)', 'description': 'Base plates applied 1 till 6 times a day SS = new ostomy bag', 'otherNumAtRisk': 54, 'otherNumAffected': 1, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Redness and skin damage', 'notes': 'Rated as related to medical device. Moderate severity. Device used while experiencing adverse event: SenSura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral lesions from 5 cm (peripheral edges)', 'notes': 'Rated as related to medical device. Moderate severity. Device used while experiencing adverse event: SenSura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness on skin 0-2 cm from stoma edge', 'notes': 'Rated as related to medical device. Mild severity. Device used while experiencing adverse event: SS (new ostomy appliance)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Leakage (Percent of All Base Plates With Leakage)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}, {'units': 'Base plates', 'counts': [{'value': '975', 'groupId': 'OG000'}, {'value': '1046', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'New Adhesive SS', 'description': 'SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}, {'id': 'OG001', 'title': 'SenSura', 'description': 'CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day', 'description': 'Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point', 'unitOfMeasure': 'Percent of Base plates', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Base plates', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Intention to treat. As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'New Adhesive SS', 'description': 'SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}, {'id': 'OG001', 'title': 'SenSura', 'description': 'CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the investigation ~ 24 days per subject', 'description': 'Safety is evaluated by adverse events occuring continues while the subjects are testing the devices', 'unitOfMeasure': 'Adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.\n\nPopulation is ITT', 'anticipatedPostingDate': '2011-03'}, {'type': 'SECONDARY', 'title': 'Security (Subjects Own Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'New Adhesive SS', 'description': 'SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}, {'id': 'OG001', 'title': 'SenSura', 'description': 'CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product', 'description': "Results of participants who answered on own assessment of security on a 5 point scale ('very poor', 'poor', 'acceptable', 'good' and 'very good'). 'Good' and 'very good' are the preferred end points The 'very good' result are presented here.\n\nUnit of measure is: Percentage of participants answering 'very good'", 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.\n\nPopulation is ITT', 'anticipatedPostingDate': '2011-03'}, {'type': 'SECONDARY', 'title': 'Handling at Appliance (Subjects Own Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'New Adhesive SS', 'description': 'SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}, {'id': 'OG001', 'title': 'SenSura', 'description': 'CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product', 'description': "Handling at appliance where evaluated by subjects own assessment on a 5 point scale from very difficult to very easy.\n\nResults of participants who answered on own feeling of handling at appliance on a 5 point scale (very difficult, difficult, acceptable, easy, very easy). Easy and very easy are the preferred end points and it is the these results that are presented here.\n\nUnit of measure is: Percentage of participants answering 'very easy' and 'easy'", 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.\n\nPopulation is ITT', 'anticipatedPostingDate': '2011-03'}, {'type': 'SECONDARY', 'title': 'Comfort (Subjects Own Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'New Adhesive SS', 'description': 'SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}, {'id': 'OG001', 'title': 'SenSura', 'description': 'CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product', 'description': "Comfort where evaluated by subjects own assessment on a 5 point scale from very uncomfortable to very comfortable.\n\nResults of participants who answered on own assessment of comfort of wearing the product on a 5 point scale (very uncomfortable, uncomfortable, acceptable, comfortable, very comfortable). Comfortable and very comfortable are the preferred end points and it is these results that are presented here.\n\nUnit of measure is: Percentage of participants answering 'very comfortable' and 'comfortable'", 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.\n\nPopulation is ITT', 'anticipatedPostingDate': '2011-03'}, {'type': 'SECONDARY', 'title': 'Wear Time (Registered by Subject When Applying and Removing a Product)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}, {'units': 'Base plates', 'counts': [{'value': '975', 'groupId': 'OG000'}, {'value': '1046', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'New Adhesive SS', 'description': 'SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}, {'id': 'OG001', 'title': 'SenSura', 'description': 'CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.46', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '11.41', 'spread': '6.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day', 'description': 'Wear time was calculated from the time the subjects applied their product (date, year, time) to the time they detached the product (date, year, time). Wear time was estimated in hours per subject per base plate and mean value was calculated.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Base plates', 'denomUnitsSelected': 'Participants', 'populationDescription': 'As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.\n\nPopulation is ITT', 'anticipatedPostingDate': '2011-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SenSura First, Then SS', 'description': 'SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.\n\nSenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}, {'id': 'FG001', 'title': 'SS First, Then SenSura', 'description': 'SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.\n\nSenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).\n\nBoth SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.\n\nThe difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.'}], 'periods': [{'title': 'First Intervention (10 Days +/- 2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (10 Days +/- 2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects recruited from a user database in Denmark and through six hospital sites in France between august and november 2010', 'preAssignmentDetails': '56 subject where enrolled, however two subjects did not comply to the in- and exclusion criteria and was hence terminated before testing any devices'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes groups randomized to receive SS (new ostomy bag)first and SenSura first'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '10.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-04', 'studyFirstSubmitDate': '2010-08-09', 'resultsFirstSubmitDate': '2011-02-17', 'studyFirstSubmitQcDate': '2010-11-17', 'lastUpdatePostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-23', 'studyFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leakage (Percent of All Base Plates With Leakage)', 'timeFrame': 'After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day', 'description': 'Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'During the investigation ~ 24 days per subject', 'description': 'Safety is evaluated by adverse events occuring continues while the subjects are testing the devices'}, {'measure': 'Security (Subjects Own Assessment)', 'timeFrame': 'After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product', 'description': "Results of participants who answered on own assessment of security on a 5 point scale ('very poor', 'poor', 'acceptable', 'good' and 'very good'). 'Good' and 'very good' are the preferred end points The 'very good' result are presented here.\n\nUnit of measure is: Percentage of participants answering 'very good'"}, {'measure': 'Handling at Appliance (Subjects Own Assessment)', 'timeFrame': 'After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product', 'description': "Handling at appliance where evaluated by subjects own assessment on a 5 point scale from very difficult to very easy.\n\nResults of participants who answered on own feeling of handling at appliance on a 5 point scale (very difficult, difficult, acceptable, easy, very easy). Easy and very easy are the preferred end points and it is the these results that are presented here.\n\nUnit of measure is: Percentage of participants answering 'very easy' and 'easy'"}, {'measure': 'Comfort (Subjects Own Assessment)', 'timeFrame': 'After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product', 'description': "Comfort where evaluated by subjects own assessment on a 5 point scale from very uncomfortable to very comfortable.\n\nResults of participants who answered on own assessment of comfort of wearing the product on a 5 point scale (very uncomfortable, uncomfortable, acceptable, comfortable, very comfortable). Comfortable and very comfortable are the preferred end points and it is these results that are presented here.\n\nUnit of measure is: Percentage of participants answering 'very comfortable' and 'comfortable'"}, {'measure': 'Wear Time (Registered by Subject When Applying and Removing a Product)', 'timeFrame': 'After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day', 'description': 'Wear time was calculated from the time the subjects applied their product (date, year, time) to the time they detached the product (date, year, time). Wear time was estimated in hours per subject per base plate and mean value was calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colostomy']}, 'descriptionModule': {'briefSummary': 'The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.', 'detailedDescription': 'Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems.\n\nTo protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new ostomy appliance to improve the feeling of security and increase comfort by the appliance characteristics.\n\nThe objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.\n\nThe study is a randomised controlled cross-over intervention study, where all study participants will test two test products (new ostomy appliance and SenSura). Each test period will last 10 ± 2 days and the subjects will follow their usual wear and change pattern. The participants will visit the study investigator at study start and at cross-over. Evaluation of the test products will occur via questionnaires the subjects fill in at home.\n\n50 healthy subjects with a colostomy will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have given written informed consent\n* Be at least 18 years of age and have full legal capacity\n* Be able to handle the bags themselves (application, removal)\n* Have a colostomy with a diameter less than 45 mm\n* Have had a colostomy for at least 3 months\n* Currently use a 1-piece flat ostomy appliance with closed bag\n* is suitable for treatment with a standard adhesive, flat base plate (evaluated by nurse)\n* Use minimum 1 product per day\n* Be willing to test a new Coloplast one-piece custom cut ostomy appliance size midi or maxi for 10 days and SenSura (1- piece open ostomy bag custom cut ostomy appliance) size midi or maxi for 10 days\n* Have the mental capacity to understand the study and questionnaires\n\nExclusion Criteria:\n\n* Use irrigation during the study (flush the stoma with water).\n* Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)\n* Currently receiving or have within the last 2 months received chemotherapy or radiation therapy\n* Currently receive or have within the past three weeks been receiving steroid medication in the peristomal area.\n* Are pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT01243294', 'briefTitle': 'Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort', 'orgStudyIdInfo': {'id': 'CP209OC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SenSura', 'description': 'CE marked and launched (The letters "CE" do not represent any specific words, though may have initially stood for "Communauté Européenne" ("European Community") or "Conformité Européenne" ("European Conformity"). By affixing the CE marking to a product, the manufacturer declares that it meets EU safety and health and environmental requirements.', 'interventionNames': ['Device: SS', 'Device: SenSura']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'New ostomy appliance (SS)', 'description': 'SS = New ostomy appliance. Due to company confidentiality the product is just called SS and this is not short for any other names.', 'interventionNames': ['Device: SS', 'Device: SenSura']}], 'interventions': [{'name': 'SS', 'type': 'DEVICE', 'otherNames': ['SenSura', 'New ostomy appliance'], 'description': 'New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.', 'armGroupLabels': ['New ostomy appliance (SS)', 'SenSura']}, {'name': 'SenSura', 'type': 'DEVICE', 'otherNames': ['New ostomy appliance'], 'description': 'New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.', 'armGroupLabels': ['New ostomy appliance (SS)', 'SenSura']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Humlebæk', 'country': 'Denmark', 'facility': 'Coloplast A/S', 'geoPoint': {'lat': 55.9618, 'lon': 12.5341}}], 'overallOfficials': [{'name': 'Pia Nordmand, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Coloplast A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}