Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-28 @ 7:58 PM
Study NCT ID:
NCT03108105
Status:
COMPLETED
Last Update Posted:
2018-04-24
First Post:
2017-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-23', 'studyFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of efficacy in terms of stool collection and leakage prevention', 'timeFrame': 'At least 1 time per day during 14±3 days', 'description': 'After each change of the investigational product, the patient will describe on a 4-point scale the type of capsule cap cover removal'}, {'measure': 'Description of efficacy in terms of stool collection and leakage prevention', 'timeFrame': 'At least 1 time per day during 14±3 days', 'description': 'After each change of the investigational product, the patient will describe on a 4-point scale the level of leakage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colostomy Stoma']}, 'descriptionModule': {'briefSummary': 'The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is at least 18 years old\n* Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches\n* Patient having a colostomy for at least 1 month\n* Patient using a flat ostomy appliance\n* Patient having a stoma protusion smaller than or equal to 1.5 cm\n* Patient capable to apply and remove the appliance himself or with the help of a caregiver (except health care professional)\n* Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)\n* Patient agreeing to test the new appliance during the evaluation phase (14±3 days)\n* Patient covered by social security\n\nExclusion Criteria:\n\n* Patient experiencing repeated leakages with the usual pouching system\n* Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)\n* Patient receiving or having received, within the last month, chemotherapy, radiotherapy or corticotherapy\n* Patient already participating in another clinical study or who have previously participated in this investigation\n* Pregnant or breast-feeding woman'}, 'identificationModule': {'nctId': 'NCT03108105', 'briefTitle': 'Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'BBraun Medical SAS'}, 'officialTitle': 'Multicenter Pilot Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy', 'orgStudyIdInfo': {'id': 'OPM-G-H-1604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AOS-C2001-B', 'description': 'A new 2-piece appliance composed with 2 parts: a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day)', 'interventionNames': ['Device: AOS-C2001-B']}], 'interventions': [{'name': 'AOS-C2001-B', 'type': 'DEVICE', 'description': 'A new 2-piece appliance composed with 2 parts: a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day)', 'armGroupLabels': ['AOS-C2001-B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78100', 'city': 'Poissy', 'country': 'France', 'facility': 'Elie CHOUILLARD', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BBraun Medical SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}