Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-02-20 @ 4:43 PM
Study NCT ID:
NCT02805335
Status:
UNKNOWN
Last Update Posted:
2017-02-01
First Post:
2016-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Sutureless Devices for PICC and a New System KT FIX PLUS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2016-03-17', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morbidity assessed as a composite of:', 'timeFrame': 'from baseline up to 1 year', 'description': '* Catheter infection\n* Symptomatic superficial or deep venous thrombosis\n* Catheter occlusion\n* Premature withdrawal\n* Catheter migration\n* Hematoma occurred within 24 hours after installation in incidence density'}], 'secondaryOutcomes': [{'measure': 'quality of life', 'timeFrame': '1 year', 'description': 'internal satisfaction scale'}, {'measure': 'cost', 'timeFrame': '1 year', 'description': 'direct costs of PICCS fastening systems'}, {'measure': 'efficacy of urokinase', 'timeFrame': '1 year', 'description': 'recanalization rates of PICC after application of urokinase protocol'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Central Venous Catheter', 'Catheter Bloodstream Related Infection', 'Economic evaluation'], 'conditions': ['Catheter Complications', 'Thrombosis', 'Displacement of Infusion Catheter', 'Quality of Life']}, 'descriptionModule': {'briefSummary': "PICC (Peripherally Inserted Central Catheter) are commun used. Just one paper report morbidity with suture as fixation system for PICC (dislodgement, infection) In the guidelines it's recommended to use sutureless device. The devices actually used are unsatisfactory because of the high risk of migration, accidental removal.\n\nA new device, called KTFIX PLUS, seem to be more secure for PICC fixation and offer the possibility to simplify the after care. This device may stay on patient for 4 weeks. Others devices may be changed 1/week.\n\nThe investigators aimed to compare morbidity between this new device and the old one. The investigators also want to perform an economic evaluation of this device and compare patient quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with indication for PICC according guidelines\n* hospitalized in a departement of your hospital\n* with the possibility to use a sutureless device\n\nExclusion Criteria:\n\n* infection\n* thrombosis\n* pediatric patient\n* emergency context'}, 'identificationModule': {'nctId': 'NCT02805335', 'acronym': 'KTFIXPICC', 'briefTitle': 'Comparison Between Sutureless Devices for PICC and a New System KT FIX PLUS', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Comparison Between Actually Sutureless Devices for PICC to a New Device KT FIX PLUS', 'orgStudyIdInfo': {'id': '2014-A01303-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Group with the sutureless device actually used'}, {'type': 'EXPERIMENTAL', 'label': 'Innovative group', 'description': 'Group with the new device ( KTFIX PLUS)', 'interventionNames': ['Device: KTFIX PLUS']}], 'interventions': [{'name': 'KTFIX PLUS', 'type': 'DEVICE', 'armGroupLabels': ['Innovative group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Audrey FOHLEN, MD', 'role': 'CONTACT'}], 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Audrey Fohlen, MD MSc', 'role': 'CONTACT', 'email': 'fohlen-a@chu-caen.fr', 'phone': '+33666577519'}], 'overallOfficials': [{'name': 'Audrey Fohlen, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical and University Center of Caen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}