Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT05411666
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance Optimization of the Fully Implanted Venous Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2022-06-06', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events', 'timeFrame': 'Time since screening until follow-up visit (on average 20 months)', 'description': 'The occurrence of any adverse event related to the use of the CVCTI, thus allowing to assess the difference between the 2 groups with as much data as possible.'}], 'secondaryOutcomes': [{'measure': 'Occurence of AE related with infectious complications', 'timeFrame': 'Time since screening until follow-up visit (on average 20 months)', 'description': 'The occurrence of adverse events related to infectious complications in the 2 groups.'}, {'measure': 'Occurence of AE related with thrombotic complications', 'timeFrame': 'Time since screening until follow-up visit (on average 20 months)', 'description': 'The occurrence of adverse events related to thrombotic complications of both CVCTI and venous thrombosis in both groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central venous catheter'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "Central venous catheter (CVC) are intravascular devices used in clinical practice, namely to administer fluid therapy, parenteral nutrition, drugs, blood products, hemodynamic monitoring, also being a gateway to the collection of blood samples or laboratory monitoring.\n\nThe fully implanted central venous catheter (CVCTI) is a type of central venous access surgically placed, which is characterized by containing a subcutaneous reservoir that is accessed by puncturing the camera with a blunt needle, widely used in cancer patients. The fully implanted central venous catheter is recommended when there is a need for intermittent vascular access and of long duration.\n\nThe maintenance of the CVCTI, as it's the necessity, frequency, and method is subject of some controversy, with discrepancies between the various cancer centers and guidance documents, once they occur several different intervals and maintenance methods.\n\nThe objective of this study is to assess the necessity of frequent maintenance of fully implanted central venous catheter, still assuring its viability and holding the same or lower number incidence of complications.\n\nParticipants in this study are cancer patients with a CVC fully implanted for chemotherapy, in follow-up phase. Participants will be randomized in one of two arms: Maintenance with saline solution and no maintenance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Cancer patients, undergoing placement of CVCTI for chemotherapy, in follow-up, who finished chemotherapy up to a maximum period of 10 weeks.\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Evidence of signed and dated informed consent indicating that the patient has been informed of all relevant aspects of the study and agrees to participate.\n\nExclusion Criteria:\n\n* Presence of metastases or any other condition that may be an indication for intravenous treatments or additional chemotherapy regimens\n* History of CVCTI-related adverse events during the treatment phase\n* Patients on anticoagulant medication\n* History of thrombophilia\n* Pregnancy/Breastfeeding'}, 'identificationModule': {'nctId': 'NCT05411666', 'acronym': 'OTIMACAT', 'briefTitle': 'Maintenance Optimization of the Fully Implanted Venous Catheter', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Academic Center (2CA-Braga)'}, 'officialTitle': 'Maintenance Optimization of the Fully Implanted Venous Catheter', 'orgStudyIdInfo': {'id': 'OTIMACAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1', 'description': 'Saline solution maintenance of the Central venous catheter (CVC)', 'interventionNames': ['Procedure: Saline solution maintenance of the CVC']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'No maintenance of the Central venous catheter (CVC)', 'interventionNames': ['Procedure: No maintenance of the CVC']}], 'interventions': [{'name': 'Saline solution maintenance of the CVC', 'type': 'PROCEDURE', 'otherNames': ['Saline solution maintenance'], 'description': 'Saline solution maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B\\|Braun, according to local standard procedures.', 'armGroupLabels': ['Arm 1']}, {'name': 'No maintenance of the CVC', 'type': 'PROCEDURE', 'otherNames': ['No maintenance'], 'description': 'No maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B\\|Braun. Just visual inspection to local site of CVC insertion.', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4710-243', 'city': 'Braga', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Rosana Magalhaes', 'role': 'CONTACT', 'phone': '00351 253 027249'}], 'facility': 'Serviço de Hospital de Dia, Hospital de Braga', 'geoPoint': {'lat': 41.5514, 'lon': -8.42311}}], 'centralContacts': [{'name': 'Rosana Magalhaes', 'role': 'CONTACT', 'email': 'cro@ccabraga.org', 'phone': '+351 253 027 249'}], 'overallOfficials': [{'name': 'Ema Alves', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Serviço de Hospital de Dia, Hospital de Braga, EPE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Academic Center (2CA-Braga)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}