Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-03-11 @ 1:03 AM
Study NCT ID:
NCT05419258
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2022-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'feasibility study on medical device'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-06-10', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success in performing dialysis', 'timeFrame': 'one month', 'description': 'Study the feasibility of performing dialysis with the UPlug Technology in patients with a permanent tunneled central venous hemodialysis catheter with the objective of a success rate ≥ 80%.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Adverse Events [Safety and Tolerability] of the experimental device UPLUG', 'timeFrame': 'one month', 'description': 'adverse events reported from consent to end of study'}, {'measure': 'experimental device integrity', 'timeFrame': 'one month', 'description': 'device deficiencies reported from consent to end of study'}, {'measure': "nurses' satisfaction", 'timeFrame': 'one month', 'description': 'satisfaction evaluated by questionnaire before and after the inclusions'}, {'measure': 'patient satisfaction', 'timeFrame': 'one month', 'description': 'satisfaction evaluated by questionnaire before and after the use of experimental device'}, {'measure': 'clinical performance of device', 'timeFrame': 'one month', 'description': 'performance measured by rate of successful sessions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['medical device', 'connection medical device'], 'conditions': ['Hemodialysis', 'Renal Insufficiency, Chronic']}, 'descriptionModule': {'briefSummary': "The new Uplug° technology, interface between the end of the hemodialysis catheter and the dialysis circuit, makes it possible to limit direct access to the hemodialysis catheter during connections and disconnections.\n\nAim:\n\nThe investigators propose a feasibility study, in order to study the new Uplug° technology in real conditions of use.\n\nMaterial and methods:\n\nThis study aim to include 15 hemodialysis patients in a center on a tunneled permanent central venous hemodialysis catheter. The Uplug° technology will be placed at the end of each patient's hemodialysis catheter for a period of one month.\n\nHypothesis tested:\n\nThe main endpoint is the proportion of hemodialysis sessions performed successfully with this technology, respecting the usual dialysis prescription.", 'detailedDescription': "The incidence and prevalence of chronic insufficiency have been growing for several years. Increasingly older patients are treated with chronic hemodialysis. The vascular access of choice remains the arteriovenous fistula and the proportion of hemodialysis patients on the permanent central venous hemodialysis catheter varies from 20 to 35% in dialysis centres. The new Uplug° technology, interface between the end of the hemodialysis catheter and the dialysis circuit, makes it possible to limit direct access to the hemodialysis catheter during connections and disconnections.\n\nAim:\n\nThe investigators propose a feasibility study, in order to study the new Uplug° technology in real conditions of use.\n\nMaterial and methods:\n\nThis study aim to include 15 hemodialysis patients in a center on a tunneled permanent central venous hemodialysis catheter. The inclusion period is three months. The follow-up time for each participant is 6 weeks. Patients with a tunneled permanent central venous hemodialysis catheter and performing dialysis sessions with a flow rate ≥ 300 ml/min may be included. The Uplug° technology will be placed at the end of each patient's hemodialysis catheter for a period of one month.\n\nHypothesis tested:\n\nThe main endpoint is the proportion of hemodialysis sessions performed successfully with this technology, respecting the usual dialysis prescription.\n\nThe secondary objectives are the infectious risk, the defects of the experimental device and the hemodialysis catheter or their implementation, the satisfaction of the nursing staff and the patient, the reduction in the number of manipulations and the effective time of these manipulations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* with end-stage chronic renal failure treated by hemodialysis (2 or 3 sessions per week)\n* Wearer of a right or left jugular permanent tunneled central venous hemodialysis catheter whose end has been in the superior vena cava or the right atrium for at least 1 month\n* Hemodialysis catheter lock used = heparin or 4% citrate\n* Expected life expectancy \\> 6 months\n* Dialysis session preceding inclusion with an average blood flow of at least 300ml/min\n\nExclusion Criteria:\n\n* Patient with a mechanical heart valve\n* Patient with an arteriovenous fistula (AVF) that can be used within one month\n* Kidney transplant by living donor planned in the following month\n* Pregnant or breastfeeding woman\n* History of infection on the hemodialysis catheter in place dating from less than 6 months\n* Psychiatric or demented patient unable to obtain informed consent\n* Patient already included in another protocol'}, 'identificationModule': {'nctId': 'NCT05419258', 'acronym': 'UPLUG-SAFE', 'briefTitle': 'Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device', 'orgStudyIdInfo': {'id': '21-0265'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'use of the device during hemodialysis sessions', 'description': 'use of the device during one month during hemodialysis sessions', 'interventionNames': ['Device: UPLUG Hemodialysis Connection Device']}], 'interventions': [{'name': 'UPLUG Hemodialysis Connection Device', 'type': 'DEVICE', 'description': 'use of the device UPLUG during 1 month', 'armGroupLabels': ['use of the device during hemodialysis sessions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen Normandie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}