Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-27 @ 2:26 AM
Study NCT ID:
NCT07034092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PATH-03 Paraguay Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D005402', 'term': 'Fistula'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'An endoAVF for dialysis access will be created in the treated subjects.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Endpoint', 'timeFrame': '3 months', 'description': 'Proportion of patients that experience one or more serious ePATH device-related or ePATH portion of the procedure-related adverse events during the first 3 months following AVF creation.'}], 'secondaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': '7 days', 'description': 'Technical success: Successful creation of a fistula with the ePATH system. Verification that an endoAVF has been created with the ePATH system and that it remains patent 1-7 days after the index procedure. Patency will be defined by an experienced examiner as the presence of a bruit as detected by stethoscope, or the presence of a thrill, or with duplex ultrasonography for all study endpoints.'}, {'measure': 'AVF maturation', 'timeFrame': '3 months', 'description': 'Defined as an AVF that is free from stenosis or thrombosis with an arterial inflow of at least 500 ml/min and/or a diameter of at least 4 mm (as measured by duplex ultrasonography) or the patient was successfully dialysed with 2 needles.'}, {'measure': 'Time to fistula maturation', 'timeFrame': '3 months', 'description': 'Number of days between the index procedure and the date at which AVF maturation is achieved'}, {'measure': 'Rate of other device or other procedure-related adverse events', 'timeFrame': '3 months', 'description': 'Rate of serious other device (not ePATH device) or other procedure-related (not ePATH portion of the procedure) adverse events at 3 months following the index procedure'}, {'measure': 'Rate of device and/or procedure related infections', 'timeFrame': '3 months', 'description': 'Rate of device and/or procedure related infections at 3 months following the index procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fistula, AVF, endoAVF, hemodialysis, vascular access', 'endovascular AVF'], 'conditions': ['Kidney Disease, End-Stage']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the safety and effectiveness of the ePATH system in the creation of an endovascular AVF (endoAVF) in patients who require or will soon require hemodialysis and are eligible for a fistula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients deemed eligible for creation of an AV fistula according to institutional or local guidelines and/or clinical judgement of the investigator\n2. Adults (age \\>18 years old)\n3. Non-reversible kidney failure requiring hemodialysis (this can include pre-dialysis patients)\n4. Target vein diameter of ≥2.0 mm\n5. Target artery diameter of ≥2.0 mm\n6. Both radial and ulnar artery flow to the hand, confirmed with Duplex Ultrasound and/or Allen's test (i.e. palmar arch)\n7. Able to provide informed consent\n8. Able to comply with follow-up visit assessment requirements\n9. Patient is free from clinically significant conditions or illnesses that might compromise the procedure or the AVF\n\nExclusion Criteria:\n\n1. Significant central venous stenosis or narrowing that exceeds 50% based on imaging\n2. Hypercoagulable state or known bleeding diathesis\n3. NHYA Class III or IV heart failure\n4. Estimated life-expectancy of \\<1 year based on the physician's opinion\n5. Oedema of extremities\n6. Current diagnosis of carcinoma\n7. Pregnant or breastfeeding women\n8. Diagnosed or suspected skin disease at the access site\n9. Immunosuppression or otherwise immunocompromised patients\n10. Currently being treated with another investigational device or medication\n11. Allergy to contrast or other drugs associated with surgery, e.g., sedation agents, or to device materials\n12. Anatomy that prevents formation of AVF, e.g., misalignment of vessels or tortuosity\n13. Patient is unwilling to undergo 2nd stage procedure, e.g. endovascular prothesis placement or balloon dilatation, if required"}, 'identificationModule': {'nctId': 'NCT07034092', 'briefTitle': 'PATH-03 Paraguay Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pathfinder Medical'}, 'officialTitle': 'Feasibility Study to Evaluate the Safety and Efficacy of the ePATH System for endoAVF Creation', 'orgStudyIdInfo': {'id': 'SKL-TF60000 10.4'}, 'secondaryIdInfos': [{'id': 'Pathfinder Medical', 'type': 'OTHER', 'domain': 'The study is funded only by Pathfinder Medical and is not listed in any other databases.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'An endoAVF will be created in the treated subjects.', 'interventionNames': ['Device: ePATH System will be used to create an endoAVF']}], 'interventions': [{'name': 'ePATH System will be used to create an endoAVF', 'type': 'DEVICE', 'description': 'An endoAVF will be created in subjects that need fistulas for hemodialysis', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '001207', 'city': 'Asunción', 'country': 'Paraguay', 'contacts': [{'name': 'Adrian A Ebner, MD', 'role': 'CONTACT', 'email': 'adrian@ebner.com.py', 'phoneExt': '+595 21 214 26'}, {'name': 'Adrian A Ebner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sanatorio Italiano', 'geoPoint': {'lat': -25.28646, 'lon': -57.647}}], 'centralContacts': [{'name': 'Sorin C Popa, BESc, MRes', 'role': 'CONTACT', 'email': 'sorin@pathfindermed.com', 'phone': '+44 (0) 7939186529'}], 'overallOfficials': [{'name': 'Adrian A Ebner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sanatorio Italiano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pathfinder Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MINSA SA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}