Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-24 @ 5:26 AM
Study NCT ID:
NCT07194395
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005402', 'term': 'Fistula'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Endpoints - Assessment of device related AEs', 'timeFrame': 'Up to 12 months', 'description': 'Assessment of device related AEs'}, {'measure': 'Exploratory Endpoints - AV access data collection', 'timeFrame': 'Up to 12 months', 'description': "Data collected in the study will be used to train PatenSee system's ability to alert on stenosis and other signs of AV access dysfunction processes."}], 'primaryOutcomes': [{'measure': 'Comparison of "Look" assessment with PatenSee\'s relevant output', 'timeFrame': '6 weeks per patient', 'description': "Agreement between the ability to detect AV access structure parameters by PatenSee's images and the ability to detect the same parameters by clinical monitoring"}, {'measure': 'Comparison of "Listen & Feel" assessments with PatenSee\'s relevant output', 'timeFrame': '6 weeks per patient', 'description': 'Agreement between the PatenSee audio analysis of the AV access bruit and the sound recording of the AV access using a standard digital stethoscope measured'}], 'secondaryOutcomes': [{'measure': 'Functionality endpoint - Average time to conduct PatenSee scanning data capture', 'timeFrame': 'Up to 12 months', 'description': 'Average time to conduct PatenSee scanning data capture'}, {'measure': 'Functionality endpoint - Proportion (%) of participants on whom the PatenSee was used as planned', 'timeFrame': 'Up to 12 months', 'description': 'Proportion (%) of participants on whom the PatenSee was used as planned'}, {'measure': 'Functionality endpoint - Average number of weeks participants obtained PatenSee measurements', 'timeFrame': 'Up to 12 months', 'description': 'Average number of weeks participants obtained PatenSee measurements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nephrology', 'AV access', 'Clinical monitoring of AV access', 'Fistula', 'AV graft'], 'conditions': ['Hemodialysis', 'Clinical Assessment']}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-interventional, single arm, international multicenter study in which up to 120 adult participants with kidney failure requiring regular hemodialysis through arteriovenous (AV) access (AV fistula or graft) will be recruited and evaluated using the PatenSee system.\n\nData captured on the PatenSee system will be analyzed and evaluated against standard of care clinical monitoring of AV accesses.', 'detailedDescription': 'For eligible participants, a clinical exam of the AV access ("Look, Listen, Feel") per SOC will be done by a qualified site clinician/nurse, followed by an assessment of the AV access using the PatenSee system on a weekly basis for 6 weeks, and then biweekly up to 1 year from enrollment. Additional data regarding imaging and complications of the AV access will be collected. Clinical decisions, such as referrals for further investigation and management of the AV access will be based solely on standard clinical monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary dialysis clinics', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female adult patient aged ≥18 years old\n2. Patient has a non-reversible kidney failure that requires long-term hemodialysis\n3. Patient has a functioning AV access (AVF/G) in the upper extremity\n4. Patient is able and willing to provide consent by signing an EC/IRB approved informed consent form\n5. Patient is willing and able to follow the requirements of the study\n\nExclusion Criteria:\n\n1. An active AV access infection\n2. An AV access condition that will likely require revision, e.g., symptomatic steal syndrome\n3. Expected to recover kidney function, receive a kidney transplant, transfer to peritoneal dialysis (PD) or transfer to non-study site during the study period.\n4. Any reason per investigator's discretion for which the patient is not suitable for the study\n5. Any medical or psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to adhere to study requirements\n6. Previous participation in an interventional study within 30 days prior to study enrollment that may interfere with evaluation of the study endpoints\n7. Female patient is pregnant or breastfeeding"}, 'identificationModule': {'nctId': 'NCT07194395', 'briefTitle': 'Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'PatenSee Ltd.'}, 'officialTitle': 'A Prospective International Multicenter, Non-Interventional, Single Arm, Blinded Feasibility Study to Assess the Contactless Optical Monitoring of AV Access Using the PatenSee System in Dialysis Patients', 'orgStudyIdInfo': {'id': 'CMAP-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AVF/G access', 'description': 'Patients with AV access (AVF/G) undergoing hemodialysis', 'interventionNames': ['Device: PatenSee System']}], 'interventions': [{'name': 'PatenSee System', 'type': 'DEVICE', 'description': 'Contactless AV access monitoring device', 'armGroupLabels': ['AVF/G access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lalathaksha Kumbar, MD', 'role': 'CONTACT', 'email': 'lkumbar1@hfhs.org', 'phone': '3139162711'}, {'name': 'Lalathaksha Kumbar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '4428164', 'city': 'Kfar Saba', 'state': 'Hasharon', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Site contact', 'role': 'CONTACT', 'email': 'mekerenben@clalit.org.il', 'phone': '+97297471889'}, {'name': 'Irina Kenis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Naama Barel', 'role': 'CONTACT', 'email': 'Naama.b@patensee.com', 'phone': '972-508341678'}, {'name': 'Adi Bigger Hoggeg', 'role': 'CONTACT', 'email': 'Adi.h@patensee.com', 'phone': '972-544708066'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PatenSee Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}