Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT06581393
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2024-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-08-29', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single-Pool Standardized Dialysis Adequacy', 'timeFrame': 'Samples will be collected before and after each dialysis treatment at Visit 1, Visit 2, Visit 3 and at Visit 4 over a two week period', 'description': "Single-pool standardized dialysis adequacy (spKt/V) will be measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. spKt/V values of ≥ 1.2 are regarded as being adequate."}, {'measure': 'Changes in Blood Chemistry', 'timeFrame': 'Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period', 'description': 'Changes in overall blood chemistry laboratory levels from Visit 1 to Visit 4.'}, {'measure': 'Changes in Complete Blood Count', 'timeFrame': 'Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period', 'description': 'Changes in overall complete blood count levels from Visit 1 to Visit 4.'}, {'measure': 'Changes in Iron Studies', 'timeFrame': 'Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period', 'description': 'Changes in overall iron studies levels from Visit 1 to Visit 4.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['End Stage Renal Disease', 'End Stage Renal Disease on Dialysis', 'End Stage Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This is a non-significant risk study utilizing a device cleared for use by the FDA under its 510(k) clearance. Consented patients will complete their usual dialysis treatment under professional care in an ICHD (In-Center Hemodialysis) setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to consent.\n* Must sign the informed consent and a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.\n* Understand the nature of the procedures and the requirements of the Study.\n\nExclusion Criteria:\n\n* Have a significant cognitive impairment that would preclude informed consent or the capacity for completing dialysis as prescribed by their treating nephrologist.\n* In the opinion of the treating nephrologist, any other reason in which study participation would result in undue risk, including but not limited to protocol required prescription parameters.\n* Are contraindicated for or not indicated to use the Moda-flx Hemodialysis System™ according to the Instructions For Use (IFU).'}, 'identificationModule': {'nctId': 'NCT06581393', 'briefTitle': 'First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings', 'organization': {'class': 'INDUSTRY', 'fullName': 'Diality Inc.'}, 'officialTitle': 'First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings', 'orgStudyIdInfo': {'id': 'DIA-NSR-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Professional Care in an In-Center Hemodialysis Setting', 'description': 'Hemodialysis using the Moda-flx Hemodialysis System', 'interventionNames': ['Device: Moda-flx Hemodialysis System']}], 'interventions': [{'name': 'Moda-flx Hemodialysis System', 'type': 'DEVICE', 'description': 'All participants will complete up to 4 dialysis treatments on the Moda-flx Hemodialysis System over a period of up to 2 weeks.', 'armGroupLabels': ['Professional Care in an In-Center Hemodialysis Setting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91762', 'city': 'Ontario', 'state': 'California', 'country': 'United States', 'facility': 'North America Research Institute', 'geoPoint': {'lat': 34.06334, 'lon': -117.65089}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diality Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}