Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-02 @ 12:48 AM
Study NCT ID:
NCT04912050
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2021-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXtension of Tablo TrEatmeNt Duration Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-12-08', 'releaseDate': '2023-03-03'}], 'estimatedResultsFirstSubmitDate': '2023-03-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-05-28', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Success', 'timeFrame': 'Up to 24 hours', 'description': 'Percentage of treatments achieving prescribed dialysis treatment time ≤ 10%'}], 'secondaryOutcomes': [{'measure': 'Tablo Cartridge Life', 'timeFrame': 'up to 24 hours', 'description': 'Measure the average number of cartridge changes required to complete a Tablo XT Treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Tablo', 'Outset Medical', 'Hemodialysis', 'AKI', 'ESKD'], 'conditions': ['End Stage Renal Disease (ESRD)', 'End Stage Renal Disease on Dialysis', 'Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Observational, retrospective and prospective, multicenter, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \\> 12 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \\> 12 hours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant weighs ≥ 34kg.\n* Participant is hospitalized and has dialysis dependent End-Stage Kidney Disease or Acute Kidney Injury and is prescribed renal replacement therapy \\> 12 hours.\n\nExclusion Criteria:\n\n* Any documented condition that the Physician feels would prevent the participant from successful inclusion in the study.'}, 'identificationModule': {'nctId': 'NCT04912050', 'acronym': 'XTEND', 'briefTitle': 'EXtension of Tablo TrEatmeNt Duration Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Outset Medical'}, 'officialTitle': 'EXtension of Tablo TrEatmeNt Duration Registry (XTEND)', 'orgStudyIdInfo': {'id': '2020-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tablo Hemodialysis System', 'description': 'Hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \\> 12 hours on the Tablo Hemodialysis System', 'interventionNames': ['Device: Tablo Hemodialysis System']}], 'interventions': [{'name': 'Tablo Hemodialysis System', 'type': 'DEVICE', 'description': 'Renal Replacement Therapy between 12\\< to ≤ 24 hours.', 'armGroupLabels': ['Tablo Hemodialysis System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "St. Mark's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only aggregated participant data is planned to be shared at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Outset Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-03-03', 'type': 'RELEASE'}, {'date': '2023-12-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Outset Medical'}}}}