Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-01-10 @ 2:50 AM
Study NCT ID:
NCT05381961
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2022-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of BIS in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BIS correlation with amount of fluid dialyzed', 'timeFrame': '12 hemodialysis sessions (over 4 to 6 weeks)', 'description': 'BIS-measured fluid change (volume) will be analyzed for correlation with the volume of fluid removed during hemodialysis as documented on dialysis treatment records.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Kidney Failure, Chronic', 'Renal Failure Chronic', 'Hemodialysis']}, 'descriptionModule': {'briefSummary': 'This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.', 'detailedDescription': 'This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis. If changes in BIS parameters correlate with changes in fluid volume and patient symptoms, BIS may help provide a non-invasive way to estimate the amount of fluid to dialyze during a hemodialysis session. Data from this study may be used to inform the design of a future interventional trial of BIS use in hemodialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (aged 18+ years) with end-stage renal disease, are known to a study investigator, and undergo hemodialysis 3-times per week at an outpatient dialysis unit.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age \\>=18 years of age;\n2. End-stage renal disease with a GFR \\<15 mL/min/1.73m\\^2 and dialysis dependent requiring 3-times weekly dialysis;\n3. Able and willing to remove shoes and stand on SOZO for BIS measurements;\n4. Able to provide written informed consent and authorization to use and disclose health information.\n\nExclusion Criteria:\n\n1. Is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion;\n2. Has a clinical condition that would not allow them to complete the study;\n3. Is pregnant or planning to become pregnant; women of childbearing potential (or premenopausal) must be on 2 forms of contraception;\n4. Is lactating;\n5. Has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator);\n6. Has an amputation of a limb/s resulting in them being unable to make contact with the SOZO electrodes (amputations of fingers and toes are not an exclusion);\n7. Patient determined by the attending physician unlikely to be compliant with study procedures."}, 'identificationModule': {'nctId': 'NCT05381961', 'briefTitle': 'Observational Study of BIS in Hemodialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImpediMed Limited'}, 'officialTitle': 'Observational Study of Bioimpedance Spectroscopy (BIS) for Use in a Renal Population', 'orgStudyIdInfo': {'id': 'IPD-ESRD-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stable hemodialysis regimen', 'description': 'Up to 50 patients on hemodialysis \\>6 months, with stable target/dry weight, and have not been hospitalized recently', 'interventionNames': ['Device: Bioimpedance spectroscopy (BIS) measurement, SOZO device']}, {'label': 'Unstable hemodialysis regimen', 'description': 'Up to 20 patients who have been on hemodialysis \\<6 months, or have unintended weight loss/gain, or have recently been hospitalized', 'interventionNames': ['Device: Bioimpedance spectroscopy (BIS) measurement, SOZO device']}], 'interventions': [{'name': 'Bioimpedance spectroscopy (BIS) measurement, SOZO device', 'type': 'DEVICE', 'description': 'All patients enrolled in this study will undergo BIS measurement before and after 12 hemodialysis sessions (pre-dialysis and post-dialysis BIS measurements for each session). Measurements are not provided to treating physicians and are not used to guide clinical decisions; i.e., BIS measurements are collected for observational purposes only.', 'armGroupLabels': ['Stable hemodialysis regimen', 'Unstable hemodialysis regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Balboa Research - Kearny Mesa', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92127', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Balboa Research - Rancho Bernardo', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Mark Boiskin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balboa Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImpediMed Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'California Institute of Renal Research', 'class': 'OTHER'}, {'name': 'Frenova Renal Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}