Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT03990818
Status:
UNKNOWN
Last Update Posted:
2019-09-23
First Post:
2019-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Registration of Bioimpedance During Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-12-09', 'releaseDate': '2021-11-11'}, {'resetDate': '2022-03-04', 'releaseDate': '2021-12-13'}, {'resetDate': '2022-07-21', 'releaseDate': '2022-03-23'}], 'estimatedResultsFirstSubmitDate': '2021-11-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2019-06-17', 'studyFirstSubmitQcDate': '2019-06-17', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of patch performance', 'timeFrame': 'August - December 2019', 'description': 'Establish sensitivity and specificity of patch performance relative to extracted water, weight change and blood sample results'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dialysis Related Complication', 'Dehydration']}, 'descriptionModule': {'briefSummary': 'This studies aims at testing continuous registration of bioimpedance during hemodialysis and comparing the measurement with extracted liquid.', 'detailedDescription': 'The purpose is to test the sensitivity and specificity of a new electronic patch in the indication of the relative change in the fluid balance. If possible, the change in hydration level should be quantified. The test is done on patients during hemodialysis. Extracted amount of fluid is used as the primary reference to the bioimpedance measurements, but other references will also be used.\n\nThe measurement is made using bioimpedance measured with four electrodes and over a large frequency spectrum. Impedance measurements are made every 20 seconds throughout the test period. The measurement is recorded in a memory (flash) on each patch. At the same time as measuring bioimpedance, the temperature in the patch is recorded.\n\nAfter completion of the test, the data is transferred to a computer for analysis. As a reference, extracted amount of fluid, weight change, blood samples and clinical evaluation are used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients for hemodialysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients for hemodialysis\n\nExclusion Criteria:\n\n* Acute in-current disease.\n* Known adverse reaction to medical adhesive'}, 'identificationModule': {'nctId': 'NCT03990818', 'acronym': 'DELAGE', 'briefTitle': 'Continuous Registration of Bioimpedance During Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mode Sensors AS'}, 'officialTitle': 'Continuous Registration of Bioimpedance During Hemodialysis', 'orgStudyIdInfo': {'id': '2019 DELAGE'}}, 'contactsLocationsModule': {'locations': [{'city': 'Levanger', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Carl Platou', 'role': 'CONTACT', 'email': 'carl.platou@helse-nordtrondelag.no'}, {'name': 'Solfrid Romundstad', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Levanger Hospital', 'geoPoint': {'lat': 63.74644, 'lon': 11.29963}}], 'centralContacts': [{'name': 'Jørn Kværness', 'role': 'CONTACT', 'email': 'jorn@modesensors.com', 'phone': '+4795089723'}], 'overallOfficials': [{'name': 'Magnus Nordahl', 'role': 'STUDY_CHAIR', 'affiliation': 'Mode Sensors AS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mode Sensors AS', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-11-11', 'type': 'RELEASE'}, {'date': '2021-12-09', 'type': 'RESET'}, {'date': '2021-12-13', 'type': 'RELEASE'}, {'date': '2022-03-04', 'type': 'RESET'}, {'date': '2022-03-23', 'type': 'RELEASE'}, {'date': '2022-07-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mode Sensors AS'}}}}