Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-19 @ 3:01 AM
Study NCT ID:
NCT01977157
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2013-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alcohol Detection Via Bioimpedance Mesurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2013-10-30', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioimpedance measurements', 'timeFrame': '4 hours', 'description': 'Evaluation if the bioimpedance measurements can be used to verify and quantify the alcohol content in human blood. Bioimpedance measurements will be conducted with the BIS device (SFB7, ImpediMed) covering a frequency range between 5 kHz and 1 MHz and an ICG device (Niccomo,medis) operating at. The whole-body and hand-to-hand bioimpedance will be analyzed. Extracellular resistance (Re), intracellular resistance (Ri) and capacitive effects (Cm) are calculated by using the Cole model Grimnes (2000).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Impedance cardiography', 'bioimpedance', 'spectroscopy', 'extracellular resistance', 'body composition', 'hemodynamics', 'alcohol'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Examination if the bioimpendanz measurement can be used for the determination of the alcohol content in human blood.\n\nFurthermore the blood alcohol content (BAC) will be estimated by an official breathalyzer and one blood test.', 'detailedDescription': 'In this clinical trail it will be analyzed, if it is possible to assess the blood alcohol content (BAC) with the bioimpedance devices (SFB7, ImpediMed; Nicomo).\n\nThis technology is non-invasive an can be measured by using conductive electrodes, capacitive electrodes or inductive measurement systems.\n\nThe BIS-values will be compared with an official breathanalyzer (Alcotest 7110 Evidential MK III, Dräger, Lübeck, Germany).\n\nFurthermore one blood sample will be taken and analyzed with the ADH method as the current gold standard at the end of the trail.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy male subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects\n* able to give informed consent\n* Inconspicuous laboratory and drug screening\n\nExclusion Criteria:\n\n* electrophobica\n* alcoholphobica, -allergy\n* metallic ans / or electric implants\n* underage persons\n* interactively medication'}, 'identificationModule': {'nctId': 'NCT01977157', 'acronym': 'AlkBIS', 'briefTitle': 'Alcohol Detection Via Bioimpedance Mesurements', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Alcohol Detection Via Bioimpedance Mesurements', 'orgStudyIdInfo': {'id': '11-189'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bioimpedance measurements while trinking alcohol', 'description': 'Bioimpedance spectroscopy (BIS) measurements on 12 healthy subjects were performed while they were drinking alkohol until reaching a BAC of 0.8 ‰.', 'interventionNames': ['Device: bioimpedance mesurements']}], 'interventions': [{'name': 'bioimpedance mesurements', 'type': 'DEVICE', 'description': 'Bioimpedance measurements were conducted with a BIS device (SFB7, ImpediMed, Pinkeba, Australia) covering a frequency range between 5 kHz and 1 MHz and an ICG device (Niccomo, medis, Ilmenau, Germany)', 'armGroupLabels': ['bioimpedance measurements while trinking alcohol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Anaesthesiology, University Hospital Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Michael Czaplik, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology ,Chair for Medical Information Technology Helmholtz Institute for Biomedical Engineering RWTH Aachen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}