Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-25 @ 4:33 PM
Study NCT ID:
NCT03506659
Status:
TERMINATED
Last Update Posted:
2020-02-28
First Post:
2018-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy électrochimique cutanée
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel group open label Monocentric'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4000}}, 'statusModule': {'whyStopped': 'Inclusion rate too low', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-26', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of timing for Electrochemical skin conductance', 'timeFrame': '3 minutes', 'description': 'the investigators will measure the timing between the 4 members for the Electrochemical skin conductance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Difference, Individual']}, 'descriptionModule': {'briefSummary': 'Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers', 'detailedDescription': "Objective: Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers\n\nBackground:\n\nSudoscan is a tool developed to evaluate and screen peripheral neuropathies in diabetes. His indication has been extended to other neuropathies such as post-chemotherapy, Fabry's disease, Parkinson's disease, familial amyloid polyneuropathy.\n\nMain objective: Evaluation of the relevance of cutaneous electrochemical conductance in chronic peripheral neuropathies.\n\nMethodology :\n\nRecruitment of 2 groups of 2000 patients Group 1: Patients with chronic neuropathy, during clinic bread consultation Group 2: Patients to benefit from scheduled surgery seen during anesthesia consultation For both groups filling the central awareness inventory questionnaire\n\nAnalysis of the results after the recruitment has been completed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n\nExclusion Criteria:\n\n* Patients group : Not have a chronic neuropathy'}, 'identificationModule': {'nctId': 'NCT03506659', 'briefTitle': 'Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy électrochimique cutanée', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy', 'orgStudyIdInfo': {'id': 'SUDOKU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Test', 'description': '2000 patients healthy in anesthesiology consultation', 'interventionNames': ['Device: SUDO-SCAN Device']}, {'type': 'EXPERIMENTAL', 'label': 'Patients', 'description': '2000 patients in pain clinic consultation', 'interventionNames': ['Device: SUDO-SCAN Device']}], 'interventions': [{'name': 'SUDO-SCAN Device', 'type': 'DEVICE', 'description': 'Sudo-scan is a machine with 2 palets for hands and 2 palets for foots. The patient has to put his 2 hands and 2 foots on the machine. The machine do the measures during 2 minutes.', 'armGroupLabels': ['Patients', 'Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'ERASME Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Turgay TUNA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Universitaire de Bruxelles (HUB) Erasme'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}