Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-15 @ 11:06 PM
Study NCT ID:
NCT01833156
Status:
COMPLETED
Last Update Posted:
2013-06-11
First Post:
2013-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the MoistureMeterD in Local Edema by Histamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-09', 'studyFirstSubmitDate': '2013-03-27', 'studyFirstSubmitQcDate': '2013-04-15', 'lastUpdatePostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of edema formation measured with a moisturemeterD of histamin reaction', 'timeFrame': 'october 2013', 'description': 'At various moments and regions around the scratch location the dielectric constant values of the skin is measured in all patients. we try to see if there is a reproducibility of edema with a standardized edema formation method.'}], 'secondaryOutcomes': [{'measure': 'validation of a Moisturemeter device for inter- and intra observer variability', 'timeFrame': 'october 2013', 'description': 'The researchers are randomized in investigator A and B. In several patients at one time three measures are made: A1 and A2 and B. By collecting these data we can calculate the intra-observer variability (A1 versus A2) and the inter observer variability (A1/2 versus B)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['local edema', 'dielectric constant values', 'validation study'], 'conditions': ['Lymphedema']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nijsmellinghe.nl', 'label': 'General website from the Nij Smellinghe hospital'}, {'url': 'http://www.slcn.nl', 'label': 'The foundation related to the expert centre organizing research'}]}, 'descriptionModule': {'briefSummary': 'In lymphedema there is increase in water content of the tissue. We studied a device (MoistureMeterD) which is suitable to detect water contact in the tissue. Although the apparatus is commercially available, no validation study had been performed in vivo with local edema.\n\nWe designed a validation study for inter- and intra observer variability and the reproducibility in vivo by histamin induced local edema', 'detailedDescription': 'The multiprobe Delfin MoistureMeterD is a unique and compact water-specific instrument for the measurement of water content of biological tissues. It measures the dielectric constant values of the skin and subcutaneous tissues non-invasively and locally in a few seconds. The dielectric constant value is directly proportional to the amount of water in the tissue.\n\nAs lymphedema produces local water content increase, we are interested if the device is suitable for daily use in lymphedema patients. Therefore we designed a protocol to measure the results with a moisturemeter in a standardized edema formation by histamin induced scratch test edema. This method is well known in type I allergy testing.\n\nThe aim of the study is:\n\n1. research the inter- and intra observer variability\n2. measure the reproducibility of edema formation in a standardized edema formation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years or older;\n* Coming for intra-cutaneous allergy scratch test;\n* Gender: male and female.\n\nExclusion Criteria:\n\n* Patients who have a pacemaker or other inbuilt stimulator;\n* Lymphoedema;\n* Patients who have an infection;\n* Patients with skin problems in research area.\n* No use of anti-histamines medication'}, 'identificationModule': {'nctId': 'NCT01833156', 'briefTitle': 'Validation of the MoistureMeterD in Local Edema by Histamine', 'organization': {'class': 'OTHER', 'fullName': 'Nij Smellinghe Hosptial'}, 'officialTitle': 'A Clinimetric Research to Test the Validity of the MoistureMeterD, Conducted by the Local Edema (Urticaria Acuta) Into the Administering of Intradermal Histamine.', 'orgStudyIdInfo': {'id': 'NS5NL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient with local edema by histamin', 'description': 'Measuring at 3 locations (on the histmin spot, at 5 cm and 10 cm border (is the control) at 7 times: T0 - T10 minutes - T20 - T30 - T45 - T60 - T75', 'interventionNames': ['Device: MoistureMeterD']}], 'interventions': [{'name': 'MoistureMeterD', 'type': 'DEVICE', 'description': 'measuring erythema size and the dielectric constant values', 'armGroupLabels': ['patient with local edema by histamin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9202 NN', 'city': 'Drachten', 'state': 'Provincie Friesland', 'country': 'Netherlands', 'facility': 'Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital', 'geoPoint': {'lat': 53.11254, 'lon': 6.0989}}], 'overallOfficials': [{'name': 'Robert J Damstra, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nij Smellinghe Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nij Smellinghe Hosptial', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dermatologist MD PhD', 'investigatorFullName': 'R.J. Damstra', 'investigatorAffiliation': 'Nij Smellinghe Hosptial'}}}}