[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521011":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":49,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":18,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":18,"enrollmentInfo":61,"targetDuration":18,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"SciBase AB","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Nevisense","This will be a prospective investigator-initiated study to evaluate the accuracy of Nevisense for KC. First evaluation steps include dermatologist's clinical examination (visual inspection) and videodermoscopy. In those cases where the routine diagnostic procedures given above identify any suspicion of a KC, a Nevisense measurement is to be conducted after examination of inclusion and exclusion criteria. Thereafter, surgical excision and histopathologic examination follow.\n\nAll skin lesions with a suspicion of BCC, iSCC, BD or AK and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study. A maximum of three lesions per patient will be allowed for the study. The study aims to enrol 250 lesions in total.",[12],"Device: Nevisense",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"DEVICE","The Nevisense system is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Since skin tissues have different electrical properties depending on cell structure and medical conditions, the resulting electrical impedance spectra will reflect the properties of the skin tissue.",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Thomas Dirschka, Prof. Dr. med.","CentroDerm GmbH","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Per Svedenhag","CONTACT","+46 8410 620 01","per.svedenhag@scibase.com",[31],{"facility":32,"status":33,"city":34,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"CentroDerm","RECRUITING","Wuppertal","Germany","DE",{"type":38,"coordinates":39},"Point",[40,41],7.14816,51.25627,{"lat":41,"lon":40},[44,46],{"name":45,"role":23,"phone":18,"phoneExt":18,"email":18},"Thomas Dirschka, Prof.Dr.med.",{"name":47,"role":48,"phone":18,"phoneExt":18,"email":18},"Lutz Schmitz, Priv.-Doz.Dr.med","SUB_INVESTIGATOR",{"type":23,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":22,"oldNameTitle":18,"oldOrganization":18},"Thomas Dirschka","Prof Dr","100521011","evaluation-of-nevisense-as-support-tool-for-the-diagnose-of-keratinocyte-skin-cancer-100521011",false,"NCT06064019","Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer","Evaluation of the Clinical Utility of a New Diagnostic Support Tool, Based on Electrical Impedance Spectroscopy (NEVISENSE), for Keratinocyte Skin Cancer","Inclusion Criteria:\n\n* All male or female patients of any ethnicity, ≥ 18 years with skin lesions of a clinical uncertain diagnosis suspicious for KC (such as BCC, iSCC, BD or AK)\n\nExclusion Criteria:\n\n* Metastases of recurrent lesions\n* Lesion located on acral skin, e.g. sole or palm\n* Lesion located on areas of scars, crusts, psoriasis or similar skin conditions\n* Lesion on hair-covered areas, e.g. scalp, beards, moustaches\n* Lesion located on genitalia\n* Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized\n* Lesion located on mucosal surfaces\n* Lesion with foreign matter, e.g. tattoo or splinter\n* Lesion and \u002F or reference located on acute sunburn\n* Skin surface not measurable, e.g. lesion on a stalk\n* Skin surface not accessible, e.g. inside ears, under nails","ALL","18 Years",{"count":62,"type":63},150,"ESTIMATED","INTERVENTIONAL",[66],"NA","This is a prospective study to assess efficacy of the Nevisense device in identifying keratinocyte skin cancer (KC) in patients suspected of having skin cancer based on the initial physician's assessment.\n\nAll skin lesions with a suspicion of Basal cell carcinoma (BCC), Invasive Squamos cell Carcinoma (iSCC), Bowen's disease (BD) or actinic keratosis (AK) and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study.",[69],"Keratinocyte Skin Cancer",[71],"Electrical Impedance Spectroscopy","2024-12-06",{"date":74,"type":75},"2024-12-11","ACTUAL",{"date":77,"type":75},"2023-07-13",{"date":79,"type":63},"2025-02",{"name":5,"class":6},1]