[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573965":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":79,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Istituto Oncologico Veneto IRCCS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"electrochemotherapy","EXPERIMENTAL","Patients who meet the inclusion criteria will undergo percutaneous, laparoscopic or laparotomy lesion electrochemotherapy within 30 days from the time of obtaining informed consent for study participation (T0), during pre-surgery visit.The ECT will be performed in accordance with the Standard Operating Procedures (SOPs).During the first month after treatment, the patient's response will be assessed every 2 weeks, and thereafter, once a month for a total of 12 months.",[13],"Device: percutaneous, laparoscopic or laparotomy lesion electrochemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","percutaneous, laparoscopic or laparotomy lesion electrochemotherapy","All patients will receive Bleomycin intravenously with a dosage of 15.000 IU\u002Fm2. After a drug distribution time of 8 minutes, the lesions will be electroporated using the Cliniporator (IGEA S.P.A., Carpi, Italy), applying special handpieces depending on the route used: laparoscopic electrode, flexible and expandable for the laparoscopic procedure, linear or hexagonal electrode for laparotomy surgical access, variable geometry electrode for percutaneous access. The ECT procedure must be completed within 40 minutes.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Francesco Russano, MD","CONTACT","049 8211693","francesco.russano@iov.veneto.it",[28],{"facility":29,"status":30,"city":31,"state":20,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Istituto Oncologico Veneto","RECRUITING","Padova","35128","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],11.14261,44.38225,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[46],{"name":47,"class":48},"IGEA","INDUSTRY","100573965","electrochemotherapy-ect-in-patients-with-primary-visceral-tumors-andor-secondary-visceral-localizations-of-any-histotype-100573965",false,"NCT06753136","Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and\u002For Secondary Visceral Localizations, of Any Histotype","Treatment of Visceral Localizations With Electrochemotherapy in Patients With Primary Visceral Tumors and\u002For Secondary Visceral Localizations, of Any Histotype: Monocenter, Single Arm, Clinical Investigation","Inclusion Criteria:\n\n* Male\u002FFemale ≥ 18 years\n* Ability to understand the proposed treatment and express an informed acceptance by signing the informed consent\n* Diagnosis of primary and\u002For secondary visceral localizations of any histotype\n* Patients who are not eligible for standard curative procedures\n\nExclusion Criteria:\n\n* Absolute contraindications to invasive procedures\n* Concomitant presence of brain, lung, bone metastases\n* Uncorrectable coagulation changes\n* Bleomycin allergy\n* Absolute contraindications to taking Bleomycin\n* Poor respiratory function or pulmonary fibrosis\n* Acute lung infections\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study","ALL","18 Years","99 Years",{"count":60,"type":61},24,"ESTIMATED","INTERVENTIONAL",[64],"NA","This is an monocenter, single arm, clinical investigation that evaluate the impact of the method on the objective response rate (ORR) of visceral lesions undergoing electrochemotherapy. Electrochemotherapy is a well-defined method for the treatment of cutaneous and subcutaneous metastases of different tumor histotypes.\n\nAlthough still limited, the various experiences in the treatment of visceral localizations, particularly in liver metastases from colorectal cancer are promising and show that electrochemotherapy is a safe treatment, even in the case of lesions near large vessels or nerves. The investigators therefore propose a clinical investigation with a Medical Device according to EU Regulation 745\u002F2017, using electrochemotherapy (Cliniporator) with bleomycin for the treatment of visceral, primary or secondary, unresectable localizations, with percutaneous or intraoperative technique (laparoscopic or laparotomy), as needed.",[67,68,69,70,71,72,73,74,75,76,77,78],"Primary Visceral Tumors of Any Histotype","Visceral Lesions","Liver Cancer","Liver Metastasis Colon Cancer","Melanoma","Primary Pancreatic Tumor","Retroperitoneal Sarcoma","Abdominal and\u002For Peritoneal Localizations","Merkel Cell Carcinoma","Squamous Cell Carcinoma","Secondary Visceral Localizations of Any Histotype","Non-melanoma Skin Cancer",[9,80,81,82,83,84,85],"visceral lesions","Laparoscopic procedure","Laparotomic procedure","Percutaneous procedure","bleomycin","medical device","2026-04-09",{"date":88,"type":89},"2026-04-13","ACTUAL",{"date":91,"type":89},"2025-07-23",{"date":93,"type":61},"2030-02-28",{"name":5,"class":6},1]