[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594421":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with low-grade NMIBC","EXPERIMENTAL",null,[13],"Drug: Gemcitabine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Gemcitabine","Intravesical installation",[9],[21],{"name":22,"affiliation":23,"role":24},"Shahrokh F. Shariat Prof. Dr., Professor","Department of Urology, Medical University of Viernna","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Ekaterina Laukhtina Dr., Medical Doctor","CONTACT","+43 (0)1 40400-26315","ekaterina.laukhtina@meduniwien.ac.at",[32],{"facility":33,"status":34,"city":35,"state":11,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Department of Urology, Medical University of Vienna","RECRUITING","Vienna","1090","Austria","AT",{"type":40,"coordinates":41},"Point",[42,43],16.37208,48.20849,{"lat":43,"lon":42},[46],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Ekaterina Laukhtina","Dr.","100594421","phase-2-chemoablation-for-low-grade-bladder-cancer-100594421",false,"NCT07019220","Chemoablation for Low-Grade Bladder Cancer","COBRA - Chemoablation for Low Grade Bladder Cancer: A Single Arm, Prospective, Open-label, Investigator-initiated Phase 2 Study","COBRA","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study\n* Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening\n* On screening cystoscopy: Diameter of the largest lesion ≤15mm\n* Number of lesions ≤5\n* Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation\n* Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk)\n* NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT)\n* Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening\n* No lymph node metastasis or distant metastasis\n* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment\n* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Female patients of childbearing potential must use adequate contraception during study period\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Tumors that clinicians suspect to be HG\n* Positive HG cytology according to Paris criteria\n* Diameter of tumor \\>15 mm\n* Number of lesions \\>5\n* Any previous intravesical therapy within 1 year\n* Previous HG NMIBC (within the last 3 years). It is allowed to include patients who had history of HG disease longer than 3 years ago.\n* Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC\n* History of upper tract urothelial carcinoma (UTUC)\n* Clinically significant urethral stricture that would preclude passage of a urethral catheter\n* History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding\n* Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and\u002For administration of study treatment\n* Patient refused to participate\n* Known positive human immunodeficiency virus (HIV) test.\n* Female patients who are pregnant\u002Fbreastfeeding.\n* Female patients of childbearing potential not using adequate contraception.","ALL","18 Years",{"count":62,"type":63},47,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.",[69],"Bladder (Urothelial, Transitional Cell) Cancer",[71,72,73],"Non-Muscle Invasive Bladder Cancer","Intravesical Therapy","Non-Surgical Treatment","2025-06-12",{"date":76,"type":77},"2025-06-13","ACTUAL",{"date":79,"type":77},"2023-12-27",{"date":81,"type":63},"2027-11",{"name":49,"class":6},1]