[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613900":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":19,"responsibleParty":30,"collaborators":19,"id":33,"slug":19,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":19,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":19,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":56,"whyStopped":19,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":19},{"fullName":5,"class":6},"Qilu Hospital of Shandong University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Plasma-Activated Saline Solution (PASS) Bladder Instillation","EXPERIMENTAL","This arm involves the intravesical instillation of the experimental intervention, Plasma-Activated Saline Solution (PASS), where 200 mL of the solution is administered into the bladder via a catheter every other day for 7 days, with a 1-hour dwell time, to evaluate its local efficacy in inducing tumor cell death and assess safety and tolerability.",[13],"Drug: Plasma-Activated Saline Solution (PASS) Bladder Instillation",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","This intervention is distinguished by its unique mechanism of action, which utilizes physically-activated normal saline infused with reactive oxygen and nitrogen species (RONS) generated by non-thermal plasma, creating a potent yet transient cytotoxic solution that is administered locally.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"benkang shi","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"weiqiang jing, PhD","CONTACT","86+053182166714","jiangxin98@sdu.edu.cn",{"type":23,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Benkang Shi","Head of Urology Department","100613900",false,"NCT07272603","Bladder Perfusion of Plasma-Activated Saline for Bladder Cancer","Preliminary Clinical Study Evaluating the Therapeutic Response and Safety of Intravesical Perfusion With Plasma-Activated Saline Solution in Patients With Bladder Cancer","Inclusion Criteria:\n\n1. Patients with a pathological diagnosis of bladder cancer.\n2. Patients scheduled for radical cystectomy, with at least one measurable tumor lesion ≥10 mm in diameter.\n3. Age between 18 and 75 years.\n4. Treatment-naïve patients who have not received any prior therapy for bladder cancer.\n\nExclusion Criteria:\n\n1. Presence of severe comorbidities, including but not limited to cardiac disease, severe hepatic or renal insufficiency, uncontrolled hypertension, or diabetes.\n2. Active urinary tract infection or a functional bladder capacity of less than 200 mL.\n3. History of other malignancies.\n4. Pregnancy or lactation.\n5. Poor compliance, assessed as unlikely to complete the trial per protocol requirements.\n6. Any other condition deemed by the investigator to make the patient unsuitable for study participation.","ALL","18 Years","75 Years",{"count":43,"type":44},5,"ESTIMATED","INTERVENTIONAL",[47],"EARLY_PHASE1","This preliminary clinical study evaluates the safety and initial efficacy of a novel therapy called Plasma-Activated Saline Solution (PASS) for bladder cancer patients. The study involves a one-week course of PASS administered via bladder infusion in five pre-surgical patients, using imaging and pathology analyses to assess tumor shrinkage and cancer cell death, while closely monitoring for any adverse reactions to explore the therapy's future potential.",[50],"Bladder (Urothelial, Transitional Cell) Cancer",[52,53,54,55],"bladder","cancer","Intravesical Perfusion","plasma","NOT_YET_RECRUITING","2025-11-26",{"date":59,"type":60},"2025-12-09","ACTUAL",{"date":62,"type":44},"2025-12-15",{"date":64,"type":44},"2026-02-15",{"name":5,"class":6}]