[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578933":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rezum","EXPERIMENTAL","Participants in this group will undergo transurethral thermal vaporization of the prostate.",[13],"Procedure: Transurethral Thermal Vaporization of the Prostate",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Transurethral Thermal Vaporization of the Prostate","After anesthesia, the patient is placed in the lithotomy position, and standard aseptic preparation and draping are performed. A cystoscope and a transrectal ultrasound (TRUS) probe are inserted. Following real-time image fusion and localization according to the preoperative plan, needles are inserted to deliver thermal vaporization to the prostate. Each needle treatment lasts 8 seconds, and the entire procedure is completed within 200 seconds after activation of the needle pathway.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Qing Yuan, Doctor of Medicine","CONTACT","8601018910980422","qyuanmd@outlook.com",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.39723,39.9075,{"lat":39,"lon":38},[42,45],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":26},"Qing Yuan","8618910980422",{"name":46,"role":24,"phone":20,"phoneExt":20,"email":26},"Yuan",{"type":48,"investigatorFullName":43,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Professor","100578933","clinical-study-on-prostate-thermal-vapor-ablation-guided-by-mritrus-fusion-imaging-100578933",false,"NCT06817733","Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI\u002FTRUS Fusion Imaging","Inclusion Criteria:\n\n* Age 45-85 years;\n* International Prostate Symptom Score (IPSS) ≥ 8, indicating moderate to severe Lower Urinary Tract Symptoms (LUTS) that significantly impact quality of life;\n* Poor response to pharmacological treatment or refusal of pharmacological treatment;\n* Prostate volume 30-80 mL;\n* Maximum urinary flow rate (Qmax) \\\u003C 15 mL\u002Fs;\n* Post-void residual urine volume (PVR) \\\u003C 300 mL;\n* Willingness to provide informed consent and participate in postoperative follow-up.\n\nExclusion Criteria:\n\n* Prostate volume \\\u003C 30 mL or \\> 80 mL;\n* Severe urinary tract infection;\n* Preoperative definitive diagnosis of prostate cancer;\n* Known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-BPH causes of urinary obstruction;\n* Patients with prostatitis;\n* History of invasive prostate interventions, such as radiofrequency ablation, laser therapy, or microwave treatment;\n* Patients with severe cardiovascular disease, chronic obstructive pulmonary disease, severe diabetes, hepatic or renal dysfunction, or systemic bleeding disorders, as assessed by the investigator to be unsuitable for surgery.","MALE","45 Years","85 Years",{"count":60,"type":61},30,"ESTIMATED","INTERVENTIONAL",[64],"NA","Objective of the Clinical Trial\n\nThe objective of this clinical trial is to preliminarily assess the feasibility and safety of performing precise prostate thermal vapor ablation under MRI\u002FTURS guidance. The primary questions it aims to address are:\n\nCan precise prostate thermal vapor ablation under MRI\u002FTURS guidance effectively treat benign prostatic hyperplasia (BPH) and alleviate lower urinary tract symptoms (LUTS)? What safety issues may arise in participants after undergoing prostate thermal vapor ablation? Study Procedures Participants Preoperative Evaluation: Participants will undergo comprehensive preoperative assessments, including clinical examinations and laboratory tests.\n\nProcedure: Participants will receive precise prostate thermal vapor ablation under MRI\u002FTURS guidance.\n\nPostoperative Follow-up:\n\nRegular follow-up to reassess prostate volume. Periodic completion of the International Prostate Symptom Score (IPSS) questionnaire.\n\nRegular measurement of maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR).\n\nResearch Team The research team will conduct precise prostate thermal vapor ablation under MRI\u002FTURS guidance for the participants and manage their follow-up assessments.",[67],"Benign Prostatic Hyperplasia (BPH)",[69,9,70],"Benign prostatic hyperplasia","MRI-TRUS","2025-12-04",{"date":73,"type":74},"2025-12-05","ACTUAL",{"date":76,"type":74},"2025-02-15",{"date":78,"type":61},"2025-12-31",{"name":5,"class":6},1]