[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548739":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":20,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Vivifi Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","Subjects undergo Vivifi's surgical procedure for treatment of BPH.",[13],"Procedure: Vivifi's Surgical Procedure",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Vivifi's Surgical Procedure","Subjects undergo Vivifi's surgical procedure for treatment of BPH. The study procedure will be performed in the operating room, under general anesthesia.\n\nSubject will undergo a bilateral anastomosis of the internal spermatic vein to the inferior epigastric vein and ligation of the deferential vein via bilateral inguinal\u002Fsubinguinal incision.\n\nThe investigators can use of a coupler with appropriate ring size (to be measured intra-operatively based on vessel size) to perform the vascular anastomosis and standard sutures for ligation. The coupler is an FDA approved commercial device. Alternatively, the anastomosis can also be performed using sutures. Incision closure will proceed per institution standard of care.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Nathan Starke, MD","Vivifi Medical (Chief Medical Officer)","STUDY_CHAIR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Yunlong Zhang, Master of Science","CONTACT","669-203-9308","pzhang@rqmplus.com",{"name":33,"role":29,"phone":20,"phoneExt":20,"email":34},"Tushar Sharma, CEO of Vivifi (Study sponsor)","tushar@vivifimedical.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":20,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hospital Paitilla","RECRUITING","Panama City","Provincia de Panamá","Panama","PA",{"type":44,"coordinates":45},"Point",[46,47],-79.51973,8.9936,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":52,"phoneExt":20,"email":53},"Natalia Vega, Director","(011) 507-6499-9304","nvega@candmresearch.org",{"type":55,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[57],{"name":58,"class":6},"RQM+","100548739","vivifis-treatment-bph-treatment-via-vasculature-anastomosis-100548739",false,"NCT06424912","Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis","Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis of the Internal Spermatic Vein and Ligation of the Deferential Vein","Inclusion Criteria:\n\n1. Male 40-75 years of age\n2. Diagnosed with Benign prostatic hyperplasia (BPH)\n3. Prostate volume: ≥ 30 ≤ 120 cc measured by transrectal ultrasound\n4. Signed the study informed consent form (ICF)\n5. Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12\n6. Presence of clinical varicocele (preferably grade II or III - Dubin \\& Amelar.\n\nExclusion Criteria:\n\n1. Patients with prior history of spermatic vein or pampiniform plexus related surgeries or impairment, or vasectomy\n2. Previous invasive prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.)\n3. Prostate with large intravesical median lobe\n4. Patients with sub-clinical varicocele\n5. Post-void residual volume (PVR) \\> 110ml\n6. IPSS (International Prostate Symptoms Score) \\>24\n7. Patients with clinical history of chronic prostatitis.\n8. Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days).\n9. Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury\n10. Patients that can not be under general anesthesia\n11. Patients on blood thinners, or with coagulation related issues, TTP\n12. Prior pelvic floor surgery or condition such as inguinal hernia, mesh, etc\n13. History of cancer in genitourinary system, which is not considered being cured. A potential participant is considered cured if there has been no evidence of cancer within five years of the study.\n14. Inability to provide legally effective Informed Consent Form (ICF) and\u002For comply with all of the required follow-up requirements\n15. Subject currently participating in other investigational studies unless approved by the Sponsor in writing","MALE","40 Years","75 Years",{"count":70,"type":71},20,"ESTIMATED","INTERVENTIONAL",[74],"NA","The study objective is to evaluate the safety and feasibility of the Vivifi's Treatment.\n\nThe Vivifi's Treatment presents an innovative approach for addressing benign prostatic hyperplasia (BPH) as well as clinical\u002Fsubclinical varicoceles in men. The scientific rationale for conducting this study is to assess the safety and feasibility of the Vivifi's Treatment (a surgical procedure) as a therapeutic intervention for patients with BPH.",[77,78,79],"Benign Prostatic Hyperplasia","Varicocele Grade II","Varicocele Grade III",[81,82],"BPH","Varicocele","2025-04-08",{"date":85,"type":86},"2025-04-11","ACTUAL",{"date":88,"type":86},"2024-11-13",{"date":90,"type":71},"2026-06-30",{"name":5,"class":6},1]