[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vivifi Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100650139","vivifi-device-safety-evaluation-for-the-treatment-of-benign-prostatic-hyperplasia-100650139",false,"NCT07745621","Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia","Safety and Efficacy Evaluation of the Vivifi Device for Treatment of Symptomatic Benign Prostatic Hyperplasia","BPH","Inclusion Criteria:\n\n1. Male 45-80 years of age\n2. Diagnosed with Benign prostatic hyperplasia (BPH)\n3. Prostate volume: ≥ 40 ≤ 100 cc measured by MRI\n4. Qmax ≤ 10 mL\u002Fs on two measures (voided volume ≥ 125 mL)\n5. Assessment of future paternity plans\n6. Signed the study informed consent\n7. Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12\n\nExclusion Criteria:\n\n1. Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy.\n2. Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable\n3. Intravesical prostatic protrusion (IPP) \\> 10 mm\n4. Post-void residual volume (PVR) \\> 200ml\n5. IPSS QoL score ≤ 3\n6. Prostate cancer diagnosis, suspicious DRE, or PSA \\> 10ng\u002FmL\n7. Patients with clinical history of chronic prostatitis.\n8. Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days), or urethral strictures.\n9. Major neurological conditions such as Alzheimer's, Parkinsons, Multiple sclerosis, ALS, spinal cord injury\n10. Patients who are unable to undergo the required anesthesia for the procedure\n11. Patients on testosterone replacement therapy\n12. Patients unable to hold blood thinners, or with coagulation related issues\n13. Patients currently taking medication for BPH (eg. Alpha-blockers or 5-ARIs) who are unwilling or unable to discontinue (washout) prior to treatment (14 days for α-blockers (tamsulosin, alfuzosin, silodosin, doxazosin, terazosin), 8 weeks for finasteride, 5 months for dutasteride)\n14. Diagnosis of Hidradenitis suppurativa","MALE","45 Years","80 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"NA","The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).",[28],"Benign Prostatic Hyperplasia",[15],"NOT_YET_RECRUITING","2026-07-29",{"date":33,"type":34},"2026-08-04","ACTUAL",{"date":36,"type":22},"2026-09",{"date":38,"type":22},"2028-12",{"name":40,"class":41},"Vivifi Medical","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":42},"100548739","vivifis-treatment-bph-treatment-via-vasculature-anastomosis-100548739","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","40 Years","75 Years",{"count":21,"type":22},[25],"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.",[28,56,57],"Varicocele Grade II","Varicocele Grade III",[15,59],"Varicocele","RECRUITING","2025-04-08",{"date":63,"type":34},"2025-04-11",{"date":65,"type":34},"2024-11-13",{"date":67,"type":22},"2026-06-30",{"name":40,"class":41},""]