[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650139":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":32,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":18,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":72,"whyStopped":18,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Vivifi Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Minimally invasive percutaneous ablation","EXPERIMENTAL","Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach",[13],"Device: Minimally invasive percutaneous ablation",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DEVICE",[9],null,[20],{"name":21,"affiliation":18,"role":22},"Daniel Root, MD","STUDY_CHAIR",[24,28],{"name":21,"role":25,"phone":26,"phoneExt":18,"email":27},"CONTACT","503-757-5281","dan@vivifimedical.com",{"name":29,"role":25,"phone":30,"phoneExt":18,"email":31},"Susan Brief, MS","612-309-1320","sue.brief@clinical-research-pro.com",[33],{"facility":34,"status":18,"city":35,"state":36,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":18},"Hospital Paitilla","Panama City","Provincia de Panamá","Panama","PA",{"type":40,"coordinates":41},"Point",[42,43],-79.51973,8.9936,{"lat":43,"lon":42},{"type":46,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[48],{"name":49,"class":50},"RQM Plus","UNKNOWN","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":63,"type":64},20,"ESTIMATED","INTERVENTIONAL",[67],"NA","The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).",[70],"Benign Prostatic Hyperplasia",[57],"NOT_YET_RECRUITING","2026-07-29",{"date":75,"type":76},"2026-08-04","ACTUAL",{"date":78,"type":64},"2026-09",{"date":80,"type":64},"2028-12",{"name":5,"class":6},1]