[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650139":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":51,"studyPopulation":47,"armGroups":52,"interventions":59,"overallOfficials":63,"centralContacts":67,"locations":76,"responsibleParty":89,"collaborators":91,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":47,"studyType":109,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":115,"whyStopped":47,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Vivifi Medical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":31},[9,13],{"measure":10,"description":11,"timeFrame":12},"Primary Safety Endpoint","Number of participants experiencing device or procedure related adverse events assessed by severity and causality.","24 month follow-up",{"measure":14,"description":15,"timeFrame":16},"Mean change from baseline International Prostate Symptom Score (IPSS) at 24 months","The IPSS is a validated 7-item questionnaire scored 0-25: higher scores indicate worse urinary symptoms. Mean change from baseline will be reported.","From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.",[18,21,24,27],{"measure":19,"description":20,"timeFrame":16},"Mean change from baseline in ejaculatory function assessed by Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)","The Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) is a validated, 4 item, patient-reported outcome instrument that assesses ejaculatory function and bother in men, evaluating domains of ejaculation force, volume, frequency, and satisfaction. A higher score on the first 3 domains indicates better ejaculatory function and the final domain indicates higher quality of life.",{"measure":22,"description":23,"timeFrame":16},"Mean change from baseline in prostate volume (cc) measured by MRI","Mean change from baseline in prostate volume (cubic centimeters) as measured by magnetic resonance imaging (MRI) at specified follow-up time points. A reduction in prostate volume is desirable.",{"measure":25,"description":26,"timeFrame":16},"Mean change from baseline in peak urinary flow rate (Qmax, mL\u002Fs) measured by uroflow","Mean change from baseline in peak urinary flow rate (Qmax, milliliters per second) as measured by uroflowmetry at specified follow-up time points.",{"measure":28,"description":29,"timeFrame":30},"Mean change from baseline in post-void residual volume (PVR, mL) measured by ultrasound or bladder scan","Mean change from baseline in post-void residual urine volume (PVR, milliliters) as measured by ultrasound or bladder scan at specified follow-up time points.","Baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.",[32,36,40],{"measure":33,"description":34,"timeFrame":35},"Procedure Duration","Time of procedure in minutes","Day of procedure",{"measure":37,"description":38,"timeFrame":39},"Change from baseline in serum PSA (ng\u002Fdl) and testosterone (ng\u002Fdl)","Mean change from baseline in serum prostate-specific antigen (PSA, nanograms per milliliter) and total testosterone (nanograms per deciliter) as measured by standard laboratory assay at specified follow-up time points.","Baseline, 1 month, 3 months, 6 months, 12 months, 24 months",{"measure":41,"description":42,"timeFrame":43},"Cystoscopic assessment of urethral and bladder integrity","Cystoscopic evaluation of urethral and bladder mucosal integrity at specified follow-up time points to assess for procedure-related anatomical changes or adverse findings.","From baseline, 1 month, 3 months, 6 months, 12 months",{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":47,"timePerspective":47,"maskingInfo":49},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":50,"maskingDescription":47,"whoMasked":47},"NONE","The Vivifi Device and procedure will be an alternative treatment for symptomatic BPH. Where other currently available treatments are generally either procedures that destroy and\u002For remove prostatic tissue or that involve a minimally-invasive surgical therapy, the Vivifi device is a less invasive percutaneous approach that does not require urethral entry, tissue removal, or implants. By addressing a contributing root cause of prostatic growth through a minimally invasive percutaneous approach, unwanted enlargement of the prostate may be halted or reversed, without damage to the prostatic tissue or urethra.These initial clinical studies will test the safety and feasibility of this approach.",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"Minimally invasive percutaneous ablation","EXPERIMENTAL","Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach",[58],"Device: Minimally invasive percutaneous ablation",[60],{"type":61,"name":54,"description":56,"armGroupLabels":62,"otherNames":47},"DEVICE",[54],[64],{"name":65,"affiliation":47,"role":66},"Daniel Root, MD","STUDY_CHAIR",[68,72],{"name":65,"role":69,"phone":70,"phoneExt":47,"email":71},"CONTACT","503-757-5281","dan@vivifimedical.com",{"name":73,"role":69,"phone":74,"phoneExt":47,"email":75},"Susan Brief, MS","612-309-1320","sue.brief@clinical-research-pro.com",[77],{"facility":78,"status":47,"city":79,"state":80,"zip":47,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":47},"Hospital Paitilla","Panama City","Provincia de Panamá","Panama","PA",{"type":84,"coordinates":85},"Point",[86,87],-79.51973,8.9936,{"lat":87,"lon":86},{"type":90,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[92],{"name":93,"class":94},"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":107,"type":108},20,"ESTIMATED","INTERVENTIONAL",[45],"The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).",[113],"Benign Prostatic Hyperplasia",[101],"NOT_YET_RECRUITING","2026-07-29",{"date":118,"type":119},"2026-08-04","ACTUAL",{"date":121,"type":108},"2026-09",{"date":123,"type":108},"2028-12",{"name":5,"class":6},1]