[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"enlarged-prostate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:enlarged-prostate":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"100654284","phase-4-prospective-post-market-clinical-trial-for-the-zenflow-spring-system---a-minimally-invasive-treatment-for-luts-associated-with-bph-100654284",false,"NCT07797348","Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH.","Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH","Inclusion Criteria:\n\nThe Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.\n\nIn addition to the above labeling requirements, patients must also meet all the following criteria to be eligible for enrollment in this study:\n\n1. Moderate to severe LUTS, defined as an International Prostate Symptom Score (IPSS ≥ 8)\n2. Not actively taking any medication indicated for BPH, defined as current use of:\n\n   1. Alpha-adrenergic antagonists (Alpha Blockers) within 2 weeks of baseline IPSS assessment\n   2. 5-alpha reductase inhibitors (5ARI) within 6 months of baseline IPSS assessment\n   3. PDE5 daily use (on demand use is permitted)\n3. Ability to provide informed consent and comply with study procedures and follow-up schedule\n\nExclusion Criteria:\n\n1. Known, previous adverse reaction to use of alpha-adrenergic antagonists (e.g., Tamsulosin)\n2. Neurologic conditions affecting bladder function, including but not limited to:\n\n   1. Multiple sclerosis\n   2. Parkinson's disease\n   3. Neurogenic bladder or other conditions causing non-obstructive voiding dysfunction","MALE","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This is a prospective, randomized, open-label, parallel-group post-market clinical trial (PMCT). The overall objective of this PMCT is to compare the effectiveness, durability, and patient-centered outcomes of the Zenflow Spring System versus Tamsulosin in men who are not on active therapy with moderate to severe LUTS\u002FBPH. Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria.",[26,27,28],"Benign Prostatic Hyperplasia (BPH)","Obstructive Lower Urinary Tract Symptoms (LUTS)","Enlarged Prostate",[30,31,32,33,34,35,36,37,38,39],"obstructive lower urinary tract symptoms (LUTS), Benign Prostatic Hyperplasia (BPH),","enlarged prostate","BPH","LUTS","urinary tract symptoms","Benign Prostatic Hyperplasia","obstructive lower urinary tract symptoms","minimally invasive","relieve prostatic urethral obstruction","early intervention","NOT_YET_RECRUITING","2026-08-27",{"date":43,"type":44},"2026-09-01","ACTUAL",{"date":43,"type":20},{"date":47,"type":20},"2029-09-01",{"name":49,"class":50},"Zenflow, Inc.","INDUSTRY"]