[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540121":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":127,"collaborators":20,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":20,"enrollmentInfo":138,"targetDuration":20,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":20,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Urotronic Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Arm","OTHER","Optilume BPH Catheter System",[13],"Device: Optilume® BPH Catheter System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Optilume® BPH Catheter System","The Optilume BPH Catheter System is a combination drug\u002Fdevice minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Steven Kaplan, MD, FACS","Professor of Urology","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Jill Moland","CONTACT","612-245-6434","jmoland@laborie.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Brandon Shuler","701-220-1710","bshuler@laborie.com",[37,58,75,92,110],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Arkansas Urology","RECRUITING","Little Rock","Arkansas","72211","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-92.28959,34.74648,{"lat":49,"lon":48},[52,56],{"name":53,"role":29,"phone":54,"phoneExt":20,"email":55},"Katie O'Brien","501-830-8050","katie@arkansasurology.com",{"name":57,"role":25,"phone":20,"phoneExt":20,"email":20},"Jeffrey Marotte, MD",{"facility":59,"status":39,"city":60,"state":61,"zip":62,"country":43,"countryCode":44,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Florida Urology Partners, LLP","Tampa","Florida","33615",{"type":46,"coordinates":64},[65,66],-82.45843,27.94752,{"lat":66,"lon":65},[69,73],{"name":70,"role":29,"phone":71,"phoneExt":20,"email":72},"Linda Seibert","239-223-4488","linda@gulfcoastcta.com",{"name":74,"role":25,"phone":20,"phoneExt":20,"email":20},"Osvaldo Padron, MD",{"facility":76,"status":39,"city":77,"state":78,"zip":79,"country":43,"countryCode":44,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Ochsner LSU Health Shreveport - Regional Urology","Shreveport","Louisiana","71106",{"type":46,"coordinates":81},[82,83],-93.75018,32.52515,{"lat":83,"lon":82},[86,90],{"name":87,"role":29,"phone":88,"phoneExt":20,"email":89},"Kayla Telano","318-383-4319","kayla.telano@ochsnerlsuhs.org",{"name":91,"role":25,"phone":20,"phoneExt":20,"email":20},"Jared Moss, MD",{"facility":93,"status":39,"city":94,"state":95,"zip":96,"country":43,"countryCode":44,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Sheldon Freedman MD, Ltd","Las Vegas","Nevada","89144",{"type":46,"coordinates":98},[99,100],-115.13722,36.17497,{"lat":100,"lon":99},[103,108],{"name":104,"role":29,"phone":105,"phoneExt":106,"email":107},"Danielle Freedman","702-732-0282","232","drfreedman@msn.com",{"name":109,"role":25,"phone":20,"phoneExt":20,"email":20},"Sheldon Freedman, MD",{"facility":111,"status":39,"city":112,"state":113,"zip":114,"country":43,"countryCode":44,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Midtown Urology Associates","Austin","Texas","78705",{"type":46,"coordinates":116},[117,118],-97.74306,30.26715,{"lat":118,"lon":117},[121,125],{"name":122,"role":29,"phone":123,"phoneExt":20,"email":124},"Andrew Barger, APRN","512-451-7935","APBarger@cimplify.net",{"name":126,"role":25,"phone":20,"phoneExt":20,"email":20},"Michael Trotter, MD",{"type":128,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100540121","safety-and-effectiveness-of-the-optilume-bph-catheter-system-in-a-post-market-study-100540121",false,"NCT06312722","Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study","PEAK","Inclusion Criteria:\n\n1. Male subject ≥ 50 years old\n2. Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)\n3. Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use\n4. Prostate volume \\\u003C 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)\n5. International Prostate Symptom Score (IPSS) ≥ 13\n6. Peak urinary flow rate (Qmax) 5-15 mL\u002Fsec with minimum voided volume of 125 mL\n7. Willing to provide informed consent and comply with protocol required follow-up\n\nExclusion Criteria:\n\n1. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure\n2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate\n3. Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate\n4. Confirmed or suspected malignancy of prostate or bladder. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is \\> 4 ng\u002FmL with free PSA \\\u003C 25%.\n5. Active urinary tract infection (UTI) confirmed by culture\n6. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function\n7. History of overt urinary incontinence requiring the use of pads\n8. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms\n9. Current post-void residual volume (PVR) \\> 300 mL or catheter dependent bladder drainage\n10. Known poor detrusor muscle function (e.g., Qmax \\\u003C 5 mL\u002Fsec)\n11. Active bladder, ureteral, or urethral stones or stone passage within the last 3 months\n12. Current poorly controlled diabetes (i.e., hemoglobin A1c ≥ 8%)\n13. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System\n14. Obstructive median lobe in the opinion of the investigator","MALE","50 Years",{"count":139,"type":140},92,"ESTIMATED","INTERVENTIONAL",[143],"NA","The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.",[146],"Benign Prostatic Hyperplasia","2026-01-12",{"date":149,"type":150},"2026-01-14","ACTUAL",{"date":152,"type":150},"2024-02-07",{"date":154,"type":140},"2031-02-07",{"name":5,"class":6},5]