[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Urotronic Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,71,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100468706","phase-4-optilume-post-approval-clinical-evaluation-of-andrology-parameters-100468706",false,"NCT05383274","Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters","STREAM","Inclusion Criteria:\n\n1. Male subjects between 22 and 65 years of age\n2. Subject diagnosed with a stricture in the anterior urethra that is able to be treated with the Optilume Urethral DCB in accordance with the approved Instructions for Use\n3. Subject is willing to provide written informed consent and comply with study required follow-up assessments\n4. Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):\n\n   1. total sperm ≥39 million\n   2. sperm concentration ≥15 million\u002FmL\n   3. total motility ≥40%\n   4. progressive motility ≥32%\n   5. morphology ≥4%\n\nExclusion Criteria:\n\n1. Subjects with a known hypersensitivity to paclitaxel or structurally related compounds\n2. Subjects with a history of vasectomy or other condition that may inhibit semen\u002Fsperm production or ejaculatory function\n3. Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout\n4. Subject is unwilling to abstain or utilize a condom for 30 days after the procedure\n5. Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential\n6. History of cancer in any body system that is not considered in complete remission","MALE","22 Years","65 Years",{"count":20,"type":21},34,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.",[27],"Urethral Stricture","RECRUITING","2026-04-27",{"date":31,"type":32},"2026-04-28","ACTUAL",{"date":34,"type":32},"2022-02-14",{"date":36,"type":21},"2026-12-30",{"name":38,"class":39},"Urotronic Inc.","INDUSTRY",9,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":40},"100559157","optilume-bph-catheter-system-for-treatment-of-men-experiencing-symptomatic-bph-100559157","NCT06560476","OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH","A Prospective Multi-site Registry of Real-world Experience With the OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH","APEX","Inclusion Criteria:\n\n1\\. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).\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. Confirmed or suspected malignancy of prostate or bladder.\n4. Active urinary tract infection (UTI)\n5. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System",{"count":50,"type":21},500,"2 Years","OBSERVATIONAL","APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.",[55],"Benign Prostatic Hyperplasia",[57,58,59,60,61,62],"BPH","Drug Coated Balloon","DCB","Prostate","LUTS","Optilume","2026-03-23",{"date":65,"type":32},"2026-03-27",{"date":67,"type":32},"2024-03-30",{"date":69,"type":21},"2027-03-30",{"name":38,"class":39},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":78,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100594520","evaluation-of-optilume-drug-coated-balloon-for-the-endoscopic-treatment-of-ureteric-strictures-100594520","NCT07020520","EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures","ENDURE1","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Single lesion ureteric or uretero-enteric stricture less than or equal to 4.0 cm in length\n3. Two functioning kidneys\n\nExclusion Criteria:\n\n1. Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment\n2. Subjects with more than one ureteric stricture\n3. Subjects with target stricture in bifid or duplicated ureter\n4. Known sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel\n5. Ureteric stricture caused by extrinsic compression of the ureter\n6. Unable to endoscopically access target stricture for any reason\n7. Existing stones in the ipsilateral kidney or ureter (except for asymptomatic kidney stones) that are in close proximity to the target ureteric stricture\n8. Chronic renal failure treated with dialysis\n9. eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2\n10. Kidney function ≤ 25% of split function on the side with target stricture as measured by functional renogram\n11. Kidney function ≤35% of split function on the side opposite target stricture as measured by functional renogram or other significant pathology or impairment that may impact renal function\n12. Life expectancy less than 12 months\n13. Women who are pregnant or breastfeeding\n14. Women of child-bearing potential planning to get pregnant in the next year or are unwilling to use contraception over the next 12 months\n15. Males unwilling to abstain or use protected sex for 30 days post treatment\n16. Males unwilling to use highly effective contraception for6 months post treatment if sexual partner(s) are of child-bearing potential\n17. Inability to provide legally effective informed consent\n18. Unwilling or unable to meet protocol follow-up requirements\n19. Participation in any interventional clinical investigation of a medical device, drug, or biologic (excluding registries) that may confound the results of the trial\n20. Active systemic or urinary tract infection\n21. Active malignancy in the abdomen or pelvis, or any malignancy considered considerable risk for metastasizing to the abdomen or pelvis over the next 12 months\n22. Uncontrolled diabetes defined as hemoglobin A1C ≥ 8% at baseline\n23. Unable to come off antiplatelet or anticoagulation medication prior to treatment to prevent bleeding complications at the discretion of the investigator\n24. Any other condition that may confound the results of the trial or presents an unacceptable risk for any study-related procedure\n25. Individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response\n26. Presence of any condition that precludes administration of furosemide during renograms\n27. Unable to tolerate contrast related to required study procedures or imaging.\n\nAdditional Criteria for Pharmacokinetic Substudy Inclusion Ureteric stricture measurements appropriate for treatment with a 6mm (18F) or 8mm (24F) diameter Optilume DCB Exclusion Prior treatment with any device or medical therapy that contains paclitaxel, including drug coated balloons for vascular and urethral applications","ALL","18 Years",{"count":81,"type":21},60,[83],"NA","The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.",[86],"Ureteral Stricture",[88,89,90,91,92],"ureteral","ureteric","stricture","stenosis","optilume","2026-03-06",{"date":95,"type":32},"2026-03-09",{"date":97,"type":32},"2025-10-01",{"date":99,"type":21},"2031-07-30",{"name":38,"class":39},7,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100540121","safety-and-effectiveness-of-the-optilume-bph-catheter-system-in-a-post-market-study-100540121","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","50 Years",{"count":111,"type":21},92,[83],"The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.",[55],"2026-01-12",{"date":117,"type":32},"2026-01-14",{"date":119,"type":32},"2024-02-07",{"date":121,"type":21},"2031-02-07",{"name":38,"class":39},5,""]