[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567434":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":29,"locations":37,"responsibleParty":87,"collaborators":20,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":20,"eligibilityCriteria":94,"healthyVolunteers":91,"sex":95,"minAge":96,"maxAge":20,"enrollmentInfo":97,"targetDuration":20,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":40,"whyStopped":20,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Andromeda Surgical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"A single-arm open label pilot study","EXPERIMENTAL","A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.",[13],"Device: Beacon Platform",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Beacon Platform","The Beacon Platform is a robotically assisted surgical (RAS) device. It enables the urologist, through software, to control and move surgical instruments for a variety of transurethral, endoscopic procedures",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Peter Gilling, MD, FRACS","Tauranga urology research","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":25},"Rodrigo Ledezma, MD,","University of Chile Clinical Hospital",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":20,"email":34},"Rami Abukhalil, MD. MPH","CONTACT","513-808-2097","rami@andromedasurgical.com",{"name":36,"role":32,"phone":20,"phoneExt":20,"email":20},"Michael Nketiah",[38,60,72],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Universidad Catolica de Chile","RECRUITING","Santiago","Santiago Metropolitan","8320165","Chile","CL",{"type":47,"coordinates":48},"Point",[49,50],-70.64827,-33.45694,{"lat":50,"lon":49},[53,57,59],{"name":54,"role":32,"phone":55,"phoneExt":20,"email":56},"Cristian Trucco Brito","+56992341965","ctrucco@ucchristus.cl",{"name":58,"role":32,"phone":20,"phoneExt":20,"email":20},"Gaston Astroza",{"name":54,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":61,"status":40,"city":41,"state":42,"zip":62,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Hospital Clínico de la Universidad de Chile","8380453",{"type":47,"coordinates":64},[49,50],{"lat":50,"lon":49},[67,71],{"name":68,"role":32,"phone":69,"phoneExt":20,"email":70},"Rodrigo Ledezma","+56977593793","rodrigoledezma@gmail.com",{"name":68,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":73,"status":40,"city":74,"state":20,"zip":20,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Tauranga Urology Research Limited","Tauranga","New Zealand","NZ",{"type":47,"coordinates":78},[79,80],176.16667,-37.68611,{"lat":80,"lon":79},[83],{"name":84,"role":32,"phone":85,"phoneExt":20,"email":86},"Margaret Ross","64 (7) 577 77 95","marg@urobop.co.nz",{"type":88,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100567434","a-prospective-multicenter-open-label-study-of-the-beacon-platform-for-holmium-laser-enucleation-of-the-prostate-holep-100567434",false,"NCT06668142","A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)","Inclusion Criteria:\n\n1. Male\n2. Subject has diagnosis of lower urinary tract symptoms and\u002For urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,\n3. Subject is able and willing to comply with all the assessments of the study,\n4. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the informed consent form,\n5. ≥ 45 years of Age,\n6. Prostate volume 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year prior to procedure,\n7. The subject is indicated for undergoing HoLEP procedure\n\nExclusion Criteria:\n\n1. Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,\n2. History of prostate cancer or current\u002Fsuspected bladder cancer,\n3. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,\n4. History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),\n5. Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,\n6. Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated)\n7. Previous pelvic irradiation or radical pelvic surgery,\n8. Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift,\n9. Inability to stop taking anticoagulants for at least 3 days prior to the procedure or antiplatelets and\u002For coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy is permitted),\n10. Any severe illness that would prevent complete study participation or confound study results.\n11. Bleeding tendency disorders,\n12. Future fertility concerns,\n13. Subject has any other disease or condition(s) that would interfere with completion of the study and follow-up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes,\n14. Concomitant participation in another interventional study","MALE","45 Years",{"count":98,"type":99},54,"ESTIMATED","INTERVENTIONAL",[102],"NA","Robotic assisted surgery for benign prostatic hyperplasia (BPH)",[105],"Benign Prostatic Hyperplasia",[107,108,109,110,111,112,113,114,115],"HoLEP","RoLEP","Robotic HoLEP","BPH","Prostate","urology","robotic","Andromeda","ASTRA","2026-03-19",{"date":118,"type":119},"2026-03-23","ACTUAL",{"date":121,"type":119},"2024-12-12",{"date":123,"type":99},"2026-12-30",{"name":5,"class":6},3]