[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559562":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":101,"collaborators":65,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":65,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":65,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":125,"overallStatus":48,"whyStopped":65,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Fundacio Puigvert","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Endoscopic Prostate Enucleation Using Moses 2.0 Technology","ACTIVE_COMPARATOR","Pulse modulation technology in Moses 2.0 applied to Holmium Laser Endoscopic Prostate (MoLEP).",[13],"Procedure: MoLEP",{"label":15,"type":10,"description":16,"interventionNames":17},"Endoscopic Prostate Enucleation Using the New Thulium Fiber Laser","Thulium Fiber laser to endoscopic prostate enucleation (ThuFLEP).",[18],"Procedure: ThuFLEP",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","MoLEP","Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.",[9],[26],"Moses 2.0 Technology",{"type":21,"name":28,"description":23,"armGroupLabels":29,"otherNames":30},"ThuFLEP",[15],[31],"New Thulium Fiber Laser",[33],{"name":34,"affiliation":5,"role":35},"Ivan Schwartzmann Jochamowitz, MD","PRINCIPAL_INVESTIGATOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","0034934169700","4608","ischwartzm@fundacio-puigvert.es",{"name":43,"role":38,"phone":39,"phoneExt":44,"email":45},"Silvia Mateu, MD","4602","smateu@fundacio-puigvert.es",[47,69,84],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Barcelona","BARCELONA","08025","Spain","ES",{"type":55,"coordinates":56},"Point",[57,58],2.15899,41.38879,{"lat":58,"lon":57},[61,62,64,66],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},{"name":43,"role":38,"phone":63,"phoneExt":44,"email":45},"934169700",{"name":34,"role":35,"phone":65,"phoneExt":65,"email":65},null,{"name":67,"role":68,"phone":65,"phoneExt":65,"email":65},"Javier Ponce de León Roca, MD","SUB_INVESTIGATOR",{"facility":70,"status":48,"city":49,"state":50,"zip":71,"country":52,"countryCode":53,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"Clinic Hospital of Barcelona","08036",{"type":55,"coordinates":73},[57,58],{"lat":58,"lon":57},[76,80,82,83],{"name":77,"role":38,"phone":78,"phoneExt":65,"email":79},"Maurizio d'Anna, MD","0034 93 227 54 00","danna@clinic.cat",{"name":81,"role":38,"phone":78,"phoneExt":65,"email":65},"Javier Sanchez Macià, MD",{"name":77,"role":35,"phone":65,"phoneExt":65,"email":65},{"name":81,"role":68,"phone":65,"phoneExt":65,"email":65},{"facility":85,"status":48,"city":86,"state":50,"zip":87,"country":52,"countryCode":53,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Hospital Univesitari de Bellvitge","L'Hospitalet de Llobregat","08907",{"type":55,"coordinates":89},[90,91],2.10028,41.35967,{"lat":91,"lon":90},[94,97,99,100],{"name":95,"role":38,"phone":96,"phoneExt":65,"email":65},"Sergi Beato, MD","0034 932 60 75 00",{"name":98,"role":38,"phone":96,"phoneExt":65,"email":65},"Andreu Alabat, MD",{"name":95,"role":35,"phone":65,"phoneExt":65,"email":65},{"name":98,"role":68,"phone":65,"phoneExt":65,"email":65},{"type":35,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"Ivan Schwartzmann, MD","Principal Investigator","100559562","eeap-using-moses-20-technology-vs-the-thulium-fiber-laser-in-medium-large-prostates-100559562",false,"NCT06565741","EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates","Prospective and Randomized Analysis of Endoscopic Prostate Enucleation Using Moses 2.0 Technology Versus the New Thulium Fiber Laser in Medium and Large Prostates.","Inclusion Criteria:\n\n* Males aged between 40 and 90 years.\n* Patients who, due to their lower urinary tract symptoms, are candidates for\n\nBPH surgery, including:\n\n* Obstructive urinary symptoms evaluated through IPSS with a score \\>7 and QoL \\> 2 or acute urinary reten on refractory to catheter removal.\n* Obstructive urinary flow evaluated through uroflowmetry with Qmax\\< 15 ml\u002Fs, obstruction demonstrated by pressure\u002Fflow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal.\n\n  * Prostatic volume measured by transabdominal ultrasound, transrectal ultrasound, or magnetic resonance imaging of more than 80 cc.\n  * Prostate-specific antigen (PSA) \\< 4 ng\u002Fml, or with multiparametric prostate magnetic resonance imaging reporting PIRADS \\< 3 or equal to 3 with PSA density \\< 15%.\n\nExclusion Criteria:\n\n* Diagnosis, suspicion, or history of urethral stenosis or urethral surgery.\n* History of prostate surgery or pelvic radiotherapy.\n* Diagnosis or suspicion of prostate cancer or urothelial cancer.\n* Body mass index superior to 30.","MALE","40 Years","90 Years",{"count":115,"type":116},120,"ESTIMATED","INTERVENTIONAL",[119],"NA","Introduction: Endoscopic anatomical enucleation of the prostate (EEAP) with lasers has emerged as an effective and less invasive surgical option compared to traditional methods. Among the various available laser options, Holmium laser and Thulium Fiber laser have stood out as two prominent approaches for performing endoscopic prostate enucleation. These technologies have 3 showcased their effectiveness in ablating prostatic tissue and improving urinary symptoms. Nevertheless, differences in their physical properties and modes of action may impact their success rates and clinical outcomes. In our institution it is standard practice to use one laser or the other according to their availability in the operating room.\n\nPrimary Objective: To demonstrate the superiority of MoLEP over ThuFLEP in terms of enucleation efficiency.\n\nSecondary Objectives: a) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of perioperative bleeding.\n\nb) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of postoperative hospital stay.\n\nc) To demonstrate the non-inferiority of ThuFLEP compared to ThuFLEP in terms of perioperative complications.\n\nd) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in urinary symptoms.\n\ne) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in flowmetric variables.\n\nStudy Type: Prospective, randomized, non-blind, multicentric clinical trial. Intervention: Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.",[122,123,124],"Prostatic Hyperplasia","Surgery","Endoscopic Anatomical Enucleation of the Prostate (EEAP)",[126,127,128,129,130,26],"Medium and Large Prostates","Endoscopic Prostate Enucleation","Endoscopic anatomical enucleation of the prostate (EEAP)","Holmium laser","Thulium Fiber laser","2026-04-23",{"date":133,"type":134},"2026-04-29","ACTUAL",{"date":136,"type":134},"2024-09-03",{"date":138,"type":116},"2028-09",{"name":5,"class":6},3]