[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645126":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":101,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Hospitales Universitarios Virgen del Rocío","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ClearPetra Vacuum-Assisted Ureteral Access Sheath","EXPERIMENTAL","Flexible ureteroscopy (RIRS) for intrarenal lithiasis (1-3 cm) using the ClearPetra® ureteral access sheath (Coloplast) - a tip-flexible sheath with integrated continuous vacuum aspiration system for active removal of stone fragments and irrigation fluid throughout the procedure. Laser lithotripsy (Holmium:YAG or Thulium) is applied for stone fragmentation. Accessory instruments (retrieval basket, stone cone) are used per standardised protocol. Follow-up includes non-contrast CT at 1 and 3 months post-intervention.",[13],"Device: ClearPetra ureteral access sheath",{"label":15,"type":16,"description":17,"interventionNames":18},"Navigator® Standard Rigid Ureteral Access Sheath","ACTIVE_COMPARATOR","Flexible ureteroscopy (RIRS) for intrarenal lithiasis (1-3 cm) using the Navigator® ureteral access sheath (Boston Scientific) - a standard rigid sheath without active aspiration. Laser lithotripsy (Holmium:YAG or Thulium) is applied for stone fragmentation. Accessory instruments (retrieval basket, stone cone) are used per standardised protocol. Follow-up includes non-contrast CT at 1 and 3 months post-intervention",[19],"Device: Navigator ureteral access sheath",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","ClearPetra ureteral access sheath","Tip-flexible ureteral access sheath with integrated continuous vacuum aspiration system (Coloplast). Placed transurethrally prior to flexible ureteroscopy to maintain stable ureteral access and actively evacuate stone fragments and irrigation fluid throughout the RIRS procedure. Used in combination with laser lithotripsy (Holmium:YAG or Thulium) for fragmentation of intrarenal stones of 1-3 cm. Accessory instruments (retrieval basket, stone cone) employed per standardised intraoperative protocol.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Navigator ureteral access sheath","Standard rigid ureteral access sheath without active aspiration mechanism (Boston Scientific). Placed transurethrally prior to flexible ureteroscopy to maintain stable ureteral access during the RIRS procedure. Used in combination with laser lithotripsy (Holmium:YAG or Thulium) for fragmentation of intrarenal stones of 1-3 cm. Accessory instruments (retrieval basket, stone cone) employed per standardised intraoperative protocol.",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Paula Rodríguez-Marcos, MD","Department of Urology. Unit of Urolithiasis. Virgen del Rocio University Hospital, Seville, Spain","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":39},"Rafael A Medina-López, PhD","Department of Urology. Unit of Uro-Oncology. Virgen del Rocio University Hospital, Seville, Spain","STUDY_DIRECTOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Miguel A. Gómez-Luque, MD","CONTACT","+34623976808","miguel.gomez.luque.sspa@juntadeandalucia.es",[47],{"facility":48,"status":26,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Virgen del Rocio University Hospital","Seville","41013","Spain","ES",{"type":54,"coordinates":55},"Point",[56,57],-5.97317,37.38283,{"lat":57,"lon":56},[60],{"name":61,"role":43,"phone":44,"phoneExt":26,"email":45},"Miguel A Gómez-Luque, MD",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100645126","access-sheaths-with-aspiration-for-renal-retrograde-surgery-randomized-comparative-outcomes-100645126",false,"NCT07678255","Access Sheaths With Aspiration for Renal RetrOgrade Surgery, Randomized CompArative Outcomes","ACCESS SHEATHS WITH ASPIRATION FOR RETROGRADE RENAL SURGERY, RANDOMIZED COMPARATIVE OUTCOMES","ARROCA01","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of intrarenal lithiasis with maximum stone diameter of 1-3 cm on preoperative non-contrast abdomino-pelvic CT scan\n* Candidate for treatment by flexible ureteroscopy (RIRS) as indicated by the treating urologist\n* Attended at the Department of Urology, Hospital Universitario Virgen del Rocío (Seville, Spain)\n* Willing and able to provide written informed consent\n* Able to comply with the study follow-up schedule (CT scan at 1 and 3 months post-intervention)\n\nExclusion Criteria:\n\n* Active urinary tract infection or urosepsis at the time of the planned intervention\n* Known ureteral stricture precluding passage of a ureteral access sheath\n* Pregnancy\n* Prior urinary diversion incompatible with transurethral access (e.g., urinary conduit, neobladder)\n* Bleeding disorder or anticoagulant\u002Fantiplatelet therapy that cannot be safely interrupted perioperatively\n* Stone diameter \\\u003C1 cm or \\>3 cm on preoperative CT\n* Inability to provide informed consent (cognitive impairment, language barrier without interpreter availability)\n* Simultaneous participation in another clinical trial that could interfere with the outcomes of this study","ALL","18 Years",{"count":75,"type":76},156,"ESTIMATED","INTERVENTIONAL",[79],"NA","The goal of this clinical trial is to learn whether the ClearPetra ureteral access sheath (Coloplast) is more effective than the Navigator ureteral access sheath (Boston Scientific) in treating intrarenal kidney stones of 1-3 cm in adult patients undergoing flexible ureteroscopy (RIRS). The main questions it aims to answer are:\n\nDoes ClearPetra achieve a higher stone-free rate at 1 month post-intervention compared to Navigator, as assessed by non-contrast abdominal-pelvic CT scan?\n\nDoes ClearPetra reduce total surgical time compared to Navigator?\n\nDoes ClearPetra lower the retreatment rate at 3 months compared to Navigator?\n\nDoes ClearPetra present a rate of clinically significant complications (Clavien-Dindo ≥ II) that is lower than or similar to Navigator?\n\nResearchers will compare flexible ureteroscopy using the ClearPetra vacuum-assisted flexible ureteral access sheath to flexible ureteroscopy using the Navigator standard rigid ureteral access sheath, to see if ClearPetra leads to higher stone clearance rates while maintaining a comparable safety profile.\n\nParticipants will:\n\nUndergo flexible ureteroscopy (RIRS) using one of two randomly assigned ureteral access sheaths (ClearPetra or Navigator), determined by computer-generated randomization immediately before surgery\n\nHave a non-contrast abdominal-pelvic CT scan at 1 month post-intervention to assess stone-free status\n\nHave a non-contrast abdominal-pelvic CT scan at 3 months post-intervention to evaluate residual fragments and the need for retreatment\n\nAttend follow-up visits at 1 month and 3 months post-surgery for clinical assessment and complication recording\n\nThe study will be conducted at the Urology Department of Hospital Universitario Virgen del Rocío (Seville, Spain), a tertiary reference centre. A total of 156 patients will be randomized in a 1:1 ratio (78 per group), with pre-defined subgroup analyses stratified by stone size (1-2 cm vs. \\>2 cm). The outcome assessor evaluating CT images for stone-free rate will be blinded to treatment allocation (single-blind).",[82,83,84,85],"Urolithiasis","Nephrolithiasis","Kidney Calculi","Ureteroscopy",[87,88,89,90,91,92,93,94,95,96,97,98,99,100],"Flexible ureteroscopy","Retrograde intrarenal surgery","RIRS","Ureteral access sheath","ClearPetra","Navigator","Stone-free rate","Laser lithotripsy","Intrarenal lithiasis","Vacuum-assisted sheath","Clavien-Dindo","Stone fragmentation","Endourology","Urinary tract calculi","NOT_YET_RECRUITING","2026-06-25",{"date":104,"type":105},"2026-07-01","ACTUAL",{"date":107,"type":76},"2026-09-15",{"date":109,"type":76},"2030-05",{"name":5,"class":6},1]