[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07101809":3,"trial-entities:NCT07101809":140,"trial-summary:NCT07101809":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":15,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":65,"locations":68,"central_contacts":136,"overall_officials":137,"references":138,"see_also_links":139},"NCT07101809","CP00006","Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology","Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Standard Ureteroscopy With no Suction for the Treatment of Renal Stones: a Prospective, Randomized Trial","RECRUITING","2029-07","2026-07","2026-07-23","2026-05-21","Calyxo, Inc.","INDUSTRY",null,"The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.",[18,19,20,21],"Urolithiasis","Stones, Kidney","Renal Stones","Kidney Stones",[23,24,25],"ureteroscopy","CVAC","SURE","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},150,"ESTIMATED",[34,41],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":40},"DEVICE","Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System","The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).",[39],"Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System",[24],{"type":35,"name":42,"description":43,"armGroupLabels":44},"Standard Ureteroscopy (URS)","Arm Description: This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out.",[42],[46],{"measure":47,"timeFrame":48},"Residual Stone Volume (RSV)","30-Day",[],"ALL","18 Years",false,{"inclusion":54,"exclusion":58,"raw_text":64},[55,56,57],"Candidate for ureteroscopy with laser lithotripsy","Be willing and able to return for and respond to all study-related follow up procedures","Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)",[59,60,61,62,63],"Untreated urinary tract infection at the time of the index procedure","Significant comorbidities","Bladder, ureteral or kidney abnormalities","Pregnant individuals","Unable to meet the treatment and follow up protocol requirements","Inclusion Criteria:\n\n* Candidate for ureteroscopy with laser lithotripsy\n* Be willing and able to return for and respond to all study-related follow up procedures\n* Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)\n\nExclusion Criteria:\n\n* Untreated urinary tract infection at the time of the index procedure\n* Significant comorbidities\n* Bladder, ureteral or kidney abnormalities\n* Pregnant individuals\n* Unable to meet the treatment and follow up protocol requirements",[66,67],"ADULT","OLDER_ADULT",[69,84,97,109,123],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"The University of Alabama at Birmingham","Birmingham","Alabama","35294","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Samuel P. Dransfield, MS","CONTACT","205-641-6620","sdransfield@uabmc.edu",{"lat":82,"lon":83},33.52066,-86.80249,{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":74,"contacts":89,"geoPoint":94},"University of Florida","Gainesville","Florida","32611",[90],{"name":91,"role":78,"phone":92,"email":93},"John Marks","352-273-5618","marksjg@ufl.edu",{"lat":95,"lon":96},29.65163,-82.32483,{"facility":98,"status":8,"city":99,"state":99,"zip":100,"country":74,"contacts":101,"geoPoint":106},"Icahn School of Medicine at Mount Sinai","New York","10029",[102],{"name":103,"role":78,"phone":104,"email":105},"Monali Fatterpekar, PhD","212-241-0751","monali.fatterpekar@mountsinai.org",{"lat":107,"lon":108},40.71427,-74.00597,{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":74,"contacts":114,"geoPoint":120},"MidLantic Urology","Bala-Cynwyd","Pennsylvania","19004",[115],{"name":116,"role":78,"phone":117,"phoneExt":118,"email":119},"Cheryl Zinar, RN, BSN","610-667-0458","Opt. 2","czinar@midlanticurology.com",{"lat":121,"lon":122},40.00761,-75.23407,{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":74,"contacts":128,"geoPoint":133},"The University of Texas at Austin, Dell Medical School","Austin","Texas","78712",[129],{"name":130,"role":78,"phone":131,"email":132},"Swetha Venkataraman","512-495-2201","swetha.venkataraman@austin.utexas.edu",{"lat":134,"lon":135},30.26715,-97.74306,[],[],[],[],{"nct_id":4,"conditions":141,"biomarkers":143},[142,18],"Nephrolithiasis",[],{"nct_id":4,"found":145,"summary":146,"prompt_version":156},true,{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This is a multi-center study where participants are randomly assigned to one of two treatment groups (SURE or standard URS) with equal chances.","completed","Trial of SURE vs. Standard Ureteroscopy for Kidney Stones","This study is comparing two ways to treat kidney stones (urolithiasis): Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System, and standard ureteroscopy (URS). SURE uses a steerable catheter with vision, irrigation, and aspiration to remove stones. Standard URS uses a laser to break stones into small pieces, followed by a stent to help them pass. The goal is to see which method leaves less stone material behind (Residual Stone Volume) after 30 days. You may be able to join if you are an adult who needs ureteroscopy with laser lithotripsy and are willing to attend follow-up appointments. You cannot join if you have an untreated urinary tract infection. The study plans to enroll 150 participants, but its current status is unclear.","The main measurement for success, Residual Stone Volume, is taken 30 days after the procedure.",122,"You would need to be willing and able to return for and respond to all study-related follow-up procedures.","Not stated in the trial record.",[36,42],"v2"]