[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07514351":3,"trial-entities:NCT07514351":88,"trial-summary:NCT07514351":91},{"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":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":57,"locations":60,"central_contacts":75,"overall_officials":79,"references":86,"see_also_links":87},"NCT07514351","STUDY20260380","FANS vs CVAC for Medium to Large Stones","Randomized Controlled Trial of Flexible and Navigable Suction (FANS) vs. CVAC Suction Ureteroscope for Medium to Large Stones","NOT_YET_RECRUITING","2028-12","2026-03","2026-04-07","2026-06","Ohio State University","OTHER",true,"Improvements in ureteroscopes have led to improved stone free rates. Two new devices (FANS - Flexible and Navigable Suction) and the CVAC ureteroscope have never been compared head to head. This trial will compare these two new suction ureteroscope technologies against each other","Ureteroscopy (URS) is recommended by the American Urological Association for surgical treatment of kidney stones \\\u003C 2 cm in linear dimension. Although historically shock wave lithotripsy was the most common surgical treatment, since 2013 ureteroscopy has become the most common surgical treatment for kidney stones. There have been great advancements to ureteroscopic technology with improvements in laser technology leading to more efficient and complete stone ablation\u002F fragmentation. However, stone free rates were still suboptimal, with some series reporting stone free rates of 55% after URS. However, in the last couple of years the introduction of suction technology, specifically Flexible and Navigable Suction (FANS) sheaths and the CVAC scope by Calyxo have changed the paradigm of kidney stone treatment. CVAC is essentially a larger ureteroscope with a large 7F working channel that allows for aspiration of stone fragments created during laser lithotripsy. A standard ureteroscope has a working channel of only 3.6 F so fragments cannot be aspirated through this. These new suction technologies allow the surgeon to actively remove stone fragments, thereby increasing the immediate and long-term stone free rate, instead of waiting for fragments to pass after the surgery.",[19,20],"Kidney Stones","Nephrolithiasis",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},159,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","ureteroscopy","ureteroscopy will be performed with flexible and navigable suction sheaths",[35],"FANS",{"type":31,"name":37,"description":38,"armGroupLabels":39},"CVAC","CVAC suction ureteroscopy will be used",[37],[41],{"measure":42,"description":43,"timeFrame":44},"stone free rate","Journal of Endourology definitions using CT evidence","up to six weeks",[],"ALL","18 Years",null,false,{"inclusion":51,"exclusion":54,"raw_text":56},[52,53],"Clinical diagnosis of Nephrolithiasis","Total linear stone diameter 8-20 mm in size",[55],"Severe medical comorbidities causing inability to undergo general anesthesia","Inclusion Criteria:\n\n* Clinical diagnosis of Nephrolithiasis\n* Total linear stone diameter 8-20 mm in size\n\nExclusion Criteria:\n\n* Severe medical comorbidities causing inability to undergo general anesthesia",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":13,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":72},"Columbus","Ohio","43212","United States",[67],{"name":68,"role":69,"phone":70,"email":71},"Matthew Lee","CONTACT","614-293-8155","matthew.lee@osumc.edu",{"lat":73,"lon":74},39.96118,-82.99879,[76],{"name":77,"role":69,"phone":78,"email":71},"Matthew Lee, MD","614-685-9181",[80,82,84],{"name":77,"affiliation":13,"role":81},"PRINCIPAL_INVESTIGATOR",{"name":83,"affiliation":13,"role":81},"Bodo Knudsen, MD",{"name":85,"affiliation":13,"role":81},"Michael Sourial, MD",[],[],{"nct_id":4,"conditions":89,"biomarkers":90},[20],[],{"nct_id":4,"found":15,"summary":92,"prompt_version":102},{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This study plans to enroll 159 participants to compare two different devices used during ureteroscopy.","completed","FANS vs CVAC for Medium to Large Kidney Stones","This study is comparing two new devices, Flexible and Navigable Suction (FANS) sheaths and the CVAC ureteroscope, used during ureteroscopy (a procedure to remove kidney stones). Both devices help surgeons remove stone fragments more effectively during the procedure. The study wants to see which device leads to a higher \"stone free rate\" (meaning no stones are left behind) up to six weeks after surgery. You might be able to join if you are 18 or older, have a clinical diagnosis of kidney stones (Nephrolithiasis), and your stones are between 8 and 20 millimeters in size. You cannot join if you have severe medical conditions that prevent you from having general anesthesia. The current recruitment status is unclear.","Your stone free rate will be measured up to six weeks after the procedure.",117,"Not specified in the trial record.","Not stated in the trial record.",[32,37],"v2"]