[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647868":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":100,"collaborators":11,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":11,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":128,"whyStopped":11,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Ventaris Surgical Incorporated","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational endourological device used during retrograde intrarenal surgery.","EXPERIMENTAL",null,[13],"Device: RIRS with Investigational Device",[15],{"type":16,"name":17,"description":9,"armGroupLabels":18,"otherNames":11},"DEVICE","RIRS with Investigational Device",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Matt Sprinkel","CONTACT","+1 650 465 6200","matt@ventarissurgical.com",[26,43,59,72,86],{"facility":27,"status":11,"city":28,"state":11,"zip":11,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Hospital Alemán","Buenos Aires","Argentina","AR",{"type":32,"coordinates":33},"Point",[34,35],-58.37723,-34.61315,{"lat":35,"lon":34},[38],{"name":39,"role":22,"phone":40,"phoneExt":41,"email":42},"Head of Clinical Investigations","(011) 4827 7000","2286\u002F 7039","pperez@hospitalaleman.com",{"facility":44,"status":11,"city":45,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Centre hospitalier de l'Universite de Montreal (CHUM)","Montreal","Canada","CA",{"type":32,"coordinates":49},[50,51],-73.58781,45.50884,{"lat":51,"lon":50},[54],{"name":55,"role":22,"phone":56,"phoneExt":57,"email":58},"Research Coordinator","514-890-8000","22931","abbas.guennoun.chum@ssss.gouv.qc.ca",{"facility":60,"status":11,"city":61,"state":11,"zip":11,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"The Chinese University of Hong Kong","Hong Kong","HK",{"type":32,"coordinates":64},[65,66],114.17469,22.27832,{"lat":66,"lon":65},[69],{"name":55,"role":22,"phone":70,"phoneExt":11,"email":71},"3505 2211","francolai@surgery.cuhk.edu.hk",{"facility":73,"status":11,"city":74,"state":11,"zip":11,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Muljibhai Patel Urological Hospital","Nadiād","India","IN",{"type":32,"coordinates":78},[79,80],72.86157,22.69385,{"lat":80,"lon":79},[83],{"name":55,"role":22,"phone":84,"phoneExt":11,"email":85},"912682520328","monil.parmar@mpuh.in",{"facility":87,"status":11,"city":88,"state":11,"zip":11,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Tauranga Urology Research Limited","Tauranga","New Zealand","NZ",{"type":32,"coordinates":92},[93,94],176.16667,-37.68611,{"lat":94,"lon":93},[97],{"name":55,"role":22,"phone":98,"phoneExt":11,"email":99},"(07) 579 0466","marg@urobop.co.nz",{"type":101,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100647868","dison-i---directly-integrated-suction-and-optics-system-for-the-treatment-of-nephrolithiasis-100647868",false,"NCT07712861","DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis","DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis- A Multicenter Prospective Pilot Study","DISON I","Inclusion Criteria:\n\n1. Diagnosis of calyceal and\u002For renal pelvis calculi\n2. Age from 18 through 85 years\n3. Maximum stone diameter between 0.5cm - 2.0cm as assessed by Non-Contrast CT scan (≤ 2 mm slice thickness) within 90 days prior to treatment\n4. Willing and able to comply with all study requirements\n5. Signs study-specific informed consent form\n\nExclusion Criteria:\n\n1. Diagnosis of calculus of the ureter\n2. BMI ≥ 42\n3. Significant renal impairment: stage 3a CKD or higher (eGFR \\\u003C59mL\u002Fmin)\n4. Active infection, including urinary tract infection\n5. Urological anatomic\u002Fcongenital abnormalities\n6. Previous history of struvite stone in the same renal unit\n7. Taking anticoagulants that cannot be stopped before and after procedure or known coagulopathy or platelet disorder (except aspirin below 100mg\u002Fd)\n8. History of gross hematuria\n9. Solitary functioning kidney\n10. Known allergy to device materials\n11. Any severe illness that would prevent complete study participation or confound study results\n12. Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days, congestive heart failure - NYHA Class IV), pulmonary disease or uncontrolled diabetes.\n13. History of open-heart surgery, or cardiac arrest \\\u003C 180 days prior to the date of informed consent\n14. ASA III or higher\n15. Taking systemic immune suppressants\n16. Dementia or psychiatric condition that prevents the participant from completing required follow up\n17. Contraindication to both general and spinal anesthesia\n18. Participating in another investigational study that could affect responses to the study device\n19. Unwilling to accept a transfusion should one be required\n20. Pregnant or considering getting pregnant within the next 3 months\n21. Undergoing bilateral ureteroscopy","ALL","18 Years","85 Years",{"count":114,"type":115},75,"ESTIMATED","INTERVENTIONAL",[118],"NA","A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational device during retrograde intrarenal surgery for the treatment of renal calculi.",[121,122,123],"Kidney Stones","Urolithiasis","Nephrolithiasis",[125,126,127],"kidney stones","medical device","Urological procedure","NOT_YET_RECRUITING","2026-08-02",{"date":131,"type":132},"2026-08-05","ACTUAL",{"date":134,"type":115},"2026-10",{"date":136,"type":115},"2028-08",{"name":5,"class":6},5]