[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509565":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":122,"collaborators":10,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":10,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":137,"studyType":138,"phases":10,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Smith & Nephew, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tula Tympanostomy",null,"Patients undergoing in-office tympanostomy using the Tula® System",[13],"Combination Product: Iontophoresis and tube placement",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"COMBINATION_PRODUCT","Iontophoresis and tube placement","Iontophoretic delivery of TYMBION™ otic anesthetic using the Tula Iontophoresis System and tube insertion using the Tula Tube Delivery System",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Catherine E Whittall, BsC, Ph.D","CONTACT","+44 7841 868997","catherine.whittall@smith-nephew.com",[27,52,67,81,93,108],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Advanced ENT and Allergy","RECRUITING","Louisville","Kentucky","40220","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-85.75941,38.25424,{"lat":39,"lon":38},[42,47,50],{"name":43,"role":23,"phone":44,"phoneExt":45,"email":46},"Jennifer Leonard","502-893-0159","1185","jleonard@advancedentandallergy.com",{"name":48,"role":49,"phone":10,"phoneExt":10,"email":10},"Colin A Neumann, MD","PRINCIPAL_INVESTIGATOR",{"name":51,"role":49,"phone":10,"phoneExt":10,"email":10},"Andrew R Gould, MD",{"facility":53,"status":29,"city":54,"state":55,"zip":56,"country":33,"countryCode":34,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Regional Otolaryngology Head and Neck Associates","Cherry Hill","New Jersey","08034",{"type":36,"coordinates":58},[59,60],-75.03073,39.93484,{"lat":60,"lon":59},[63,65],{"name":64,"role":23,"phone":10,"phoneExt":10,"email":10},"Megan Morgan",{"name":66,"role":49,"phone":10,"phoneExt":10,"email":10},"Ryan D Walker, MD",{"facility":68,"status":29,"city":69,"state":55,"zip":70,"country":33,"countryCode":34,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Rutgers Robert Wood Johnson Medical School","New Brunswick","08901",{"type":36,"coordinates":72},[73,74],-74.45182,40.48622,{"lat":74,"lon":73},[77,79],{"name":78,"role":23,"phone":10,"phoneExt":10,"email":10},"Kelvin M Kwong",{"name":80,"role":49,"phone":10,"phoneExt":10,"email":10},"Kelvin M Kwong, MD",{"facility":82,"status":29,"city":83,"state":83,"zip":84,"country":33,"countryCode":34,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Columbia University Vagelos College of Physicians and Surgeons","New York","10032",{"type":36,"coordinates":86},[87,88],-74.00597,40.71427,{"lat":88,"lon":87},[91],{"name":92,"role":49,"phone":10,"phoneExt":10,"email":10},"Lawrence Lustig, MD",{"facility":94,"status":29,"city":95,"state":96,"zip":97,"country":33,"countryCode":34,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Ogden Clinic - Professional Center North","Ogden","Utah","84403",{"type":36,"coordinates":99},[100,101],-111.97383,41.223,{"lat":101,"lon":100},[104,106],{"name":105,"role":23,"phone":10,"phoneExt":10,"email":10},"Ashley Erickson",{"name":107,"role":49,"phone":10,"phoneExt":10,"email":10},"Douglas K Anderson, MD",{"facility":109,"status":29,"city":110,"state":96,"zip":111,"country":33,"countryCode":34,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Peak Pediatric Ear, Nose and Throat","Provo","84604",{"type":36,"coordinates":113},[114,115],-111.65853,40.23384,{"lat":115,"lon":114},[118,120],{"name":119,"role":23,"phone":10,"phoneExt":10,"email":10},"Jordan C Schramm",{"name":121,"role":49,"phone":10,"phoneExt":10,"email":10},"Jordan C Schramm, MD",{"type":123,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100509565","evaluation-of-outcomes-following-in-office-tympanostomy-using-the-tula-system-a-prospective-multi-center-registry-100509565",false,"NCT05915078","Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry","Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry","Inclusion Criteria:\n\n* Patients ages 6 months through 17 years of age (inclusive) at time of tympanostomy in-office using the Tula® System\n* Patients who are candidates for in-office tube placement using the Tula System according to the System Instructions For Use\n\nExclusion Criteria:\n\n* Patients who are wards are not included","ALL","6 Months","17 Years",{"count":135,"type":136},200,"ESTIMATED","2 Years","OBSERVATIONAL","This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation.\n\nThe FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).",[141,142,143],"Otitis Media With Effusion","Acute Otitis Media","Otitis Media",[145,146,147,148,149],"Otitis media","pediatric","tympanostomy","office procedure","local anesthesia","2024-07-19",{"date":152,"type":153},"2024-07-23","ACTUAL",{"date":155,"type":153},"2023-06-15",{"date":157,"type":136},"2027-06-30",{"name":5,"class":6},6]