[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615877":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":79,"collaborators":19,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":19,"enrollmentInfo":91,"targetDuration":19,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":19,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Auris Health, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OTTAVA Robotic System","EXPERIMENTAL","Participants scheduled to undergo a non-emergent inguinal hernia repair (IHR) procedure, and who meet all study eligibility criteria, will be enrolled to receive the IHR procedure with OTTAVA Robotic System. After the hospital discharge, participants will undergo follow-up visits according to the institution's standard of care and complete a final follow-up visit at 30 days post-procedure.",[13],"Device: OTTAVA Robotic System",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Participants will undergo the IHR procedure using OTTAVA Robotic System.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Auris Health, Inc. Clinical Trial","STUDY_DIRECTOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Damaris Pederson, MPH","CONTACT","1 619 708 2607","Dpeders@its.jnj.com",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"Dominic Papandria, MD","16509226723","DPapandr@ITS.JNJ.com",[35,49,59,69],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":19},"Tampa General Hospital","RECRUITING","Tampa","Florida","33606","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-82.45843,27.94752,{"lat":47,"lon":46},{"facility":50,"status":37,"city":51,"state":52,"zip":53,"country":41,"countryCode":42,"cosmosGeoPoint":54,"geoPoint":58,"contacts":19},"Indiana University North Hospital","Carmel","Indiana","46032",{"type":44,"coordinates":55},[56,57],-86.11804,39.97837,{"lat":57,"lon":56},{"facility":60,"status":37,"city":61,"state":62,"zip":63,"country":41,"countryCode":42,"cosmosGeoPoint":64,"geoPoint":68,"contacts":19},"Duke Regional Hospital","Durham","North Carolina","27704",{"type":44,"coordinates":65},[66,67],-78.89862,35.99403,{"lat":67,"lon":66},{"facility":70,"status":37,"city":71,"state":72,"zip":73,"country":41,"countryCode":42,"cosmosGeoPoint":74,"geoPoint":78,"contacts":19},"The University of Texas Health Science Center at Houston","Houston","Texas","77030",{"type":44,"coordinates":75},[76,77],-95.36327,29.76328,{"lat":77,"lon":76},{"type":80,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100615877","safety-and-performance-of-the-ottava-system-in-participants-undergoing-inguinal-hernia-repair-100615877",false,"NCT07298317","Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair","Technology Evaluation in a Multi-Center Study of Safety and Performance of the OTTAVA System","TEMPO","Inclusion Criteria\n\nSubjects must satisfy all inclusion criteria to be eligible for enrollment:\n\n1. Willing and able to provide informed consent\n2. A minimum of 22 years old at time of consent\n3. Scheduled for elective primary inguinal hernia repair\n4. American Society of Anesthesiologists (ASA) classification I, II, or III\n5. Weight less than 227 kilograms (500 pounds)\n\nExclusion Criteria\n\nSubjects who meet any of the exclusion criteria may not be enrolled:\n\n1. Physician determination, including intraoperative finding, that subject is a poor candidate for robotic surgery\n2. Scheduled concomitant surgical procedure, other than lysis of adhesions, groin hernia repair, or umbilical or epigastric hernia repair not requiring mesh\n3. Previous ipsilateral minimally invasive inguinal hernia repair (laparoscopic or robotic)\n4. Previous radical prostatectomy procedure or pelvic irradiation\n5. Hernia with significant scrotal involvement\n6. Emergency surgery\n7. Enrolled in another investigational study that may confound the results of this study\n8. Currently pregnant or will be pregnant at time of procedure\n9. Subject from a vulnerable population, including anyone unable to adequately provide informed consent.","ALL","22 Years",{"count":92,"type":93},30,"ESTIMATED","INTERVENTIONAL",[96],"NA","The purpose of this study is to assess safety and performance of the OTTAVA System, through 30 days postoperative, in participants undergoing robotic-assisted inguinal hernia repair (IHR).",[99],"Hernia, Inguinal","2026-08-03",{"date":102,"type":103},"2026-08-04","ACTUAL",{"date":105,"type":103},"2026-03-11",{"date":107,"type":93},"2026-08-01",{"name":5,"class":6},4]