[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629120":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":48,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":79,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Medical University Innsbruck","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fiber-Optic Navigation-Assisted TIPS","EXPERIMENTAL","Patients undergo transjugular intrahepatic portosystemic shunt (TIPS) creation using fiber-optic navigation technology to assist catheter and guidewire navigation. The procedure is performed according to routine clinical practice at a tertiary interventional radiology center. Procedural parameters including number of puncture attempts, fluoroscopy time, radiation exposure, total procedure time, technical success, and procedure-related complications are prospectively recorded.",[13],"Device: Fiber-Optic Navigation System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Fiber-Optic Navigation System","Use of a fiber-optic shape sensing navigation system to assist catheter and guidewire navigation during transjugular intrahepatic portosystemic shunt (TIPS) creation. The system provides real-time three-dimensional visualization of endovascular devices and is used to support portal vein access during the procedure performed according to routine clinical practice.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Malik Galijasevic, MD, PhD","CONTACT","+4351250483248","malik.galijasevic@i-med.ac.at",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Medical University of Innsbruck","Innsbruck","Tyrol","6020","Austria","AT",{"type":36,"coordinates":37},"Point",[38,39],11.39454,47.26266,{"lat":39,"lon":38},[42,43,46],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":44,"role":45,"phone":20,"phoneExt":20,"email":20},"Alexander Loizides, MD, Prof.","PRINCIPAL_INVESTIGATOR",{"name":23,"role":47,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100629120","fiber-optic-navigation-during-tips-creation-a-prospective-pilot-study-100629120",false,"NCT07470515","Fiber-Optic Navigation During TIPS Creation: A Prospective Pilot Study","Fiber-Optic Navigation During Transjugular Intrahepatic Portosystemic Shunt Creation: A Prospective Pilot Study Evaluating Procedural Parameters","FLIGHT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Clinical indication for transjugular intrahepatic portosystemic shunt (TIPS) creation according to standard clinical practice (e.g., refractory ascites or variceal bleeding)\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent\n* Pregnancy or breastfeeding\n* Absolute contraindications to TIPS according to current clinical standards (e.g., severe right heart failure, uncontrolled systemic infection)\n* Participation in another clinical study that may interfere with the results of this study","ALL","18 Years",{"count":61,"type":62},30,"ESTIMATED","INTERVENTIONAL",[65],"NA","Transjugular intrahepatic portosystemic shunt (TIPS) creation is an established minimally invasive treatment for complications of portal hypertension such as refractory ascites and variceal bleeding. A technically challenging step of the procedure is the puncture of the portal vein from the hepatic vein, which is usually performed under fluoroscopic guidance and may require multiple puncture attempts.\n\nThis prospective pilot study evaluates the use of fiber-optic navigation technology during TIPS creation. The system allows real-time three-dimensional visualization of guidewires and catheters and may improve spatial orientation during the procedure.\n\nApproximately 30 patients with a clinical indication for TIPS placement will be included. The study will assess procedural parameters such as the number of puncture attempts, fluoroscopy time, radiation exposure, procedure duration, technical success, and complications.\n\nThe results may help to improve procedural efficiency and radiation safety during TIPS interventions.",[68,69,70,71],"Liver Cirrhosis","Refractory Ascites","Variceal Bleeding","Portal Hypertension",[73,71,74,75,76,77,78],"TIPS","Interventional Radiology","Fiber-Optic Navigation","Image-Guided Intervention","Endovascular Navigation","Radiation Reduction","NOT_YET_RECRUITING","2026-03-10",{"date":82,"type":83},"2026-03-13","ACTUAL",{"date":85,"type":62},"2027-01",{"date":87,"type":62},"2028-12",{"name":5,"class":6},1]