[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603084":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":39,"collaborators":20,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":20,"enrollmentInfo":53,"targetDuration":20,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":65,"whyStopped":20,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Brno University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Bedside Microenvironment Monitoring Arm","EXPERIMENTAL","Participants in this arm will undergo standard percutaneous drainage of infected walled-off pancreatic necrosis (WOPN) as per clinical indication. In addition, a sterile, biocompatible micro-monitoring probe will be temporarily introduced into the collection to measure local microenvironmental parameters. Measurements will be performed intermittently or continuously for up to 72 hours without compromising drainage function. No investigational drug or therapeutic intervention is administered.",[13],"Device: Miniaturized Intracavitary Monitoring Probe",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Miniaturized Intracavitary Monitoring Probe","A sterile, miniaturized, biocompatible monitoring probe (≤1.5 mm diameter) is temporarily introduced into the cavity of an infected walled-off pancreatic necrosis (WOPN) during standard percutaneous drainage. The device is designed to measure local microenvironmental parameters in situ, such as acidity and related indicators, without interfering with fluid evacuation. Measurements are performed intermittently or continuously for up to 72 hours and are used solely for observational purposes. This intervention is distinct from standard WOPN management, as it allows real-time assessment of local physicochemical conditions, which are not accessible through systemic biomarkers or imaging alone.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Martin Harazim, MD","CONTACT","+420 532 233 052","igek-jip@fnbrno.cz",[28],{"facility":29,"status":20,"city":30,"state":20,"zip":31,"country":32,"countryCode":20,"cosmosGeoPoint":33,"geoPoint":38,"contacts":20},"University Hospital Brno","Brno","62500","Czechia",{"type":34,"coordinates":35},"Point",[36,37],16.60796,49.19522,{"lat":37,"lon":36},{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Martin Harazim","Principal Investigator, Department of Gastroenterology and Intensive Care Medicine","100603084","bedside-monitoring-of-microenvironmental-changes-in-infected-pancreatic-collections-100603084",false,"NCT07131917","Bedside Monitoring of Microenvironmental Changes in Infected Pancreatic Collections","Feasibility, Safety and Clinical Impact of Bedside Microenvironmental Monitoring in Infected Walled-Off Pancreatic Necrosis During Standard Percutaneous Drainage","WOPN-MONITOR","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of walled-off pancreatic necrosis (WOPN) confirmed by imaging (CT, MRI, or EUS)\n* Clinical suspicion or confirmation of infection in WOPN (e.g., fever, elevated inflammatory markers, positive culture)\n* Planned percutaneous drainage as part of standard care\n* Ability to provide informed consent (or surrogate consent where applicable)\n\nExclusion Criteria:\n\n* Coagulopathy not correctable prior to intervention (e.g., INR \\> 2.0 or platelets \\\u003C 50×10⁹\u002FL)\n* Known allergy or hypersensitivity to materials used in the monitoring probe\n* technical limitations precluding safe probe insertion","ALL","18 Years",{"count":54,"type":55},20,"ESTIMATED","INTERVENTIONAL",[58],"NA","This pilot clinical study aims to assess the feasibility and clinical relevance of bedside monitoring of microenvironmental conditions within infected walled-off pancreatic necrosis (WOPN).\n\nWOPN is a serious complication of acute pancreatitis, often associated with infection, organ failure, and the need for drainage or surgical intervention. Although infection is a key factor in prognosis, little is known about the local chemical environment inside the infected collections.\n\nIn this study, a sterile, miniaturized probe will be temporarily introduced into the necrotic cavity during standard percutaneous drainage. The goal is to record local microenvironmental parameters (such as acidity or related values) and monitor their changes over time.\n\nBy comparing these values with clinical data (e.g., inflammatory markers, microbiology, need for surgery), the study aims to determine whether such measurements can provide additional information about infection severity and treatment response.\n\nThe study does not involve any experimental treatment. All patients will receive standard medical care, including antibiotics, imaging, and drainage according to international guidelines.\n\nParticipation is voluntary. Only patients who provide informed consent will be enrolled.",[61,62],"Pancreatitis","Walled Off Pancreatic Necrosis",[64],"pancreatitis","NOT_YET_RECRUITING","2025-08-13",{"date":68,"type":69},"2025-08-20","ACTUAL",{"date":71,"type":55},"2025-11-01",{"date":73,"type":55},"2026-06-15",{"name":41,"class":6},1]