[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475848":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":23,"responsibleParty":105,"collaborators":107,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":7,"enrollmentInfo":120,"targetDuration":123,"studyType":124,"phases":7,"briefSummary":125,"conditions":126,"keywords":7,"overallStatus":26,"whyStopped":7,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Lohmann & Rauscher","INDUSTRY",null,[9],{"name":10,"affiliation":11,"role":12},"Mike Laukötter, Prof., MD","Klinikum Rheine, Mathias-Spital","PRINCIPAL_INVESTIGATOR",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Daria Trofimenko, MD","CONTACT","+49 (0)2631- 99 6385","Daria.Trofimenko@de.LRmed.com",{"name":20,"role":16,"phone":21,"phoneExt":7,"email":22},"Martin Abel, PhD","+49 (0)2631- 99 6665","Martin.Abel@de.LRmed.com",[24,39,50,61,70,82,93],{"facility":25,"status":26,"city":27,"state":7,"zip":7,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Uniklinik Berlin Charite","RECRUITING","Berlin","Germany","DE",{"type":31,"coordinates":32},"Point",[33,34],13.41053,52.52437,{"lat":34,"lon":33},[37],{"name":38,"role":16,"phone":7,"phoneExt":7,"email":7},"Konstantinos Kouladouros, MD",{"facility":40,"status":26,"city":41,"state":7,"zip":7,"country":28,"countryCode":29,"cosmosGeoPoint":42,"geoPoint":46,"contacts":47},"Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University","Mannheim",{"type":31,"coordinates":43},[44,45],8.46694,49.4891,{"lat":45,"lon":44},[48],{"name":49,"role":16,"phone":7,"phoneExt":7,"email":7},"Sebastian Belle, MD, Prof",{"facility":51,"status":26,"city":52,"state":7,"zip":7,"country":28,"countryCode":29,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Clinic for general, visceral and transplant surgery at the University of Munich","Munich",{"type":31,"coordinates":54},[55,56],11.57549,48.13743,{"lat":56,"lon":55},[59],{"name":60,"role":16,"phone":7,"phoneExt":7,"email":7},"Maria Burian, MD",{"facility":62,"status":63,"city":52,"state":7,"zip":7,"country":28,"countryCode":29,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"Uniklinik MRI","NOT_YET_RECRUITING",{"type":31,"coordinates":65},[55,56],{"lat":56,"lon":55},[68],{"name":69,"role":16,"phone":7,"phoneExt":7,"email":7},"Jeannine Bachmann, MD",{"facility":71,"status":26,"city":72,"state":7,"zip":73,"country":28,"countryCode":29,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationschirurgie","Münster","48149",{"type":31,"coordinates":75},[76,77],7.62571,51.96236,{"lat":77,"lon":76},[80],{"name":81,"role":16,"phone":7,"phoneExt":7,"email":7},"Jennifer Merten, MD",{"facility":83,"status":26,"city":84,"state":7,"zip":85,"country":28,"countryCode":29,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie","Rheine","48431",{"type":31,"coordinates":87},[88,89],7.44055,52.28509,{"lat":89,"lon":88},[92],{"name":10,"role":16,"phone":7,"phoneExt":7,"email":7},{"facility":94,"status":26,"city":95,"state":7,"zip":96,"country":28,"countryCode":29,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onkologie, Hepatologie, Infektiologie und Geriatrie","Tübingen","72076",{"type":31,"coordinates":98},[99,100],9.05222,48.52266,{"lat":100,"lon":99},[103],{"name":104,"role":16,"phone":7,"phoneExt":7,"email":7},"Ulrike Schlempf, MD",{"type":106,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[108],{"name":109,"class":6},"CRI-The Clinical Research Institute GmbH","100475848","suprasorb-cnpendo-used-for-negative-pressure-therapy-in-the-oesophagus-and-rectum-to-support-defect-and-wound-healing-100475848",false,"NCT05476263","Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing","Non-interventional, Observational, Prospective, Multicentre Study in a Routine Clinical Care Setting Using a Marketed Medical Device in Line With the Corresponding IFU in the Intended Patient Population","Velox","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Acute transmural defects, injuries and wounds in oesophagus or rectum, including perforations (iatrogenic or spontaneous) and anastomotic insufficiencies (Index defect)\n* Indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines\n* Signed informed consent for usage of data\n\nExclusion Criteria:\n\n* Pre-existing coagulation disorders with increased risk of bleeding\n* Defects involving the bronchial system (bronchus\u002Ftrachea\u002Fpulmo)\n* Any foreseeable deviation from IFU of Suprasorb® CNP endo\n* Known intolerance or allergy to one or more components of Suprasorb® CNPendo","ALL","18 Years",{"count":121,"type":122},110,"ESTIMATED","3 Months","OBSERVATIONAL","A Post-Market Clinical Follow-up (PMCF) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding Instruction for Use (IFU) in the intended patient population.\n\nPatients will be diagnosed and evaluated for eligibility in routine clinical care by expert centres in the indication of interest. They will be consecutively enrolled into the study provided that all inclusion and exclusion criteria are met and written consent is given to use their clinical routine data according to data privacy regulations.\n\nThe study protocol does not define specific study procedures for patients enrolled. Therapies and procedures during the course of this study will be performed according to the decision of the treating physician based on current applicable medical guidelines and on local policy in clinical routine care.",[127,128],"Esophagus Injury","Rectal Lesion","2025-09-11",{"date":131,"type":132},"2025-09-12","ACTUAL",{"date":134,"type":132},"2024-06-03",{"date":136,"type":122},"2027-09",{"name":5,"class":6},7]