[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496642":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":26,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"GCS Ramsay Santé pour l'Enseignement et la Recherche","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group with PuraStat®","EXPERIMENTAL","Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat®",[13,14],"Procedure: duodenal mucosectomy","Procedure: ampullectomy",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","ACTIVE_COMPARATOR","Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","duodenal mucosectomy","Standard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator.",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"ampullectomy","Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Sarah LEBLANC, MD","CONTACT","622222064","+33","sarahleblanc34@hotmail.com",[39],{"facility":40,"status":41,"city":42,"state":26,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Hôpital Privé Jean Mermoz","RECRUITING","Lyon","France","FR",{"type":46,"coordinates":47},"Point",[48,49],4.84789,45.74906,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":26,"phoneExt":26,"email":53},"s.leblanc@gelmad.fr",{"type":55,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[57],{"name":58,"class":59},"Euraxi Pharma","INDUSTRY","100496642","haemostatic-gel-prophylaxis-for-post-duodenal-endoscopic-resection-bleeding-100496642",false,"NCT05746884","Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding","PURASTAT","Inclusion Criteria:\n\nAmpullary lesions\n\n* Single ampullary lesion ≥ 10mm\n* Resection via hot ampullectomy, injection\u002FEndoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions\n* ≤ 2 lesions\n* Lesion ≥15mm\n* Resection via hot Endoscopic mucosal resection\n* Morphology: 0-Is, 0-IIa\u002Fb\u002Fc or combination, submucosal lesions\n\nExclusion Criteria:\n\n* Inability to provide informed consent (including people with cognitive impairment);\n* Pregnant or breastfeeding women;\n* Allergy to PuraStat®;\n* \"Cold\" mucosal endoscopic resection;\n* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;\n* Participating patient, or in a period of exclusion from another clinical trial;\n* Patient not benefiting from a social security scheme.","ALL","18 Years",{"count":70,"type":71},234,"ESTIMATED","INTERVENTIONAL",[74],"NA","The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.",[77],"Duodenal Bleeding","2026-02-24",{"date":80,"type":81},"2026-02-27","ACTUAL",{"date":83,"type":81},"2023-08-21",{"date":85,"type":71},"2028-09-30",{"name":5,"class":6},1]