[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496642":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":24,"studyPopulation":13,"armGroups":25,"interventions":38,"overallOfficials":13,"centralContacts":48,"locations":55,"responsibleParty":71,"collaborators":73,"id":77,"slug":13,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":13,"enrollmentInfo":85,"targetDuration":13,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":13,"overallStatus":58,"whyStopped":13,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"GCS Ramsay Santé pour l'Enseignement et la Recherche","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Bleeding rate requiring further intervention within 30 days","Rate of clinically significant delayed postoperative bleeding requiring further intervention within 30 days (such as blood transfusion, packed cell transfusion or administration of other blood products, hospitalization or repeat endoscopy)","30 days",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Single-blind, controlled, comparative, randomized, multicentre, international post-marketing follow-up study of a CE marked medical device.","TREATMENT",{"masking":20,"maskingDescription":21,"whoMasked":22},"SINGLE","single blind",[23],"PARTICIPANT","This is a post-marketing follow-up study of a CE marked medical device, controlled, comparative, randomized, multicentre, international single-blind.\n\nThe main objective is to evaluate the efficacy and safety of PuraStat in duodenal endoscopic mucosal resection or ampullectomy.\n\nThis study will be carried out in France in 3 investigative centers. The duration of patient participation in the study is approximately 37 days depending on the time between the selection and the endoscopic intervention.",[26,33],{"label":27,"type":28,"description":29,"interventionNames":30},"Experimental Group with PuraStat®","EXPERIMENTAL","Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat®",[31,32],"Procedure: duodenal mucosectomy","Procedure: ampullectomy",{"label":34,"type":35,"description":36,"interventionNames":37},"Control Group","ACTIVE_COMPARATOR","Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion",[31,32],[39,44],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":13},"PROCEDURE","duodenal mucosectomy","Standard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator.",[34,27],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":13},"ampullectomy","Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.",[34,27],[49],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"Sarah LEBLANC, MD","CONTACT","622222064","+33","sarahleblanc34@hotmail.com",[56],{"facility":57,"status":58,"city":59,"state":13,"zip":13,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Hôpital Privé Jean Mermoz","RECRUITING","Lyon","France","FR",{"type":63,"coordinates":64},"Point",[65,66],4.84789,45.74906,{"lat":66,"lon":65},[69],{"name":50,"role":51,"phone":13,"phoneExt":13,"email":70},"s.leblanc@gelmad.fr",{"type":72,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[74],{"name":75,"class":76},"Euraxi Pharma","INDUSTRY","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":86,"type":87},234,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93],"Duodenal Bleeding","2026-02-24",{"date":96,"type":97},"2026-02-27","ACTUAL",{"date":99,"type":97},"2023-08-21",{"date":101,"type":87},"2028-09-30",{"name":5,"class":6},1]