[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477237":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":97,"collaborators":99,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":18,"enrollmentInfo":112,"targetDuration":18,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":18,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Laboratoires Gilbert","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Patients with peak nasal flow performed","OTHER","This arm is made up of major patients. Nasal flow point measurements will be performed at D0 and D3.",[13],"Device: Measurement of peak nasal flow.",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B: No peak nasal flow","NO_INTERVENTION","This arm is made up of minor patients. Unlike arm A, nasal flow measurements will not be performed at D0 and D3.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Measurement of peak nasal flow.","Peak nasal flow measurements will be performed before and after the first use of the spray at D0, as well as after the use of the spray at the medical office at D3 (only for arm A).",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Carine BRUNEL","CONTACT","+33 (0)1 45 39 50 21","cbrunel@labogilbert.fr",[32,51,63,77,87],{"facility":33,"status":34,"city":35,"state":18,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Cabinet Médical","RECRUITING","Blainville-sur-Orne","14550","France","FR",{"type":40,"coordinates":41},"Point",[42,43],-0.30061,49.22913,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":49,"email":50},"Dr. Pauline LE GALL","(0)2 31 44 73 49","+33","docteur.legallpauline@gmail.com",{"facility":52,"status":34,"city":53,"state":18,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Cabinet Médical Caen","Caen","14000",{"type":40,"coordinates":56},[57,58],-0.35912,49.18585,{"lat":58,"lon":57},[61],{"name":62,"role":28,"phone":18,"phoneExt":18,"email":18},"Pascal MABIRE, Dr",{"facility":64,"status":34,"city":65,"state":18,"zip":66,"country":37,"countryCode":38,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"MSP du Haut Anjou","Châteauneuf-sur-Sarthe","49330",{"type":40,"coordinates":68},[69,70],-0.48848,47.68087,{"lat":70,"lon":69},[73],{"name":74,"role":28,"phone":75,"phoneExt":49,"email":76},"Dr. Anne-Charlotte ROCFORT","(0)978080400","dr.rocfort@gmail.com",{"facility":78,"status":79,"city":80,"state":18,"zip":81,"country":37,"countryCode":38,"cosmosGeoPoint":82,"geoPoint":86,"contacts":18},"Cabinet Médical Gainneville","WITHDRAWN","Gainneville","76700",{"type":40,"coordinates":83},[84,85],0.26164,49.51845,{"lat":85,"lon":84},{"facility":88,"status":89,"city":90,"state":18,"zip":91,"country":37,"countryCode":38,"cosmosGeoPoint":92,"geoPoint":96,"contacts":18},"ALYATEC","COMPLETED","Strasbourg","67000",{"type":40,"coordinates":93},[94,95],7.74553,48.58392,{"lat":95,"lon":94},{"type":98,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[100],{"name":101,"class":10},"EVAMED","100477237","safety-and-performance-assessment-of-the-decongestant-seawater-spray-pocket-valve-enriched-with-essential-oils-in-patients-with-acute-rhinitis-associated-with-nasal-obstruction-devalpo-100477237",false,"NCT05494346","Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: \"DEVALPO\"","Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils","DEVALPO","Inclusion Criteria:\n\n* 1\\. Patient ≥ 12 years.\n* 2\\. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.\n* 3\\. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient who has given assent and whose legal guardians have given written consent prior to any study-specific procedure.\n* 4\\. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.\n* 5\\. Patient affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* 1\\. Pregnant and\u002For breastfeeding woman\n* 2\\. Hypersensitivity to seawater and\u002For known allergies to any of the ingredients of the spray.\n* 3\\. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and\u002For respiratory insufficiency.\n* 4\\. Patients with uncontrolled asthma (GINA score greater than or equal to 4)\n* 5\\. Patients undergoing allergy desensitization\n* 6\\. Patients suffering from chronic nasal obstruction due to a deformation of the nasal wall or nasal polyps. creams or gels.\n* 7\\. Patients taking local and systemic vasoconstrictors, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics.\n* 8\\. Concomitant use of other nasal sprays, essential oils for local nasal use, creams, or gels for the nose.\n* 9\\. Patients under guardianship, conservatorship, or legal protection.","ALL","12 Years",{"count":113,"type":114},101,"ESTIMATED","INTERVENTIONAL",[117],"NA","The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.",[120,121,122,123,124],"Acute Rhinitis","Nasal Obstruction","Rhinosinusitis","Rhinopharyngitis","Allergic Rhinitis","2025-09-19",{"date":127,"type":128},"2025-09-25","ACTUAL",{"date":130,"type":128},"2023-06-23",{"date":132,"type":114},"2026-06-30",{"name":5,"class":6},5]