[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552849":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":26,"responsibleParty":47,"collaborators":49,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":26,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":26,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":26},{"fullName":5,"class":6},"Pharmaluce srl","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Munatoril","EXPERIMENTAL","Experimental: Munatoril From day 1 to day 7 postoperatively: SID administration of Munatoril® Aerosol Combo by aerosol therapy, in the morning + TID administration of an over-the-counter sterile isotonic solution by Lavonase® syringe.\n\nFrom day 8 to day 14 postoperatively:\n\nSID administration of Munatoril® Aerosol Combo via Lavonase® syringe, in the morning + TID administration of an over-the-counter sterile isotonic solution, via Lavonase® syringe.\n\n\\- From postoperative day 15 to day 29: TID administration via Lavonase® syringe of an isotonic solution obtained by diluting Munatoril® Aerosol Combo hypertonic solution",[13],"Device: Munatoril Aerosol Combo",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Active Comparator: Control Day 1 to day 7 postoperative: SID administration of Hypertonic Solution by aerosol therapy, in the morning + TID administration of an over-the-counter sterile isotonic solution by Lavonase® syringe.\n\nPostoperative day 8 to day 14:\n\nSID administration of hypertonic solution via Lavonase® syringe, in the morning + TID administration of an over-the-counter sterile isotonic solution, via Lavonase® syringe.\n\n\\- Postoperative day 15 to day 29: TID administration via Lavonase® syringe of an isotonic solution.",[19],"Device: Iperclenny",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Munatoril Aerosol Combo","Munatoril® Aerosol Combo is a Medical Device that contains:\n\n5 ml single-dose vials of sterile, 3% hypertonic, near-neutral pH bromine-iodine saline solution, based on Cervia integral sea salt, salso-bromo-iodine saline mother water from the Cervia Thermal Baths and hyaluronic acid with high molecular weight.\n\nLavonase® syringe with blue nebulizer valve (microsol), 10 ml, Medical Device for the administration of solutions in nebulized form within the nasal cavities and nasopharynx.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Iperclenny","Hypertonic and Isotonic solution present on market in italy.",[15],[32],"Isoclenny",[34],{"name":35,"affiliation":36,"role":37},"Laura Tedeschi, Master","Gruppo FarmaImpresa","STUDY_CHAIR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Nader Nassif, Doctor","CONTACT","0303996226","nader.nassif@asst-spedalicivili.it",{"name":45,"role":41,"phone":42,"phoneExt":26,"email":46},"Chiara Pastorelli, Master","c.pastorelli@erbozeta.com",{"type":48,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[50],{"name":36,"class":6},"100552849","study-on-the-efficacy-and-safety-of-a-device-for-post-op-recovery-in-pediatric-adenectomyadenotonsillectomy-100552849",false,"NCT06478433","Study on the Efficacy and Safety of a Device for Post-op Recovery in Pediatric Adenectomy\u002FAdenotonsillectomy.","\"Efficacy and Safety Study of the Medical Device Munatoril® Aerosol Combo in the Recovery of Nasal Homeostasis in Pediatric Patients Undergoing Adenoidectomy or Adenotonsillectomy.\"","Inclusion Criteria:\n\n* Patients of either sex aged 2 to 17 years who are candidates for adenoidectomy or adenotonsillectomy surgery.\n* Acquisition and signing of informed consent by the legal guardian.\n\nExclusion Criteria:\n\n* Syndromic patients.\n* Patients allergic to any substance in the study formulations.\n* Patients who have used intranasal corticosteroids, topical or systemic corticosteroids, or any intranasal medication in the week prior to study entry.\n* Active respiratory infection in the 2 weeks prior to study entry.\n* Patients with a history of chronic epistaxis or immunodeficiency.","ALL","2 Years","17 Years",{"count":62,"type":63},90,"ESTIMATED","INTERVENTIONAL",[66],"NA","The objective of this prospective pre-market interventional clinical study is to evaluate the efficacy and safety of the medical device Munatoril® Aerosol Combo in its different modalities of use, through the analysis of clinical and subjective outcomes in children operated on adenoidectomy or adenotonsillectomy, compared with a hypertonic solution and an over-the-counter isotonic solution (control group).\n\nThe primary question it aims to answer is whether the components prensent in Munatoril provide a benefit and whether they play a role in the recovery of nasal homeostasis following adeinodectomy and adenotonsillectomy compared with an over-the-counter hypertonic saline solution.\n\nEndpoints Evaluation of subjective longitudinal differences (intragroup over-time change) and differences between study group and control group (intergroup difference) regarding the use of the medical device, obtained following the protocol, with assessment at 8, 15 and 30 days after surgery by Likert Scale Score for tolerability, and at 0, 15 and 30 days by SNOT22 Score and Lund-Kennedy Endoscopic Score for efficacy.\n\nIn addition, there is a recording of any adverse events in both groups at 8, 15 and 30 days post-surgery, and an inter-group comparative evaluation.\n\nParticipants: Pediatric patients who are candidates for adenoidectomy or adenotonsillectomy surgery at the study site facility will be systematically evaluated preoperatively for inclusion in the clinical trial and possibly recruited. Follow-up will last 30 days.",[69,70,71,72],"Adenoidal Disorder","Tonsillitis","Otorhinolaryngologic Diseases","Nasal Disease",[74],"nasal irrigation","NOT_YET_RECRUITING","2024-07-02",{"date":78,"type":79},"2024-07-03","ACTUAL",{"date":81,"type":63},"2024-12-01",{"date":83,"type":63},"2026-06-01",{"name":5,"class":6}]