[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"otorhinolaryngologic-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:otorhinolaryngologic-diseases":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":37,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":5},"100544551","phase-1-a-phase-iii-clinical-trial-with-sens-501-in-children-suffering-from-severe-to-profound-hearing-loss-due-to-otoferlin-otof-mutations-100544551",false,"NCT06370351","A Phase I\u002FII Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations","A Phase I\u002FII, Open-ended, Adaptative, Open Label Dose Escalation and Expansion Clinical Trial to Evaluate the Efficacy and Safety of Unilateral Intracochlear Injection of SENS-501 Using an Injection System in Children with Severe to Profound Hearing Loss Due to Otoferlin Gene Mutations","AUDIOGENE","Inclusion Criteria:\n\n* Children (male or female) ≥ 6 to ≤ 31 months at the time of inclusion\n* Severe to profound hearing loss assessed by auditory brainstem response (ABR)\n* Biallelic mutation in the Otoferlin gene\n* Presence of Otoacoustic emissions (OAEs)\n* Documented normal cochlea and internal auditory canals\n* Patients with intact vestibular function\n\nExclusion Criteria:\n\n* History of chronic, acute, or major disease, or unspecified reasons, that in the opinion of the Investigator, makes the participant unsuitable for participation in the study or constitutes an unacceptable risk.\n* Have been dosed in a previous gene therapy clinical trial\n* Patients with a prior or current cochlear implant\n* Any contraindication to the surgery determined by the surgeon or anesthesia determined by the anesthesiologist, or designee, or history of therapy known as ototoxic (e.g., cisplatin, high dose and long treatment with aminoglycosides, etc.) for an extended period (more than 2 weeks).\n* Participation in any other interventional clinical trial\n* Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study or might interfere with the evaluation of study treatment\n* Anticipated noncompliance with the protocol requirements","ALL","6 Months","31 Months",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.",[29,30,31,32,33,34,35,36],"OTOF Gene Mutation","DFNB9","Congenital Deafness","Hearing Disorders","Ear Diseases","Otorhinolaryngologic Diseases","Deafness","Hearing Loss, Sensorineural",[29,38,35,39,15,40,30,41,42,43,44,45],"Hearing impairment","otoferlin","Hearing Loss","Hearing disorder","Cochlear implant","SENS-501","Congenital Hearing loss","Gene therapy","RECRUITING","2024-09-23",{"date":49,"type":50},"2024-09-26","ACTUAL",{"date":52,"type":50},"2024-06-21",{"date":54,"type":22},"2031-07",{"name":56,"class":57},"Sensorion","INDUSTRY",{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":23,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100552849","study-on-the-efficacy-and-safety-of-a-device-for-post-op-recovery-in-pediatric-adenectomyadenotonsillectomy-100552849","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.","2 Years","17 Years",{"count":68,"type":22},90,[70],"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.",[73,74,34,75],"Adenoidal Disorder","Tonsillitis","Nasal Disease",[77],"nasal irrigation","NOT_YET_RECRUITING","2024-07-02",{"date":81,"type":50},"2024-07-03",{"date":83,"type":22},"2024-12-01",{"date":85,"type":22},"2026-06-01",{"name":87,"class":57},"Pharmaluce srl"]