[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652552":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":63,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":30,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":30,"enrollmentInfo":79,"targetDuration":30,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":99,"whyStopped":30,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EarFlo Intervention Arm","EXPERIMENTAL","Participants in this single arm will undergo baseline assessments, use the EarFlo device once during a clinic visit, and complete post-use assessments to evaluate short-term changes in ear symptoms and middle ear function.",[13],"Device: EarFlo Device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","EarFlo Device","The EarFlo device is a non-invasive, cup-based device used during swallowing to help equalize middle ear pressure. By delivering a controlled puff of air through the nose during swallowing, it assists Eustachian tube opening to relieve negative middle ear pressure. Participants will use the device once during a single clinic visit while drinking water or a beverage of their choice. No surgery or invasive procedures are involved.",[9],[21],"Earflo (Model EF001)",[23],{"name":24,"affiliation":5,"role":25},"Philip L Perez, MD","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":30,"email":31},"Zarna P Lalwani, BDS, MPH","CONTACT",null,"zpl5@pitt.edu",[33,46,51,57],{"facility":34,"status":30,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":30},"Eye and Ear Institute \u002F UPMC Presbyterian","Pittsburgh","Pennsylvania","15213","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-79.99589,40.44062,{"lat":44,"lon":43},{"facility":47,"status":30,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":48,"geoPoint":50,"contacts":30},"UPMC Montefiore",{"type":41,"coordinates":49},[43,44],{"lat":44,"lon":43},{"facility":52,"status":30,"city":35,"state":36,"zip":53,"country":38,"countryCode":39,"cosmosGeoPoint":54,"geoPoint":56,"contacts":30},"UPMC Mercy","15219",{"type":41,"coordinates":55},[43,44],{"lat":44,"lon":43},{"facility":58,"status":30,"city":35,"state":36,"zip":59,"country":38,"countryCode":39,"cosmosGeoPoint":60,"geoPoint":62,"contacts":30},"UPMC Shadyside","15232",{"type":41,"coordinates":61},[43,44],{"lat":44,"lon":43},{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Philip Perez","Assistant Professor",[68],{"name":69,"class":70},"Earflo Inc.","UNKNOWN","100652552","earflo-a-non-invasive-treatment-for-otitis-media-with-effusion--eustachian-tube-dysfunction-in-adults-100652552",false,"NCT07777302","EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Adults with confirmed Otitis Media with Effusion (OME) diagnosis with clinical assessment.\n* Adults with confirmed dilatory ETD (Eustachian Tube Dysfunction) on clinical assessment.\n* Willingness to refrain from initiating new treatments for OME\u002FETD (e.g., new surgical or device treatments, tympanostomy tubes) during the study period. Standard care will not be refrained if needed.\n\nExclusion Criteria:\n\n* Presence of acute otitis media, ear infection, or otorrhea within the past 4 weeks.\n* Any medical, psychiatric, or cognitive condition that, in the opinion of the investigators, would interfere with study participation or compliance.\n* Inability to use the EarFlo device as instructed (e.g., due to severe nasal obstruction, craniofacial anomalies, or neuromuscular disorders).\n* Recent eye, ear or nose surgeries or ear trauma. (\\\u003C4 weeks)","ALL","18 Years",{"count":80,"type":81},100,"ESTIMATED","INTERVENTIONAL",[84],"NA","This study evaluates the use of the EarFlo device in adults with clinically confirmed Eustachian tube dysfunction and\u002For otitis media with effusion. The purpose of the study is to assess the safety, tolerability, and short-term effects of device use on ear pressure symptoms and middle ear function.\n\nParticipants will complete a brief symptom questionnaire, undergo routine ear examinations and testing, and use the EarFlo device once during a clinic visit. Ear examination and testing will be repeated after device use to evaluate any short-term changes. This study involves a single study visit and does not include any surgical or invasive procedures.",[87,88,89],"Otitis Media With Effusion (OME)","Eustachian Tube Dysfunction","Otitis Media With Effusion",[91,92,93,88,94,95,96,97,98],"OME","ETD","Otitis Media with Effusion","EarFlo","Noninvasive Device","Middle Ear Function","Ear Pressure symptoms","autoinflation","NOT_YET_RECRUITING","2026-08-18",{"date":102,"type":103},"2026-08-20","ACTUAL",{"date":105,"type":81},"2026-08-27",{"date":107,"type":81},"2028-05-15",{"name":65,"class":6},4]