[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515964":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":42,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":26},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group (BET procedure)","EXPERIMENTAL","Subjects randomly assigned to the intervention group will benefit from BET procedure",[13],"Device: Balloon Eustachian Tuboplasty (BET) under general anesthesia.",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","Subjects from control group will undergo insertion of catheter for probing and flushing the Eustachian tube, the catheter won't be dilated",[19],"Device: Insertion of catheter for probing and flushing the Eustachian tube under general anesthesia",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Balloon Eustachian Tuboplasty (BET) under general anesthesia.","Subjects will undergo general anesthesia with intubation. After retraction of the inferior turbinate using Naphazoline, the balloon will be inserted under optical control through the pharyngeal ostium of the Eustachian tube and inflated two times at a pressure of 10 bars as instructed by the manufacturer.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Insertion of catheter for probing and flushing the Eustachian tube under general anesthesia","Participants in the control group will benefit from the insertion of a dedicated catheter, TubaClean, into the Eustachian tube during 2 minutes with gentle washing with saline solution, and then the catheter will be removed. This type of device is used to wash the Eustachian tube lumina during ear surgery. Thus, the procedure in the control group will be very close to the BET, except that no dilation will be performed. No Eustachian tube dilation will occur in this control group since the diameter of the catheter itself is not large enough to cause dilation. Eustachian tube catheterization is not per se a treatment of ETD but just of mucosal plugs, and the investigators expect no effect of this catheter insertion on the outcomes of the study. At the end of the procedure, subjects will have nasal dressings similar to the BET procedure to ensure the blinding of the study.",[15],[32],{"name":33,"affiliation":34,"role":35},"Frédéric Venail, MD, PhD","University hospital of Montpellier, FRANCE","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Julia Korchagina, PhD","CONTACT","+33 4 67 33 61 56","julia.korchagina@chu-montpellier.fr",{"type":43,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100515964","long-term-assessment-of-balloon-eustachian-tuboplasty-for-obstructive-eustachian-tube-disease-100515964",false,"NCT05998356","Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease","Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease: A Multicenter Single-blinded Randomized Controlled Study","LASt-BET","Inclusion Criteria:\n\n* Aged between 18 and 85 years\n* Clinical symptoms of OETD with Eustachian tubal score less or equal to 7\u002F14\n* Failure of well conducted medical treatment (GERD, allergy, rhinosinusitis) including pressure equalization device used for 1 month or more\n* ASA score 1 or 2 (ASA : American Society of Anesthesiologists)\n\nExclusion Criteria:\n\n* Palatal cleft\n* Anatomical anomaly of pharyngeal Eustachian tube ostium on the treated side\n* Medical history of nasopharyngeal radiotherapy\n* Medical history of middle ear surgery (except myringotomy and\u002For tympanostomy tube)\n* Eardrum perforation in the treated side\n* Contraindication of general anesthesia, or major risk of general anesthesia including ASA scores of 3 and 4\n* Major nasal obstruction ipsilateral to the Eustachian tube to treat\n* Medical history of previous Eustachian Tube Dilation\n* Pregnant or nursing woman, or in childbearing age and not willing to use contraception\n* Inclusion in another interventional clinical trial\n* Protected and vulnerable adult\n* Not covered by Health insurance\n* Refusal to sign informed consent form\n* Subjects unable to attend all scheduled visits or to comply with all trial procedures","ALL","18 Years","85 Years",{"count":56,"type":57},96,"ESTIMATED","INTERVENTIONAL",[60],"NA","To date, more than 130 000 Balloon Eustachian Tuboplasty (BET) procedures have been performed worldwide. This procedure is proposed in case of Obstructive Eustachian Tube Dysfunction (OETD) with or without chronic otitis media. However, the effectiveness of this procedure is still discussed amongst otolaryngologist. Most of studies,were open label prospective studies comparing Eustachian tube function before and after surgical treatment. A recent meta-analysis suggests that BET procedure improves postoperative Eustachian tube function, but high-level evidence is still lacking. In this project, the investigators propose to perform the first blinded randomized controlled trial procedure to assess the changes of Eustachian tube function after BET in a population of subjects with chronic OETD with or without chronic otitis. Prognosis factors of efficacy will be also investigated during the study.",[63],"Eustachian Tube Dysfunction",[65,66,67],"Eustachian tube","Balloon Eustachian Tuboplasty","Eustachian Tubal Score","NOT_YET_RECRUITING","2023-09-19",{"date":71,"type":72},"2023-09-21","ACTUAL",{"date":74,"type":57},"2023-10-01",{"date":76,"type":57},"2027-01-01",{"name":5,"class":6}]