Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

Qualifiers

Aged between 18 and 85 years

Clinical symptoms of OETD with Eustachian tubal score less or equal to 7/14

Failure of well conducted medical treatment (GERD, allergy, rhinosinusitis) including pressure equalization device used for 1 month or more

ASA score 1 or 2 (ASA : American Society of Anesthesiologists)

Disqualifiers

Palatal cleft

Anatomical anomaly of pharyngeal Eustachian tube ostium on the treated side

Medical history of nasopharyngeal radiotherapy

Medical history of middle ear surgery (except myringotomy and/or tympanostomy tube)

Trial design

Treatments tested in this trial

  • Balloon Eustachian Tuboplasty (BET) under general anesthesia.
  • Insertion of catheter for probing and flushing the Eustachian tube under general anesthesia

Treatment groups

96 Participants
are divided into 2 treatment groups

Locations

This trial has no locations