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

NCT05998356 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-09-21

No results posted yet for this study

Summary

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.

Conditions

  • Eustachian Tube Dysfunction

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Frédéric Venail, MD, PhD · University hospital of Montpellier, FRANCE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2026-07-01
Completion
2027-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05998356 on ClinicalTrials.gov