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

NANot yet recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

July 1, 2026

Study Completion Date

January 1, 2027

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.

All Listed Sponsors
lead

University Hospital, Montpellier

OTHER

NCT05998356 - Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease | Biotech Hunter | Biotech Hunter